## Protocol Section
### Identification Module
**NCT ID:** NCT04202679

**Brief Title:** Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

**Official Title:** A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

#### Organization Study ID Info
**ID:** EFC16460
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**ID:** 2019-003801-90
**Domain:** UTN
**ID:** U1111-1241-8174
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2021-11-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-08-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2022-09-28

**Type:** ACTUAL

**Results First Submit Date:** 2022-08-29

**Results First Submit QC Date:** 2022-08-29

#### Start Date
**Date:** 2020-01-16

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2019-12-17
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-16
**Study First Submit QC Date:** 2019-12-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Regeneron Pharmaceuticals

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable.

Secondary Objectives:

To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable.

To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

**Detailed Description:** The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

### Conditions Module

**Conditions:**

- Neurodermatitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 160

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.

**Intervention Names:**

- Drug: Placebo

- Drug: Moisturizers

- Drug: Low to medium potent topical corticosteroids

- Drug: Topical calcineurin inhibitors

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.

**Intervention Names:**

- Drug: Dupilumab SAR231893

- Drug: Moisturizers

- Drug: Low to medium potent topical corticosteroids

- Drug: Topical calcineurin inhibitors

**Label:** Dupilumab 300 mg Q2W

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dupilumab 300 mg Q2W

**Description:** Pharmaceutical form:Injection solution Route of administration: Subcutaneous

**Name:** Dupilumab SAR231893

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Pharmaceutical form:Injection solution Route of administration: Subcutaneous

**Name:** Placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Dupilumab 300 mg Q2W

- Placebo

**Description:** Pharmaceutical form:

Route of administration: Topical

**Name:** Moisturizers

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Dupilumab 300 mg Q2W

- Placebo

**Description:** Pharmaceutical form:

Route of administration: Topical

**Name:** Low to medium potent topical corticosteroids

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Dupilumab 300 mg Q2W

- Placebo

**Description:** Pharmaceutical form:

Route of administration: Topical

**Name:** Topical calcineurin inhibitors

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure.

**Measure:** Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12

**Time Frame:** Baseline, Week 12

#### Secondary Outcomes

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 24 is reported in this outcome measure.

**Measure:** Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24

**Time Frame:** Baseline, Week 24

**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.

**Measure:** Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24

**Time Frame:** At Week 24

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch), higher scores indicated more severity. IGA PN-S assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicated greater severity. Percentage of participants with both an improvement (reduction) in WI-NRS by \>=4 Points (from Baseline) and an IGA PN-S score of 0 or 1 were reported in this outcome measure.

**Measure:** Percentage of Participants With Both an Improvement (Reduction) in WI-NRS by >=4 Points and an IGA PN-S Score of 0 or 1 From Baseline at Week 24

**Time Frame:** Baseline, Week 24

**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.

**Measure:** Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12

**Time Frame:** At Week 12

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.

**Measure:** Percent Change From Baseline in WI-NRS Scores at Week 24

**Time Frame:** Baseline, Week 24

**Description:** DLQI is developed to measure dermatology specific HRQoL in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. LS means and SE were obtained from ANCOVA model.

**Measure:** Change From Baseline in Health-related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24

**Time Frame:** Baseline, Week 24

**Description:** Skin Pain-NRS was used to measure skin pain intensity. Participants were asked daily to rate the intensity of their worst skin pain over the past 24 hours, using a 11-point scale ranging from 0 ("No pain") to 10 ("Worst possible pain"). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.

**Measure:** Change From Baseline in Skin Pain-NRS at Week 24

**Time Frame:** Baseline, Week 24

**Description:** Sleep-NRS was used to measure sleep intensity. Participants were asked to rate their sleep quality on their past night upon awakening, using a 11-point NRS ranging from 0 to 10, where 0 = worst possible sleep and 10 = best possible sleep. Higher scores indicated less severity. LS means and SE were obtained from ANCOVA model.

**Measure:** Change From Baseline in Sleep-NRS at Week 24

**Time Frame:** Baseline, Week 24

**Description:** HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale comprised of 7 items with a scoring range from 0 (less severity of anxiety and depression) to 21 (greater severity of anxiety and depression symptoms) for each subscale. The total HADS score ranges from 0 (less severity) to 42 (more severity), with a high score indicative of a severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.

**Measure:** Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24

**Time Frame:** Baseline, Week 24

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Probability of participants with an improvement (reduction) in WI-NRS at Week 24 was based on Kaplan-Meier estimates and was reported in this outcome measure.

**Measure:** Probability of Participants With an Improvement (Reduction) in WI-NRS by >=4 From Baseline at Week 24

**Time Frame:** Baseline, Week 24

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.

**Measure:** Change From Baseline in WI-NRS Scores at Weeks 12 and 24

**Time Frame:** Baseline, Weeks 12 and 24

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.

**Measure:** Percent Change From Baseline in WI-NRS Scores at Weeks 2, 4 and 12

**Time Frame:** Baseline, Weeks 2, 4 and 12

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.

**Measure:** Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

**Time Frame:** Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (Reduction) in WI-NRS scale by \>=4 Points at Week 4 is reported in this outcome measure.

**Measure:** Percentage of Participants With Improvement (Reduction) in WI-NRS >=4 Points From Baseline at Week 4

**Time Frame:** Baseline, Week 4

**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants achieving \>=4 points improvement (reduction) from Baseline in WI-NRS scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 is reported in this outcome measure.

**Measure:** Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

**Time Frame:** Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

**Description:** Onset of action was defined as the first p\<0.05 difference from placebo in the weekly average WI-NRS that remained significant at subsequent measurements. WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated greater severity.

**Measure:** Onset of Action Based on Change From Baseline in WI-NRS at Week 4

**Time Frame:** Baseline, Week 4

**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.

**Measure:** Percentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) Score of 0 or 1 at Weeks 4 and 8

**Time Frame:** At Weeks 4 and 8

**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. LS means and SE were obtained from ANCOVA model.

**Measure:** Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24

**Time Frame:** Baseline, Weeks 4, 8, 12, and 24

**Description:** The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear (0% nodules showing excoriations/crusts), 1 = almost clear (up to 10% nodules showing excoriations/crusts), 2 = mild (11-25% nodules showing excoriations/crusts), 3 = moderate (26-75% nodules showing excoriations/crusts) and 4 = severe (76-100% of nodules showing excoriations/crusts). Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-A score of either 0 (clear) or 1 (almost clear) has been reported.

**Measure:** Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) Score of 0 or 1 at Weeks 4, 8, 12 and 24

**Time Frame:** At Weeks 4, 8, 12 and 24

**Description:** DLQI is developed to measure dermatology specific HRQoL in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. LS means and SE were obtained from ANCOVA model.

**Measure:** Change From Baseline in HRQoL, as Measured by DLQI at Week 12

**Time Frame:** Baseline, Week 12

**Description:** An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent (TE) period (time from the first investigational medicinal product \[IMP\] administration to the last IMP administration + 14 weeks).

**Measure:** Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

**Time Frame:** From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)

**Description:** ADA response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs were defined as a participant with no positive assay response at baseline but with a positive assay response during the entire TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the TE period (time from the first IMP administration to the last IMP administration + 14 weeks). Titer values were defined as low titer (\< 1,000); moderate (1,000 \<= titer \<= 10,000) and high titer (\> 10,000).

**Measure:** Number of Participants With Treatment-emergent and Treatment Boosted Antidrug Antibodies (ADA)

**Time Frame:** From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria :

Must be 18 to 80 years of age, at the time of signing the informed consent.

With a clinical diagnosis of PN defined by all of the following:

* Diagnosed by a dermatologist for at least 3 months before the Screening visit.
* On the Worst Itch Numeric Rating Scale (WI-NRS) ranging from 0 to 10, participants must have an average worst itch score of \>=7 in the 7 days prior to Day1.
* Participants must have a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at Screening visit and Day 1
* History of failing a 2-week course of medium-to-superpotent topical corticosteroids (TCS) or when TCS are not medically advisable
* Have applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1.

Must be willing and able to complete a daily symptom eDiary for the duration of the study.

Exclusion criteria:

Participants were excluded from the study if any of the following criteria apply:

* Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere with the assessment of the study outcomes.
* PN secondary to medications.
* PN secondary to medical conditions such as neuropathy or psychiatric disease.
* Within 6 months before the screening visit, or documented diagnosis of moderate to severe atopic dermatitis from screening visit to randomization visit.
* Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study.
* Severe renal conditions (eg, participants with uremia and/or on dialysis).
* Participants with uncontrolled thyroid disease.
* Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
* Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization.
* Active chronic or acute infection (except HIV) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period.
* Known or suspected immunodeficiency.
* Active malignancy or history of malignancy within 5 years before the Baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Fort Smith

**Country:** United States

**Facility:** Investigational Site Number :8400054

**State:** Arkansas

**Zip:** 72916

**Location 2:**

**City:** Sacramento

**Country:** United States

**Facility:** Investigational Site Number :8400008

**State:** California

**Zip:** 95816

**Location 3:**

**City:** Pembroke Pines

**Country:** United States

**Facility:** Investigational Site Number :8400005

**State:** Florida

**Zip:** 33028

**Location 4:**

**City:** Plainfield

**Country:** United States

**Facility:** Investigational Site Number :8400002

**State:** Indiana

**Zip:** 46168

**Location 5:**

**City:** Baltimore

**Country:** United States

**Facility:** Investigational Site Number :8400003

**State:** Maryland

**Zip:** 21205

**Location 6:**

**City:** East Windsor

**Country:** United States

**Facility:** Investigational Site Number :8400006

**State:** New Jersey

**Zip:** 08520

**Location 7:**

**City:** Sugar Land

**Country:** United States

**Facility:** Investigational Site Number :8400001

**State:** Texas

**Zip:** 77479

**Location 8:**

**City:** Calgary

**Country:** Canada

**Facility:** Investigational Site Number :1240002

**State:** Alberta

**Zip:** T2G 1B1

**Location 9:**

**City:** Surrey

**Country:** Canada

**Facility:** Investigational Site Number :1240006

**State:** British Columbia

**Zip:** V3R 6A7

**Location 10:**

**City:** Markham

**Country:** Canada

**Facility:** Investigational Site Number :1240007

**State:** Ontario

**Zip:** L3P 1X3

**Location 11:**

**City:** Newmarket

**Country:** Canada

**Facility:** Investigational Site Number :1240008

**State:** Ontario

**Zip:** L3Y 5G8

**Location 12:**

**City:** Toronto

**Country:** Canada

**Facility:** Investigational Site Number :1240001

**State:** Ontario

**Zip:** M5A 3R6

**Location 13:**

**City:** Saskatoon

**Country:** Canada

**Facility:** Investigational Site Number :1240009

**State:** Saskatchewan

**Zip:** S7K 0H6

**Location 14:**

**City:** Valdivia

**Country:** Chile

**Facility:** Investigational Site Number :1520005

**State:** Los Ríos

**Zip:** 5110683

**Location 15:**

**City:** Osorno

**Country:** Chile

**Facility:** Investigational Site Number :1520006

**State:** Reg Metropolitana De Santiago

**Zip:** 5311523

**Location 16:**

**City:** Santiago

**Country:** Chile

**Facility:** Investigational Site Number :1520003

**State:** Reg Metropolitana De Santiago

**Zip:** 7580206

**Location 17:**

**City:** Santiago

**Country:** Chile

**Facility:** Investigational Site Number :1520001

**State:** Reg Metropolitana De Santiago

**Zip:** 7640881

**Location 18:**

**City:** Santiago

**Country:** Chile

**Facility:** Investigational Site Number :1520004

**State:** Reg Metropolitana De Santiago

**Zip:** 80004005

**Location 19:**

**City:** Santiago

**Country:** Chile

**Facility:** Investigational Site Number :1520002

**Location 20:**

**City:** Bordeaux

**Country:** France

**Facility:** Investigational Site Number :2500007

**Zip:** 33075

**Location 21:**

**City:** Brest

**Country:** France

**Facility:** Investigational Site Number :2500001

**Zip:** 29200

**Location 22:**

**City:** Le Mans

**Country:** France

**Facility:** Investigational Site Number :2500008

**Zip:** 72037

**Location 23:**

**City:** Lille

**Country:** France

**Facility:** Investigational Site Number :2500002

**Zip:** 59037

**Location 24:**

**City:** Lyon

**Country:** France

**Facility:** Investigational Site Number :2500006

**Zip:** 69003

**Location 25:**

**City:** Paris

**Country:** France

**Facility:** Investigational Site Number :2500004

**Zip:** 75010

**Location 26:**

**City:** Reims

**Country:** France

**Facility:** Investigational Site Number :2500005

**Zip:** 51100

**Location 27:**

**City:** Toulouse

**Country:** France

**Facility:** Investigational Site Number :2500003

**Zip:** 31059

**Location 28:**

**City:** Debrecen

**Country:** Hungary

**Facility:** Investigational Site Number :3480004

**Zip:** 4032

**Location 29:**

**City:** Orosháza

**Country:** Hungary

**Facility:** Investigational Site Number :3480002

**Zip:** 5900

**Location 30:**

**City:** Pécs

**Country:** Hungary

**Facility:** Investigational Site Number :3480005

**Zip:** 7632

**Location 31:**

**City:** Szeged

**Country:** Hungary

**Facility:** Investigational Site Number :3480003

**Zip:** 6720

**Location 32:**

**City:** Rozzano

**Country:** Italy

**Facility:** Investigational Site Number :3800001

**State:** Milano

**Zip:** 20089

**Location 33:**

**City:** Ancona

**Country:** Italy

**Facility:** Investigational Site Number :3800004

**Zip:** 60032

**Location 34:**

**City:** Catanzaro

**Country:** Italy

**Facility:** Investigational Site Number :3800003

**Zip:** 88100

**Location 35:**

**City:** Milano

**Country:** Italy

**Facility:** Investigational Site Number :3800002

**Zip:** 20122

**Location 36:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Investigational Site Number :4100002

**State:** Busan-gwangyeoksi

**Zip:** 49241

**Location 37:**

**City:** Bucheon-si

**Country:** Korea, Republic of

**Facility:** Investigational Site Number :4100003

**State:** Gyeonggi-do

**Zip:** 14584

**Location 38:**

**City:** Incheon

**Country:** Korea, Republic of

**Facility:** Investigational Site Number :4100007

**State:** Incheon-gwangyeoksi

**Zip:** 21431

**Location 39:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Investigational Site Number :4100005

**State:** Seoul-teukbyeolsi

**Zip:** 03722

**Location 40:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Investigational Site Number :4100001

**State:** Seoul-teukbyeolsi

**Zip:** 06973

**Location 41:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Investigational Site Number :4100006

**State:** Seoul-teukbyeolsi

**Zip:** 07441

**Location 42:**

**City:** Coimbra

**Country:** Portugal

**Facility:** Investigational Site Number :6200001

**Zip:** 3000-075

**Location 43:**

**City:** Lisboa

**Country:** Portugal

**Facility:** Investigational Site Number :6200002

**Zip:** 1998-018

**Location 44:**

**City:** Porto

**Country:** Portugal

**Facility:** Investigational Site Number :6200003

**Zip:** 4099-001

**Location 45:**

**City:** Santullano

**Country:** Spain

**Facility:** Investigational Site Number :7240008

**State:** Asturias

**Zip:** 33619

**Location 46:**

**City:** Badalona

**Country:** Spain

**Facility:** Investigational Site Number :7240009

**State:** Barcelona [Barcelona]

**Zip:** 08916

**Location 47:**

**City:** Pontevedra

**Country:** Spain

**Facility:** Investigational Site Number :7240001

**State:** Galicia [Galicia]

**Zip:** 36071

**Location 48:**

**City:** Córdoba

**Country:** Spain

**Facility:** Investigational Site Number :7240004

**Zip:** 14004

**Location 49:**

**City:** Madrid

**Country:** Spain

**Facility:** Investigational Site Number :7240007

**Zip:** 28034

**Location 50:**

**City:** Valencia

**Country:** Spain

**Facility:** Investigational Site Number :7240003

**Zip:** 46026

**Location 51:**

**City:** Zaragoza

**Country:** Spain

**Facility:** Investigational Site Number :7240002

**Zip:** 50009

**Location 52:**

**City:** Hsinchu City

**Country:** Taiwan

**Facility:** Investigational Site Number :1580005

**Zip:** 30059

**Location 53:**

**City:** Kaohsiung

**Country:** Taiwan

**Facility:** Investigational Site Number :1580006

**Zip:** 833

**Location 54:**

**City:** Taichung

**Country:** Taiwan

**Facility:** Investigational Site Number :1580008

**Location 55:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Investigational Site Number :1580001

**Zip:** 10002

**Location 56:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Investigational Site Number :1580002

**Zip:** 10449

**Location 57:**

**City:** Redhill

**Country:** United Kingdom

**Facility:** Investigational Site Number :8260001

**State:** Surrey

**Zip:** RH1 5RH

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi

**Name:** Clinical Sciences & Operations

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

**IPD Sharing:** YES

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-05-20

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1478945

- Type Abbrev: Prot

- Upload Date: 2022-08-23T15:51

- Date: 2021-08-08

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 801691

- Type Abbrev: SAP

- Upload Date: 2022-08-23T15:53

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000003872

- Term: Dermatitis

- ID: D000017443

- Term: Skin Diseases, Eczematous

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14395

- Name: Prurigo

- Relevance: HIGH

- As Found: Prurigo

- ID: M12394

- Name: Neurodermatitis

- Relevance: HIGH

- As Found: Neurodermatitis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7067

- Name: Dermatitis

- Relevance: LOW

- As Found: Unknown

- ID: M19712

- Name: Skin Diseases, Eczematous

- Relevance: LOW

- As Found: Unknown

- ID: T4769

- Name: Prurigo Nodularis

- Relevance: HIGH

- As Found: Prurigo Nodularis

### Condition Browse Module - Meshes

- ID: D000011536

- Term: Prurigo

- ID: D000009450

- Term: Neurodermatitis

### Intervention Browse Module - Ancestors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M30452

- Name: Calcineurin Inhibitors

- Relevance: HIGH

- As Found: PMR

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000065095

- Term: Calcineurin Inhibitors

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Reported AEs were TEAEs that developed/worsened in grade or became serious during TE period (defined as the time from the first IMP administration to the last IMP administration + 14 weeks). Analysis was performed on safety population.

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Deaths Num At Risk:** 82

**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.

**ID:** EG000

**Other Num Affected:** 10

**Other Num at Risk:** 82

**Serious Number Affected:** 4

**Serious Number At Risk:** 82

**Title:** Placebo

**Group ID:** EG001

**Title:** Dupilumab 300 mg Q2W

**Deaths Num At Risk:** 77

**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.

**ID:** EG001

**Other Num Affected:** 11

**Other Num at Risk:** 77

**Serious Number Affected:** 2

**Serious Number At Risk:** 77

**Title:** Dupilumab 300 mg Q2W

**Frequency Threshold:** 5

#### Other Events

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

**Term:** Accidental Overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 24.1

#### Serious Events

**Term:** Pelvic Inflammatory Disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 82

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 77

**Num Events:** 1

**Term:** Pyelonephritis Acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 82

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 77

**Num Events:** 1

**Term:** Cutaneous T-Cell Lymphoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 77

**Term:** Large Granular Lymphocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 77

**Term:** Lipoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 82

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 77

**Num Events:** 1

**Term:** Uterine Leiomyoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 82

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 77

**Num Events:** 1

**Term:** Cauda Equina Syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 77

**Term:** Cholecystitis Acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 77

**Term:** Rotator Cuff Syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 82

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 77

**Time Frame:** From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 82

**Group ID:** BG001

**Value:** 78

**Group ID:** BG002

**Value:** 160

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy TCS/TCI at stable dose.

### Group

**ID:** BG001

**Title:** Dupilumab 300 mg Q2W

**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.2

**Value:** 46.7

#### Measurement

**Group ID:** BG001

**Spread:** 15.8

**Value:** 51.0

#### Measurement

**Group ID:** BG002

**Spread:** 15.6

**Value:** 48.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 103

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 57

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 27

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 52

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 48

#### Measurement

**Group ID:** BG001

**Value:** 48

#### Measurement

**Group ID:** BG002

**Value:** 96

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** Analysis was performed on randomized population.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** Contact-US@sanofi.com
**Organization:** Sanofi aventis recherche & développement
**Phone:** 800-633-1610
**Phone Extension:** 6#
**Title:** Trial Transparency Team
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 1.08
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.00
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0216
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 2.3
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 3.56
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 22.66
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 9.0
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 2.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 9.55
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 4.4
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 2.03
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 18.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0001
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 6.1
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 1.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.52
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0194
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 2.9
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -33.81
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -12.51
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** LS mean difference
**Parameter Value:** -23.16
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** -8.42
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -4.36
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** LS mean difference
**Parameter Value:** -6.39
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -2.49
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.73
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0003
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** LS mean difference
**Parameter Value:** -1.61
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** -0.22
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.30
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.1658
**P-Value Comment:** Threshold of significance at 0.05 level.
**Parameter Type:** LS mean difference
**Parameter Value:** 0.54
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
#### Analysis
**CI Lower Limit:** -1.18
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.04
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Dupilumab 300 mg q2w versus Placebo
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0370
**P-Value Comment:** Threshold of significance was \<0.05.
**Parameter Type:** LS mean difference
**Parameter Value:** -0.61
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.9
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.1
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25.6
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.21
- **Upper Limit:** 
- **Value:** -36.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.39
- **Upper Limit:** 
- **Value:** -59.34
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.18
- **Upper Limit:** 
- **Value:** -6.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.21
- **Upper Limit:** 
- **Value:** -13.16
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.51
- **Upper Limit:** 
- **Value:** -2.74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.53
- **Upper Limit:** 
- **Value:** -4.35
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.45
- **Upper Limit:** 
- **Value:** 0.76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.46
- **Upper Limit:** 
- **Value:** 1.30
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.03
- **Upper Limit:** 
- **Value:** -2.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.06
- **Upper Limit:** 
- **Value:** -5.55
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.250
- **Spread:** 
- **Upper Limit:** 0.457
- **Value:** 0.353
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.552
- **Spread:** 
- **Upper Limit:** 0.764
- **Value:** 0.670
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.46
- **Upper Limit:** 
- **Value:** -3.04
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.47
- **Upper Limit:** 
- **Value:** -4.11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.53
- **Upper Limit:** 
- **Value:** -3.10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.54
- **Upper Limit:** 
- **Value:** -5.05
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.06
- **Upper Limit:** 
- **Value:** -15.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.15
- **Upper Limit:** 
- **Value:** -17.41
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 81
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.00
- **Upper Limit:** 
- **Value:** -22.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.12
- **Upper Limit:** 
- **Value:** -30.09
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 81
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.42
- **Upper Limit:** 
- **Value:** -35.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.59
- **Upper Limit:** 
- **Value:** -48.86
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.12
- **Upper Limit:** 
- **Value:** -9.49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.18
- **Upper Limit:** 
- **Value:** -8.66
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 82
- **Group ID:** OG001
- **Value:** 78
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.06
- **Upper Limit:** 
- **Value:** -15.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.15
- **Upper Limit:** 
- **Value:** -17.41
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 81
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.66
- **Upper Limit:** 
- **Value:** -20.44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.77
- **Upper Limit:** 
- **Value:** -25.26
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 81
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.00
- **Upper Limit:** 
- **Value:** -22.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.12
- **Upper Limit:** 
- **Value:** -30.09
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 81
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.21
- **Upper Limit:** 
- **Value:** -25.21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.33
- **Upper Limit:** 
- **Value:** -34.41
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 81
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.33
- **Upper Limit:** 
- **Value:** -27.87
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.46
- **Upper Limit:** 
- **Value:** -36.98
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 80
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.69
- **Upper Limit:** 
- **Value:** -28.99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.84
- **Upper Limit:** 
- **Value:** -39.30
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 78
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.56
- **Upper Limit:** 
- **Value:** -30.45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.70
- **Upper Limit:** 
- **Value:** -41.32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.89
- **Upper Limit:** 
- **Value:** -34.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.04
- **Upper Limit:** 
- **Value:** -47.08
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.04
- **Upper Limit:** 
- **Value:** -32.90
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.20
- **Upper Limit:** 
- **Value:** -44.65
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 78
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.25
- **Upper Limit:** 
- **Value:** -34.64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.41
- **Upper Limit:** 
- **Value:** -45.98
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.42
- **Upper Limit:** 
- **Value:** -35.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.59
- **Upper Limit:** 
- **Value:** -48.86
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.69
- **Upper Limit:** 
- **Value:** -34.49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.86
- **Upper Limit:** 
- **Value:** -48.32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.71
- **Upper Limit:** 
- **Value:** -36.60
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.88
- **Upper Limit:** 
- **Value:** -50.67
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.74
- **Upper Limit:** 
- **Value:** -35.96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.91
- **Upper Limit:** 
- **Value:** -51.89
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.74
- **Upper Limit:** 
- **Value:** -37.80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.91
- **Upper Limit:** 
- **Value:** -54.36
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 77
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.98
- **Upper Limit:** 
- **Value:** -39.15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.15
- **Upper Limit:** 
- **Value:** -55.95
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 77
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.15
- **Upper Limit:** 
- **Value:** -40.38
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.32
- **Upper Limit:** 
- **Value:** -56.80
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 77
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.05
- **Upper Limit:** 
- **Value:** -40.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.23
- **Upper Limit:** 
- **Value:** -57.75
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 76
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.94
- **Upper Limit:** 
- **Value:** -36.12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.10
- **Upper Limit:** 
- **Value:** -56.80
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.16
- **Upper Limit:** 
- **Value:** -36.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.34
- **Upper Limit:** 
- **Value:** -56.91
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.19
- **Upper Limit:** 
- **Value:** -37.34
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.33
- **Upper Limit:** 
- **Value:** -58.78
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.19
- **Upper Limit:** 
- **Value:** -36.87
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.32
- **Upper Limit:** 
- **Value:** -59.43
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 73
- **Group ID:** OG001
- **Value:** 75
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.21
- **Upper Limit:** 
- **Value:** -36.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.39
- **Upper Limit:** 
- **Value:** -59.34
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.7
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.7
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.33
- **Upper Limit:** 
- **Value:** -1.94
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.34
- **Upper Limit:** 
- **Value:** -2.55
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.4
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.13
- **Upper Limit:** 
- **Value:** -0.54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.13
- **Upper Limit:** 
- **Value:** -0.69
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 80
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.17
- **Upper Limit:** 
- **Value:** -0.79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.17
- **Upper Limit:** 
- **Value:** -1.19
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 76
- **Group ID:** OG001
- **Value:** 76
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.18
- **Upper Limit:** 
- **Value:** -0.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.18
- **Upper Limit:** 
- **Value:** -1.47
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 78
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -1.07
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.20
- **Upper Limit:** 
- **Value:** -2.03
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 74
- **Group ID:** OG001
- **Value:** 77
**Units:** Participants
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.3
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.12
- **Upper Limit:** 
- **Value:** -7.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.16
- **Upper Limit:** 
- **Value:** -12.07
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on intent-to-treat (ITT) population which included all participants with a treatment kit number allocated and recorded in the IRT database analyzed according to the treatment group allocated by randomization regardless of if treatment kit was used or not.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 12
**Title:** Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 2
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 24 is reported in this outcome measure.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Percentage of Participants With >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Week 24
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 3
**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** At Week 24
**Title:** Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 4
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch), higher scores indicated more severity. IGA PN-S assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicated greater severity. Percentage of participants with both an improvement (reduction) in WI-NRS by \>=4 Points (from Baseline) and an IGA PN-S score of 0 or 1 were reported in this outcome measure.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Percentage of Participants With Both an Improvement (Reduction) in WI-NRS by >=4 Points and an IGA PN-S Score of 0 or 1 From Baseline at Week 24
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 5
**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** At Week 12
**Title:** Percentage of Participants With IGA PN-S Scores of 0 or 1 at Week 12
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 6
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Percent Change From Baseline in WI-NRS Scores at Week 24
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 7
**Description:** DLQI is developed to measure dermatology specific HRQoL in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Change From Baseline in Health-related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 8
**Description:** Skin Pain-NRS was used to measure skin pain intensity. Participants were asked daily to rate the intensity of their worst skin pain over the past 24 hours, using a 11-point scale ranging from 0 ("No pain") to 10 ("Worst possible pain"). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Change From Baseline in Skin Pain-NRS at Week 24
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 9
**Description:** Sleep-NRS was used to measure sleep intensity. Participants were asked to rate their sleep quality on their past night upon awakening, using a 11-point NRS ranging from 0 to 10, where 0 = worst possible sleep and 10 = best possible sleep. Higher scores indicated less severity. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Change From Baseline in Sleep-NRS at Week 24
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 10
**Description:** HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale comprised of 7 items with a scoring range from 0 (less severity of anxiety and depression) to 21 (greater severity of anxiety and depression symptoms) for each subscale. The total HADS score ranges from 0 (less severity) to 42 (more severity), with a high score indicative of a severe anxiety and/or depression level. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 24
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 11
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Probability of participants with an improvement (reduction) in WI-NRS at Week 24 was based on Kaplan-Meier estimates and was reported in this outcome measure.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 24
**Title:** Probability of Participants With an Improvement (Reduction) in WI-NRS by >=4 From Baseline at Week 24
**Type:** SECONDARY
**Unit of Measure:** probability of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 12
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 12 and 24
**Title:** Change From Baseline in WI-NRS Scores at Weeks 12 and 24
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 13
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 2, 4 and 12
**Title:** Percent Change From Baseline in WI-NRS Scores at Weeks 2, 4 and 12
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 14
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
**Title:** Percent Change From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 15
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (Reduction) in WI-NRS scale by \>=4 Points at Week 4 is reported in this outcome measure.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 4
**Title:** Percentage of Participants With Improvement (Reduction) in WI-NRS >=4 Points From Baseline at Week 4
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 16
**Description:** WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants achieving \>=4 points improvement (reduction) from Baseline in WI-NRS scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 is reported in this outcome measure.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
**Title:** Percentage of Participants Achieving >=4 Points Improvement (Reduction) From Baseline in WI-NRS Scores at Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 17
**Description:** Onset of action was defined as the first p\<0.05 difference from placebo in the weekly average WI-NRS that remained significant at subsequent measurements. WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated greater severity.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 4
**Title:** Onset of Action Based on Change From Baseline in WI-NRS at Week 4
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 18
**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-S score of either 0 (clear) or 1 (almost clear) has been reported.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** At Weeks 4 and 8
**Title:** Percentage of Participants With Investigator's Global Assessment for PN-Stage (IGA PN-S) Score of 0 or 1 at Weeks 4 and 8
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 19
**Description:** IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 4, 8, 12, and 24
**Title:** Change From Baseline in IGA PN-S Scores at Weeks 4, 8, 12, and 24
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 20
**Description:** The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4: where 0 = clear (0% nodules showing excoriations/crusts), 1 = almost clear (up to 10% nodules showing excoriations/crusts), 2 = mild (11-25% nodules showing excoriations/crusts), 3 = moderate (26-75% nodules showing excoriations/crusts) and 4 = severe (76-100% of nodules showing excoriations/crusts). Higher scores indicate severe prurigo nodularis. In this outcome measure, percentage of participants with IGA PN-A score of either 0 (clear) or 1 (almost clear) has been reported.
**Parameter Type:** NUMBER
**Population Description:** Analysis was performed on ITT population.
**Reporting Status:** POSTED
**Time Frame:** At Weeks 4, 8, 12 and 24
**Title:** Percentage of Participants With Investigator's Global Assessment for PN-Activity (IGA PN-A) Score of 0 or 1 at Weeks 4, 8, 12 and 24
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 21
**Description:** DLQI is developed to measure dermatology specific HRQoL in adult participants. It comprises of set of 10 questions assessing the impact of skin disease on participants' HRQoL over the previous week. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. LS means and SE were obtained from ANCOVA model.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 12
**Title:** Change From Baseline in HRQoL, as Measured by DLQI at Week 12
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 22
**Description:** An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent (TE) period (time from the first investigational medicinal product \[IMP\] administration to the last IMP administration + 14 weeks).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on safety population which included all participants who received at least 1 dose of study intervention analyzed according to the intervention actually received.
**Reporting Status:** POSTED
**Time Frame:** From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
**Title:** Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
#### Outcome Measure 23
**Description:** ADA response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs were defined as a participant with no positive assay response at baseline but with a positive assay response during the entire TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the TE period (time from the first IMP administration to the last IMP administration + 14 weeks). Titer values were defined as low titer (\< 1,000); moderate (1,000 \<= titer \<= 10,000) and high titer (\> 10,000).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis was performed on ADA population which included all participants who received at least one dose of the study drug and had at least one non-missing ADA result after first dose of study drug. Participants were analyzed according to the intervention actually received.
**Reporting Status:** POSTED
**Time Frame:** From the first IMP administration to the last IMP administration + 14 weeks (i.e., up to 36 weeks)
**Title:** Number of Participants With Treatment-emergent and Treatment Boosted Antidrug Antibodies (ADA)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** OG001
**Title:** Dupilumab 300 mg Q2W
### Participant Flow Module
#### Group
**Description:** Participants received placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.
**ID:** FG001
**Title:** Dupilumab 300 mg Q2W
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Poor compliance to protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 23
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 82
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 78
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 82
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 77
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 56
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 72
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 26
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 6
**Pre-Assignment Details:** A total of 160 participants were randomized in 1:1 ratio to receive study interventions (placebo or dupilumab) by interactive response technology (IRT).
**Recruitment Details:** This study was conducted at 57 sites in 11 countries. A total of 221 participants were screened from 16 January 2020 to 24 February 2021, out of which 61 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
**Has Results:** True