## Protocol Section
### Identification Module
**NCT ID:** NCT06415175

**Acronym:** PROADAP

**Brief Title:** Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain

**Official Title:** Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain

#### Organization Study ID Info
**ID:** OBS18427
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**Domain:** ICTRP
**ID:** U1111-1306-7579
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2027-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Regeneron Pharmaceuticals

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.

### Conditions Module

**Conditions:**

- Atopic Dermatitis

**Keywords:**

- Pediatric

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The information will be collected during consultation as part of the patient's usual follow-up.

**Intervention Names:**

- Drug: Dupilumab

**Label:** Dupilumab

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dupilumab

**Description:** This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

**Name:** Dupilumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age

**Time Frame:** At baseline

**Measure:** Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender

**Time Frame:** At baseline

**Measure:** Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)

**Time Frame:** At baseline

**Description:** Including course of AD, recent AD treatment history, family history.

**Measure:** Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD

**Time Frame:** At baseline

**Description:** Selected atopic comorbidities over time will be reported.

**Measure:** Medical history of atopic comorbidities

**Time Frame:** At baseline

**Measure:** Medical history of non-atopic diseases

**Time Frame:** At baseline

#### Secondary Outcomes

**Measure:** Description of real-world treatment patterns: Dupilumab dosage

**Time Frame:** From baseline up to 24 months

**Measure:** Description of real-world treatment patterns: Dupilumab frequency of administration

**Time Frame:** From baseline up to 24 months

**Description:** Reason for discontinuation will be reported if applicable.

**Measure:** Description of real-world treatment patterns: Dupilumab reason for discontinuation

**Time Frame:** From baseline up to 24 months

**Description:** In case of receiving other treatments for AD, topical or systemic.

**Measure:** Description of real-world treatment patterns (other treatments): Other type of treatment

**Time Frame:** From baseline up to 24 months

**Description:** In case of receiving other treatments for AD, topical or systemic.

**Measure:** Description of real-world treatment patterns (other treatments): Name of treatment

**Time Frame:** From baseline up to 24 months

**Description:** In case of receiving other treatments for AD, topical or systemic.

**Measure:** Description of real-world treatment patterns (other treatments): Duration of treatment

**Time Frame:** From baseline up to 24 months

**Description:** In case of receiving other treatments for AD, topical or systemic. Reason for discontinuation will be reported if applicable.

**Measure:** Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)

**Time Frame:** From baseline up to 24 months

**Description:** The Children's Dermatology Life Quality Index (cDLQI) it is a 10-item questionnaire that assesses six different aspects that may affect quality of life, including symptoms and feelings, daily activities, leisure, work and school performance, personal relationships, and treatment. Each of the 10 questions is scored from 0 (not at all) to 3 (very much) and the overall cDLQI is calculated by summing the score of each question, resulting in a total score between 0-30. The higher the score, the more quality of life is impaired.

**Measure:** Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score

**Time Frame:** From baseline up to 24 months

**Description:** The Infant Dermatology Quality of Life Index (iDLQI) contains 10 questions and a response scale divided into four boxes. Each box gives a point between 0 and 3. The lower number is understood as the most positive for the participant.

The index is filled out by a parent to a participating child between the ages of 0 to 5 years.

Points from each question are added together and the end-sum represents the score. The sum score can be between 0 and 30. The higher the score the worse the assumed quality of life.

**Measure:** Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score

**Time Frame:** From baseline up to 24 months

**Description:** The DFI is a 10-item disease specific questionnaire assessing the impact of having a child with AD on family Quality of Life (QoL). The DFI questions are scored ranging from 0 to 3, and the total DFI score ranges from 0 to 30. The time frame of reference is the past week, and a higher DFI score indicates greater impairment in family QoL as affected by AD.

**Measure:** Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire

**Time Frame:** From baseline up to 24 months

**Description:** WI-NRS is a validated measure of itch severity. Patients will be 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 indicate more severity.

**Measure:** Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS)

**Time Frame:** From baseline up to 24 months

**Description:** The WSI-NRS is a single-item caregiver-reported. The caregivers describe their child "scratch" or "itch" in the AD-affected area by using numeric response options (0: no scratching/itching to 10: worst scratching/itching). Higher scores indicate more severity.

**Measure:** Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS)

**Time Frame:** From baseline up to 24 months

**Description:** The EASI is calculated by summing 4 separate scores of the (1) head/neck, (2) upper extremities, (3) trunk, and (4) lower extremities. For each of the 4 anatomical regions, the score formula is SxAxM \["S" is the congregate score from the severity of 4 signs: erythema, oedema/papulation, excoriation, and lichenification graded on a discrete scale from 0 to 3, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe, giving S a maximum of 12. "A" represents the area to which AD affects the body, yielding a maximum of 6 points: 0 = 0%, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. "M" is a multiplier, which is 0.1, 0.2, 0.3, and 0.4, respectively, for the region affected in those ≥8 years and 0.2, 0.2, 0.3, and 0.3, respectively, for those \<8 years. The final EASI score is calculated based on the sum of the scores from the 4 anatomical regions. A higher score means higher AD severity. Scores range from 0 (no disease) to 72 (maximal disease severity).

**Measure:** Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI)

**Time Frame:** From baseline up to 24 months

**Description:** BSA affected by AD disease will be assessed for each major section of the body (head, neck, anterior trunk, back, upper limbs, lower limbs, and genitals). It will be reported as a percentage of all major body sections combined.

**Measure:** Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD

**Time Frame:** From baseline up to 24 months

**Description:** The IGA is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

**Measure:** Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)

**Time Frame:** From baseline up to 24 months

**Description:** Biomarker analysis will be performed, if available, in routine clinical practice and at routine visits

**Measure:** Physician assessment: Change from baseline in Biomarkers

**Time Frame:** From baseline up to 24 months

**Description:** The number of events and the percentage of patients who had at least one event will be described.

**Measure:** Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI)

**Time Frame:** From date of signed ICF, up to 24 months

**Description:** Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, urgent care or emergency room visits.

**Measure:** Health Care Resource Utilization (HCRU) Questionnaire

**Time Frame:** From baseline up to 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female aged 6 months to 11 years old at baseline.
* Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
* Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
* Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.

Exclusion Criteria:

* Patients who are participating in an interventional clinical trial that modifies patient care.

**Maximum Age:** 11 Years

**Minimum Age:** 6 Months

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Patients aged 6 months to 11 years old at baseline and initiating Dupilumab for their Severe Atopic dermatitis (AD) in Spain.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Contact-us@sanofi.com

**Name:** Trial Transparency email recommended (Toll free for US & Canada)

**Phone:** 800-633-1610

**Phone Ext:** option 6

**Role:** CONTACT

#### 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000012873

- Term: Skin Diseases, Genetic

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000017443

- Term: Skin Diseases, Eczematous

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7067

- Name: Dermatitis

- Relevance: HIGH

- As Found: Dermatitis

- ID: M7071

- Name: Dermatitis, Atopic

- Relevance: HIGH

- As Found: Atopic Dermatitis

- ID: M7655

- Name: Eczema

- Relevance: HIGH

- As Found: Atopic Dermatitis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15676

- Name: Skin Diseases, Genetic

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M19712

- Name: Skin Diseases, Eczematous

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003876

- Term: Dermatitis, Atopic

- ID: D000003872

- Term: Dermatitis

- ID: D000004485

- Term: Eczema

### Misc Info Module

- Version Holder: 2024-05-31
