## Protocol Section
### Identification Module
**NCT ID:** NCT06430801

**Brief Title:** A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

**Official Title:** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease

#### Organization Study ID Info
**ID:** 7240-008
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-7240-008
**Type:** OTHER
**Domain:** EU CT
**ID:** 2023-508636-61
**Type:** REGISTRY
**Domain:** UTN
**ID:** U1111-1298-6080
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2029-09-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-09-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-11

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. The primary hypotheses for Study 1 and Study 2 are that tulisokibart is superior to placebo in achieving the coprimary outcome measures of clinical remission by either Crohn's Disease Activity Index (CDAI, primary endpoint recommended by United States Food and Drug Administration \[US/FDA\]) or stool frequency and abdominal pain score (primary endpoint recommended by European Union European Medicines Agency \[EU/EMA\]) and endoscopic response.

### Conditions Module

**Conditions:**

- Crohn's Disease

### 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:** 1200

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants receive high dose induction of intravenous (IV) tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a high dose maintenance of subcutaneous (SC) tulisokibart every 2 weeks (Q2W).

**Intervention Names:**

- Drug: IV Tulisokibart

- Drug: SC Tulisokibart

**Label:** Study 1: High Dose Induction, High Dose Maintenance

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants receive high dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a low dose maintenance of SC tulisokibart every 4 weeks (Q4W).

**Intervention Names:**

- Drug: IV Tulisokibart

- Drug: SC Tulisokibart

- Other: SC Placebo

**Label:** Study 1: High Dose Induction, Low Dose Maintenance

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants receive low dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by a low dose maintenance of SC tulisokibart Q4W.

**Intervention Names:**

- Drug: IV Tulisokibart

- Drug: SC Tulisokibart

- Other: SC Placebo

**Label:** Study 1: Low Dose Induction, Low Dose Maintenance

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants receive IV placebo a total of 4 times on Day 1 and Weeks 2, 6, and 10. This is followed by SC placebo Q2W until week 52. In an extension, participants receive the low dose SC tulisokibart regimen.

**Intervention Names:**

- Other: IV Placebo

- Other: SC Placebo

**Label:** Study 1: Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 5

**Description:** Participants receive high dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10.

**Intervention Names:**

- Drug: IV Tulisokibart

- Drug: SC Tulisokibart

**Label:** Study 2: High Dose Induction

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Participants receive low dose induction of IV tulisokibart a total of 4 times on Day 1 and Weeks 2, 6, and 10.

**Intervention Names:**

- Drug: IV Tulisokibart

- Drug: SC Tulisokibart

**Label:** Study 2: Low Dose Induction

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** Participants receive IV placebo a total of 4 times on Day 1 and Weeks 2, 6, and 10. In an extension, participants receive the low dose SC tulisokibart regimen.

**Intervention Names:**

- Other: IV Placebo

**Label:** Study 2: Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study 1: High Dose Induction, High Dose Maintenance

- Study 1: High Dose Induction, Low Dose Maintenance

- Study 1: Low Dose Induction, Low Dose Maintenance

- Study 2: High Dose Induction

- Study 2: Low Dose Induction

**Description:** Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously

**Name:** IV Tulisokibart

**Other Names:**

- PRA023

- MK-7240

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Study 1: High Dose Induction, High Dose Maintenance

- Study 1: High Dose Induction, Low Dose Maintenance

- Study 1: Low Dose Induction, Low Dose Maintenance

- Study 2: High Dose Induction

- Study 2: Low Dose Induction

**Description:** Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

**Name:** SC Tulisokibart

**Other Names:**

- PRA023

- MK-7240

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Study 1: Placebo

- Study 2: Placebo

**Description:** Placebo matching IV tulisokibart

**Name:** IV Placebo

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Study 1: High Dose Induction, Low Dose Maintenance

- Study 1: Low Dose Induction, Low Dose Maintenance

- Study 1: Placebo

**Description:** Placebo matching SC tulisokibart

**Name:** SC Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.

**Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.

**Measure:** Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in SES-CD from baseline for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12

**Time Frame:** Week 12

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Who Experienced an Adverse Event (AE)

**Time Frame:** Up to approximately 222 weeks

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants who Discontinue Study Intervention due to an AE

**Time Frame:** Up to approximately 208 weeks

**Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented.

**Measure:** Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented.

**Measure:** Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving endoscopic response, as defined by a 50% decrease in SES-CD from baseline for study 2 will be presented.

**Measure:** Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

**Time Frame:** Week 12

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE for study 2 will be presented.

**Measure:** Study 2: Percentage of Participants Who Experienced an AE

**Time Frame:** Up to approximately 182 weeks

**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE for study 2 will be presented.

**Measure:** Study 2: Percentage of Participants who Discontinue Study Intervention due to an AE

**Time Frame:** Up to approximately 168 weeks

#### Secondary Outcomes

**Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.

**Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.

**Measure:** Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving a reduction in CDAI ≥100 points from baseline for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12

**Time Frame:** Week 12

**Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented.

**Measure:** Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12

**Time Frame:** Baseline and Week 12

**Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

**Measure:** Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12

**Time Frame:** Week 12

**Description:** Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score \<150 for study 1 and study 2 will be presented.

**Measure:** Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12

**Time Frame:** Week 12

**Description:** Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a 50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for study 1 and study 2 will be presented.

**Measure:** Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 1 will be presented.

**Measure:** Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

**Measure:** Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving sustained clinical remission, as defined by CDAI score \<150 for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52

**Time Frame:** Week 12 and Week 52

**Description:** The percentage of participants who are in clinical remission as defined by CDAI score \<150 and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving clinical remission as defined by CDAI score \<150 and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52

**Time Frame:** Week 52

**Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 1 will be presented.

**Measure:** Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52

**Time Frame:** Baseline and Week 52

**Description:** The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 1 will be presented.

**Measure:** Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52

**Time Frame:** Baseline and Week 52

**Description:** The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented.

**Measure:** Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52

**Time Frame:** Week 52

**Description:** The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for study 2 will be presented.

**Measure:** Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for study 2 will be presented.

**Measure:** Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

**Time Frame:** Week 12

**Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented.

**Measure:** Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12

**Time Frame:** Week 12

**Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for study 2 will be presented.

**Measure:** Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12

**Time Frame:** Baseline and Week 12

**Description:** The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for study 2 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, descending colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

**Measure:** Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12

**Time Frame:** Week 12

**Description:** The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224 with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for study 2 will be presented.

**Measure:** Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

**Time Frame:** Baseline and Week 12

**Description:** The percentage of participants achieving a reduction in CDAI ≥ 100 points from baseline for study 2 will be presented.

**Measure:** Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6

**Time Frame:** Week 6

**Description:** The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for study 1 will be presented.

**Measure:** Study 2: The percentage of Participants with Ulcer-Free Endoscopy at Week 12

**Time Frame:** Week 12

### Eligibility Module

**Eligibility Criteria:** The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has had a diagnosis of CD at least 3 months before study.
* Has moderately to severely active CD.
* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.

Exclusion Criteria:

* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
* Has current stoma or need for colostomy or ileostomy.
* Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
* Has surgical bowel resection within 3 months of study.
* Has prior or current gastrointestinal dysplasia.
* Has chronic infection requiring ongoing antimicrobial treatment.
* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years.
* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
* Has active tuberculosis.
* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-anti-TL1A antibody.

**Maximum Age:** 75 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

### References Module

#### See Also Links

**Label:** Merck Clinical Trials Information

**URL:** https://www.merckclinicaltrials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015212

- Term: Inflammatory Bowel Diseases

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000007410

- Term: Intestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6638

- Name: Crohn Disease

- Relevance: HIGH

- As Found: Crohn's Disease

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003424

- Term: Crohn Disease

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
