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NCT06430801

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

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2029-11-12

Brief Summary

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The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

Detailed Description

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The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Group Type EXPERIMENTAL

SC Tulisokibart

Intervention Type DRUG

Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

Interventions

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IV Tulisokibart

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

Intervention Type DRUG

SC Tulisokibart

Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

Intervention Type DRUG

IV Placebo

Placebo matching IV tulisokibart

Intervention Type OTHER

SC Placebo

Placebo matching SC tulisokibart

Intervention Type OTHER

Other Intervention Names

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PRA023 MK-7240 PRA023 MK-7240

Eligibility Criteria

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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.
* Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.

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) and is disease free for \<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-TL1A antibody.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

2023-508636-61-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1298-6080

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2031240196

Identifier Type: REGISTRY

Identifier Source: secondary_id

7240-008

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Study 1: High Dose Induction, High Dose Maintenance

IV Tulisokibart

SC Tulisokibart

Study 1: High Dose Induction, Low Dose Maintenance

IV Tulisokibart

SC Tulisokibart

SC Placebo

Study 1: Low Dose Induction, Low Dose Maintenance

IV Tulisokibart

SC Tulisokibart

SC Placebo

Study 1: Placebo

IV Tulisokibart

IV Placebo

SC Placebo

Study 1: High Dose Extension

SC Tulisokibart

Study 1: Low Dose Extension

SC Tulisokibart

SC Placebo

Study 2: High Dose Induction

IV Tulisokibart

Study 2: Low Dose Induction

IV Tulisokibart

SC Placebo

Study 2: Placebo

IV Tulisokibart

IV Placebo

SC Placebo

Study 2: High Dose Extension

SC Tulisokibart

Study 2: Low Dose Extension

SC Tulisokibart

Interventions

IV Tulisokibart

SC Tulisokibart

IV Placebo

SC Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Merck Sharp & Dohme LLC

Responsible Party

Principal Investigators

Medical Director

Locations

Digestive Health Specialists ( Site 5064)

Arizona Arthritis & Rheumatology Research, PC ( Site 5094)

GI Alliance - Sun City ( Site 5118)

University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)

Clinnova Research ( Site 5110)

Southern California Research Center ( Site 5044)

Om Research LLC ( Site 5038)

Cedars Sinai Medical Center ( Site 5080)

UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)

Om Research LLC ( Site 5045)

Clinical Applications Laboratories ( Site 5123)

Amicis Research Center - Valencia ( Site 5055)

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)

Peak Gastroenterology Associates ( Site 5023)

South Denver Gastroenterology, PC ( Site 5132)

Rocky Mountain Gastroenterology ( Site 5082)

Medical Research Center of Connecticut ( Site 5005)

Yale University School of Medicine-Digestive Disease ( Site 5019)

Emerson Clinical Research Institute ( Site 5051)

Gastroenterology Consultants of Clearwater ( Site 5052)

Nature Coast Clinical Research - Inverness ( Site 5042)

Atlantic Medical Research ( Site 5073)

Sanchez Clinical Research ( Site 5144)

Endoscopic Research Inc ( Site 5061)