Evaluating Tulisokibart for Moderate to Severe Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of tulisokibart in patients with moderately to severely active Crohn's disease. The study consists of two parts: one focusing on both induction and maintenance treatment, and the other on induction treatment alone. Participants will receive either the active drug or a placebo, and outcomes will be measured based on clinical remission and endoscopic response at specified time points. The trial seeks to determine if tulisokibart can provide significant improvements over placebo in managing Crohn's disease symptoms.

Why it matters

Who can join: the full rules

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

Inclusion Criteria:

* Has had a diagnosis of Crohn's disease (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 CD.
* 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-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

Where it's running

• GI Alliance - Sun City ( Site 5118)
  Sun City, Arizona, United States Recruiting
• University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
  Tucson, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences ( Site 5147)
  Little Rock, Arkansas, United States Recruiting
• Clinnova Research ( Site 5110)
  Anaheim, California, United States Recruiting
• Southern California Research Center ( Site 5044)
  Coronado, California, United States Recruiting
• Om Research LLC ( Site 5038)
  Lancaster, California, United States Recruiting

+449 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.