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Evaluating Tulisokibart for Moderate to Severe Crohn's Disease

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

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06430801

This study is testing if a new drug called tulisokibart can help people with moderate to severe Crohn's disease feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1200 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations499 sites (Dothan, Alabama and 498 other locations)
Trial IDNCT06430801 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 16 and older with a diagnosis of Crohn's disease who have not responded adequately to previous treatments.

Not a fit: Patients with ulcerative colitis or those whose Crohn's disease is limited to certain areas of the gastrointestinal tract may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients struggling with moderate to severe Crohn's disease.

How similar studies have performed: Previous studies have shown promise with similar biologic therapies for Crohn's disease, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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.
* 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.

Where this trial is running

Dothan, Alabama and 498 other locations

+449 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.