Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohns Disease
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
1200
Participants Needed
499
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously IV or subcutaneously SC. Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohns Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.
CONDITIONS
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has had a diagnosis of Crohn's disease for at least 3 months before the study.
- Has moderately to severely active Crohn's disease.
- Has had an inadequate response, loss of response, or intolerance to oral steroids, systemic steroids, immunomodulators, biologic or small molecule therapies.
- Adolescents aged 16 to under 18 may participate if approved by local authorities.
- Participants must be between 16 and 80 years old.
- Includes all genders.
You will not qualify if you...
- Has diagnosis of ulcerative colitis or indeterminate colitis.
- Has Crohn's disease isolated to stomach, duodenum, jejunum, or perianal region without colon or ileum involvement.
- Has current complications like abscess, strictures, fulminant colitis, toxic megacolon, or any condition needing surgery during the study.
- Has a current stoma or needs colostomy or ileostomy.
- Missing more than 2 segments among terminal ileum, right colon, transverse colon, sigmoid colon, left colon, and rectum.
- Diagnosed with short gut syndrome or uncontrolled chronic diarrhea besides Crohn's disease.
- Had bowel surgery within 3 months before the study.
- Has gastrointestinal dysplasia.
- Has chronic infection needing ongoing antibiotics.
- History of cancer except treated non-melanoma skin cancers or cervical carcinoma in situ with disease-free period under 5 years.
- Infected with hepatitis B, hepatitis C, or HIV.
- Has active tuberculosis.
- Has confirmed or suspected COVID-19 infection.
- Prior exposure to tulisokibart or other anti-TL1A antibodies.
Research Team
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