A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. 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 according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. 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 according to the Modified Mayo Score at Week 12.

Key facts

Study ID

NCT06052059

Run by

Merck Sharp & Dohme LLC

People needed

1020

Starts

2023-10-25

Expected to finish

2029-08-01

Last updated by the study team

2026-03-13

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
• Has moderately to severely active UC
• Weight ≥40 kg
• Satisfies at least 1 of the following criteria:
• Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
• Protocol specified corticosteroid dependence
• Has been intolerant to 1 or more protocol-specified UC treatments
• Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
• Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority
• A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy

You may not qualify if…

• Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
• Has a current diagnosis of fulminant colitis and/or toxic megacolon
• Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is \~10 cm from the anal margin)
• Has a current or impending need for colostomy or ileostomy
• Has had a total proctocolectomy or partial colectomy
• Has received fecal microbial transplantation within 4 weeks before randomization
• Has had UC exacerbation requiring hospitalization within 2 weeks before screening
• Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
• Has any active or serious infections without resolution after adequate treatment
• Has had cytomegalovirus infection that resolved less than 4 weeks before screening
• Has a transplanted organ which requires continued immunosuppression
• 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 known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
• Has confirmed or suspected COVID-19
• Has a history of drug or alcohol abuse within 6 months prior to screening
• Has had major surgery within 3 months before screening or has a major surgery planned during the study
• Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
• Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
• Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
• Has received protocol-specified prohibited medications
• Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Where it is running

• IMC-Gulf Coast Gastroenterology ( Site 0157) — Fairhope, Alabama, United States
• Research Solutions of Arizona ( Site 3816) — Litchfield Park, Arizona, United States
• One of a Kind Clinical Research Center ( Site 3852) — Scottsdale, Arizona, United States
• GI Alliance - Sun City ( Site 0103) — Sun City, Arizona, United States
• Clinnova Research ( Site 3803) — Anaheim, California, United States
• Southern California Research Center ( Site 3828) — Coronado, California, United States
• UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113) — La Jolla, California, United States
• Cedars-Sinai Medical Center ( Site 0119) — Los Angeles, California, United States
• University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851) — Orange, California, United States
• University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172) — Aurora, Colorado, United States
• Peak Gastroenterology Associates ( Site 0116) — Colorado Springs, Colorado, United States
• South Denver Gastroenterology, PC ( Site 3849) — Englewood, Colorado, United States
• Rocky Mountain Gastroenterology/Topography Health ( Site 3838) — Littleton, Colorado, United States
• Connecticut Clinical Research Institute ( Site 0126) — Bristol, Connecticut, United States
• Medical Research Center of Connecticut ( Site 0151) — Hamden, Connecticut, United States
• Yale University School of Medicine-Digestive Disease ( Site 0163) — New Haven, Connecticut, United States
• Emerson Clinical Research Institute ( Site 3820) — Washington D.C., District of Columbia, United States
• Gastroenterology Consultants of Clearwater ( Site 0152) — Clearwater, Florida, United States
• University of Florida College of Medicine-Gastroenterology ( Site 3821) — Gainesville, Florida, United States
• Nature Coast Clinical Research - Inverness ( Site 3806) — Inverness, Florida, United States
• Central Florida Gastro Research ( Site 0124) — Kissimmee, Florida, United States
• Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810) — Miami, Florida, United States
• Orlando Health ( Site 0145) — Orlando, Florida, United States
• USF Health ( Site 0169) — Tampa, Florida, United States
• Digestive Health Specialists ( Site 0135) — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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