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Evaluating Tulisokibart for Active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06052059

This study is testing if a new medication called tulisokibart can help people with moderate to severe ulcerative colitis feel better and stay in remission compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1020 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations423 sites (Dothan, Alabama and 422 other locations)
Trial IDNCT06052059 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of tulisokibart in patients with moderately to severely active ulcerative colitis. It consists of two studies: the first focuses on both induction and maintenance treatment, while the second is limited to induction treatment. Participants will receive either tulisokibart or a placebo, and their clinical remission will be assessed using the Modified Mayo Score at specified weeks. The goal is to determine if tulisokibart is superior to placebo in achieving remission.

Who should consider this trial

Good fit: Ideal candidates include individuals with a diagnosis of ulcerative colitis for at least three months and who have moderately to severely active disease.

Not a fit: Patients who have mild ulcerative colitis or those who have not had an inadequate response to previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from moderately to severely active ulcerative colitis.

How similar studies have performed: Previous studies have shown promise with similar approaches in treating ulcerative colitis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Dothan, Alabama and 422 other locations

+373 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 Ulcerative ColitisInflammatory Bowel Disease
Last reviewed 2026-06-09 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.