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NCT06052059

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

NCT ID: NCT06052059

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2029-08-01

Brief Summary

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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.

Detailed Description

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The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Conditions

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Ulcerative Colitis

Keywords

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Induction and maintenance treatments will be blinded. Reinduction will not be blinded.

Intervention Type DRUG

Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously

SC Placebo

Intervention Type DRUG

Placebo matching SC tulisokibart

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Identifier Source: secondary_id

7240-001

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Study 1: High Dose Induction, High Dose Maintenance

IV Tulisokibart

SC Tulisokibart

Study 1: High Dose Induction, Low Dose Maintenance

IV Tulisokibart

SC Tulisokibart

SC Placebo

Study 1: Low Dose Induction, Low Dose Maintenance

IV Tulisokibart

SC Tulisokibart

SC Placebo

Study 1: Placebo

IV Tulisokibart

IV Placebo

SC Placebo

Study 1: High Dose Extension

SC Tulisokibart

Study 1: Low Dose Extension

SC Tulisokibart

SC Placebo

Study 2: High Dose Induction

IV Tulisokibart

Study 2: Low Dose Induction

IV Tulisokibart

Study 2: Placebo

IV Tulisokibart

IV Placebo

SC Placebo

Study 2: High Dose Extension

SC Tulisokibart

Study 2: Low Dose Extension

SC Tulisokibart

SC Placebo

Interventions

IV Tulisokibart

IV Placebo

SC Tulisokibart

SC Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

PPD, Part of Thermo Fisher Scientific

Merck Sharp & Dohme LLC

Responsible Party

Principal Investigators

Medical Director

Locations

Digestive Health Specialists ( Site 0135)

IMC-Gulf Coast Gastroenterology ( Site 0157)

Research Solutions of Arizona ( Site 3816)

One of a Kind Clinical Research Center ( Site 3852)

GI Alliance - Sun City ( Site 0103)

Clinnova Research ( Site 3803)

Southern California Research Center ( Site 3828)

UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)

Cedars-Sinai Medical Center ( Site 0119)

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)

Peak Gastroenterology Associates ( Site 0116)

South Denver Gastroenterology, PC ( Site 3849)

Rocky Mountain Gastroenterology/Topography Health ( Site 3838)

Connecticut Clinical Research Institute ( Site 0126)

Medical Research Center of Connecticut ( Site 0151)

Yale University School of Medicine-Digestive Disease ( Site 0163)

Emerson Clinical Research Institute ( Site 3820)

Gastroenterology Consultants of Clearwater ( Site 0152)

University of Florida College of Medicine-Gastroenterology ( Site 3821)

Nature Coast Clinical Research - Inverness ( Site 3806)

Central Florida Gastro Research ( Site 0124)