Recruiting

Phase 3

TulisokibartExtension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06651281

Conditions

Crohn Disease

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Tulisokibart

Placebo to tulisokibart

Study Details

Brief summary:

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Conditions

Crohn Disease

Colitis, Ulcerative

Study ID

NCT06651281

Start date

Nov 25, 2024

Status verified date

May, 2026

Completion date

Dec 17, 2037

Anticipated

Primary completion date

Dec 17, 2037

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
A participant of childbearing potential (POCBP) is not pregnant and 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
A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

Exclusion Criteria:

Has prematurely discontinued study intervention in their parent study
Has received any protocol-specified prohibited medications during their parent study
Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Study Design

Enrollment

1380 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Low Dose Unblinded

Participants receive a low dose subcutaneous (SC) tulisokibart regimen.

experimental: Group 2: High Dose Unblinded

Participants receive a high dose SC tulisokibart regimen.

experimental: Group 3: High Dose Blinded

Participants receive a blinded high dose SC tulisokibart regimen.

experimental: Group 4: Low Dose Blinded

Participants receive a blinded low dose SC tulisokibart regimen.

Interventions

Tulisokibart

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

Placebo to tulisokibart

Placebo matching SC tulisokibart

Primary outcome measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 378 weeks ]
Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 364 weeks ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Connecticut Clinical Research Institute ( Site 0297)

Recruiting

Bristol, Connecticut, United States, 06010

Contacts

Study Coordinator

860-585-3000

St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Study Coordinator

734-418-7736

BVL Research - Kansas ( Site 0292)

Recruiting

Liberty, Missouri, United States, 64068

Contacts

Study Coordinator

785-217-6559

New York Gastroenterology Associates ( Site 0253)

Recruiting

New York, New York, United States, 10075

Contacts

Study Coordinator

212-369-2490

GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)

Recruiting

Garland, Texas, United States, 75044

Contacts

Study Coordinator

972-265-8201

GI Alliance - Lubbock ( Site 0288)

Recruiting

Lubbock, Texas, United States, 79410

Contacts

Study Coordinator

806-793-3141

Caprock Gastro Research ( Site 0293)

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Study Coordinator

808-239-1823

Southern Star Research Institute ( Site 0299)

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Study Coordinator

210-581-2812

GI Alliance - Southlake ( Site 0298)

Recruiting

Southlake, Texas, United States, 76092-9167

Contacts

Study Coordinator

817-424-1525

Tyler Research Institute ( Site 0294)

Recruiting

Tyler, Texas, United States, 75701

Contacts

Study Coordinator

903-630-6211

University of Virginia Health System ( Site 0291)

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Study Coordinator

434-243-3090

Washington Gastroenterology - Tacoma ( Site 0295)

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Study Coordinator

425-452-8547

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-05-19.