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RECRUITINGPHASE3

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

A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis

NCT06651281•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (37)

Connecticut Clinical Research Institute ( Site 0297)

Bristol, Connecticut, United States

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

Ypsilanti, Michigan, United States

BVL Research - Kansas ( Site 0292)

Liberty, Missouri, United States

New York Gastroenterology Associates ( Site 0253)

New York, New York, United States

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

Garland, Texas, United States

GI Alliance - Lubbock ( Site 0288)

Lubbock, Texas, United States

Caprock Gastro Research ( Site 0293)

Lubbock, Texas, United States

Southern Star Research Institute ( Site 0299)

San Antonio, Texas, United States

GI Alliance - Southlake ( Site 0298)

Southlake, Texas, United States

Tyler Research Institute ( Site 0294)

Tyler, Texas, United States

Key Dates

Start Date

November 25, 2024

Primary Completion Date

December 17, 2037

Completion Date

December 17, 2037

Last Updated

December 26, 2025

Enrollment

1,380

ESTIMATED participants

Conditions

Crohn DiseaseColitis, Ulcerative

Interventions

Tulisokibart

DRUG

Placebo to tulisokibart

DRUG

Contacts

Toll Free Number

CONTACT

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

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

NCT05076175

Colitis, Ulcerative

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RECRUITING

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study