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

Last updated: March 26, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Placebo to tulisokibart

Tulisokibart

Clinical Study ID

NCT06651281
7240-011
2024-513533-20
U1111-1306-6970
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CDor UC

  • The investigator determines that the participant derives clinical benefit fromcontinued study intervention based upon clinical evaluations performed during theirparent study

  • A participant assigned female sex at birth is not breastfeeding during the studyintervention period and for at least 14 weeks after the last dose of studyintervention

  • A participant of childbearing potential (POCBP) is not pregnant and has a negativehighly sensitive pregnancy test (urine or serum) as required by local regulationswithin 24 hours (for a urine test) or 72 hours (for a serum test) before the firstdose of study intervention

  • A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginalintercourse abstinence as their preferred and usual lifestyle (abstinent on along-term and persistent basis)

Exclusion

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 itsexcipients

Study Design

Total Participants: 1380
Treatment Group(s): 2
Primary Treatment: Placebo to tulisokibart
Phase: 3
Study Start date:
November 25, 2024
Estimated Completion Date:
December 17, 2037

Connect with a study center

  • Medrise Sp. z o.o. ( Site 2200)

    Lublin, Lubelskie 20-582
    Poland

    Active - Recruiting

  • Vivamed Sp. z o.o. ( Site 2201)

    Warsawa, Mazowieckie 03-580
    Poland

    Active - Recruiting

  • Centrum Zdrowia MDM ( Site 2202)

    Warszawa, Mazowieckie 00-189
    Poland

    Active - Recruiting

  • Vita Longa Sp. Zoo ( Site 2213)

    Katowice, Slaskie 40-748
    Poland

    Active - Recruiting

  • Sonomed Sp. z o. o. ( Site 2203)

    Szczecin, Zachodniopomorskie 71-685
    Poland

    Active - Recruiting

  • Connecticut Clinical Research Institute ( Site 0297)

    Bristol, Connecticut 06010
    United States

    Active - Recruiting

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

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • BVL Research - Kansas ( Site 0292)

    Liberty, Missouri 64068
    United States

    Active - Recruiting

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

    Garland, Texas 75044
    United States

    Active - Recruiting

  • Caprock Gastro Research ( Site 0293)

    Lubbock, Texas 79424
    United States

    Active - Recruiting

  • GI Alliance - Lubbock ( Site 0288)

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • Southern Star Research Institute ( Site 0299)

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • GI Alliance - Southlake ( Site 0298)

    Southlake, Texas 76092-9167
    United States

    Active - Recruiting

  • Tyler Research Institute ( Site 0294)

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Washington Gastroenterology - Tacoma ( Site 0295)

    Tacoma, Washington 98405
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.