Skip to content
Bored Studies
RecruitingPhase 3

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

Merck Sharp & Dohme LLC · NCT06651281

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1380
US sites recruiting
12
Study start
November 25, 2024
Record last updated
October 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Tulisokibart; Placebo to tulisokibart

Conditions: Crohn Disease; Colitis, Ulcerative

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Connecticut Clinical Research Institute ( Site 0297)

    Bristol, CT 06010

    Site contact: Study Coordinator · 860-585-3000

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

    Ypsilanti, MI 48197

    Site contact: Study Coordinator · 734-418-7736

  • BVL Research - Kansas ( Site 0292)

    Liberty, MO 64068

    Site contact: Study Coordinator · 816-222-4241

  • New York Gastroenterology Associates ( Site 0253)

    New York, NY 10075

    Site contact: Study Coordinator · 212-369-2490

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

    Garland, TX 75044

    Site contact: Study Coordinator · 972-265-8201

  • GI Alliance - Lubbock ( Site 0288)

    Lubbock, TX 79410

    Site contact: Study Coordinator · 806-793-3141

  • Caprock Gastro Research ( Site 0293)

    Lubbock, TX 79424

    Site contact: Study Coordinator · 808-239-1823

  • Southern Star Research Institute ( Site 0299)

    San Antonio, TX 78229

    Site contact: Study Coordinator · 210-581-2812

  • GI Alliance - Southlake ( Site 0298)

    Southlake, TX 76092-9167

    Site contact: Study Coordinator · 817-424-1525

  • Tyler Research Institute ( Site 0294)

    Tyler, TX 75701

    Site contact: Study Coordinator · 903-630-6211

  • University of Virginia Health System ( Site 0291)

    Charlottesville, VA 22908

    Site contact: Study Coordinator · 434-243-3090

  • Washington Gastroenterology - Tacoma ( Site 0295)

    Tacoma, WA 98405

    Site contact: Study Coordinator · 425-452-8547

Study contacts (from the official record)

  • Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
Extension Study of Long-term Safety and Efficacy of Tulisokibart… (NCT06651281) | Bored Studies