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Long-term safety and effectiveness of tulisokibart for Crohn's disease and ulcerative colitis

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

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06651281

This study is testing if the medication tulisokibart is safe and effective for people with moderate to severe Crohn's disease and ulcerative colitis over a longer period of time.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1380 (estimated)
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations37 sites (Bristol, Connecticut and 36 other locations)
Trial IDNCT06651281 on ClinicalTrials.gov

What this trial studies

This extension study aims to evaluate the long-term safety and efficacy of tulisokibart, a medication for treating active, moderate to severe Crohn's disease and ulcerative colitis. Participants who have previously taken tulisokibart in earlier studies will be invited to continue receiving the treatment to assess its ongoing benefits and tolerability. The study will monitor participants over time to gather data on the medication's safety profile and effectiveness in managing their conditions.

Who should consider this trial

Good fit: Ideal candidates are individuals who have previously participated in a Phase 2 or Phase 3 study of tulisokibart and are deemed to benefit from continued treatment.

Not a fit: Patients who have prematurely discontinued the study intervention or do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of Crohn's disease and ulcerative colitis, potentially improving patient outcomes.

How similar studies have performed: Other studies involving similar medications for Crohn's disease and ulcerative colitis have shown promising results, indicating that this approach is built on a foundation of prior success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Bristol, Connecticut and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn DiseaseColitis, Ulcerative
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.