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Study details
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Extension Study of Long-term Safety and Efficacy of Tulisokibart

Merck Sharp & Dohme LLC
NCT IDNCT06651281ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

1,380

Study length

about 13 years

Ages

All ages

Locations

12 sites in CT, MI, MO +4

What this study is about

Researchers are testing the safety and effectiveness of tulisokibart over a long period in people with Crohn's disease or ulcerative colitis. The trial is for people who previously received tulisokibart in other studies.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Placebo to tulisokibart
  • 2.Take Tulisokibart

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Number of Participants Who Discontinue Study Treatment Due to an AE, Number of Participants Who Experience an Adverse Event (AE)

Secondary: Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score

Body systems

Gastroenterology