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Study details
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Icotrokinra Trial for Ulcerative Colitis

Janssen Research & Development, LLC
NCT IDNCT07196748ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

882

Study length

about 6.3 years

Ages

12+

Locations

47 sites in AZ, CA, CO +17

What this study is about

Researchers are testing whether icotrokinra, a medication, can help people with moderately to severely active ulcerative colitis. The trial will last 2295 days and involve approximately 882 participants.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Icotrokinra
  • 2.Take Placebo

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
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

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

Endpoints

Secondary: DB Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), DB Induction Study: Percentage of Adult Participants with Fatigue Response at Week I-12, DB Induction Study: Percentage of Adult Participants with No Abdominal Pain at Week I-12, DB Maintenance Study: Percentage of Adult Participants with AEs and SAEs, DB Maintenance Study: Percentage of Adult Participants with Disease Clearance at Week M-40, DB Maintenance Study: Percentage of Adult Participants with Fatigue Response at Week M-40, DB Maintenance Study: Percentage of Adult Participants with No Abdominal Pain at Week M-40, OL Induction Phase: Percentage of Adolescent Participants with AEs and SAEs

Body systems

Gastroenterology