Clinical Trial

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Study acronym: ICONIC-UC
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
Protocol Amendment History 4 changes
notable Trial sites expanded: 393 -> 398 locations 2026-07-07
notable Trial sites expanded: 385 -> 393 locations 2026-06-06
notable Trial sites expanded: 367 -> 385 locations 2026-05-09
notable Trial sites expanded: 301 -> 367 locations 2026-04-14
Trial Details
NCT Number NCT07196748
Lead Sponsor Janssen Research & Development, LLC
Conditions Colitis, Ulcerative
Enrollment 882 participants
Start Date 2025-10-01
Primary Completion 2028-01-14 (estimated)
Study Completion 2032-01-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-31