NCT07196748

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

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 882 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Icotrokinra	Icotrokinra tablet will be administered orally.
DRUG	Placebo	Placebo tablet will be administered orally.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-01-14
• Completion: 2032-01-13
• First posted: 2025-09-29
• Last updated: 2026-04-13

Locations

367 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study