NCT07196722

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,092 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Icotrokinra	Icotrokinra will be administered orally, daily.
DRUG	Placebo	Matching placebo will be administered orally, daily.

Timeline

• Start date: 2025-10-03
• Primary completion: 2028-09-19
• Completion: 2032-10-06
• First posted: 2025-09-29
• Last updated: 2026-03-12

Locations

324 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