NCT06589986

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Conditions

• Moderately to Severely Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Afimkibart	Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
DRUG	Placebo	Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Timeline

• Start date: 2024-09-17
• Primary completion: 2027-01-30
• Completion: 2031-01-30
• First posted: 2024-09-19
• Last updated: 2026-03-19

Locations

229 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, Spain, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study