NCT06819878

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

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 Crohn's Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (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 induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Conditions

• Moderately to Severely Active Crohns Disease

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: 2025-03-17
• Primary completion: 2028-12-31
• Completion: 2033-12-31
• First posted: 2025-02-11
• Last updated: 2026-04-02

Locations

355 sites across 38 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Dominican Republic, France, Germany, Guatemala, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Panama, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Taiwan, Thailand, United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated drug study