Clinical Trial

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

Study acronym: SIBERITE-1
Recruiting Phase 3
View on ClinicalTrials.gov →
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).
Protocol Amendment History 3 changes
notable Trial sites expanded: 364 -> 372 locations 2026-07-03
notable Trial sites expanded: 355 -> 362 locations 2026-05-05
notable Trial sites expanded: 344 -> 355 locations 2026-04-03
Trial Details
NCT Number NCT06819878
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions Moderately to Severely Active Crohns Disease
Enrollment 600 participants
Start Date 2025-03-17
Primary Completion 2028-12-31 (estimated)
Study Completion 2033-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-02