Clinical Trial

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

Study acronym: SIBERITE-2
Recruiting Phase 3
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Summary
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Protocol Amendment History 4 changes
notable Trial sites expanded: 178 -> 187 locations 2026-07-07
notable Trial sites expanded: 173 -> 178 locations 2026-06-09
notable Trial sites expanded: 167 -> 173 locations 2026-05-08
notable Trial sites expanded: 162 -> 167 locations 2026-04-14
Trial Details
NCT Number NCT06819891
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions Moderately to Severely Active Crohns Disease
Enrollment 425 participants
Start Date 2025-05-12
Primary Completion 2028-12-31 (estimated)
Study Completion 2033-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-06