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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
StatusRecruiting
PhasePhase 3
Started2025-05-12
View on ClinicalTrials.gov ↗
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).

Amendment history 6 changes detected by DataLookout

2026-09-01
Trial sites expanded: 196 → 199 locations
2026-08-05
Trial sites expanded: 187 → 196 locations
2026-07-07
Trial sites expanded: 178 → 187 locations
2026-06-09
Trial sites expanded: 173 → 178 locations
2026-05-08
Trial sites expanded: 167 → 173 locations
2026-04-14
Trial sites expanded: 162 → 167 locations
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 2026-08-31