Clinical Trial

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

Study acronym: SIBERITE-PEDS
Recruiting Phase 3
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Summary
This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
Protocol Amendment History 3 changes
notable Trial sites expanded: 7 -> 10 locations 2026-08-11
notable Trial sites expanded: 2 -> 5 locations 2026-06-13
critical Recruitment opened 2026-05-16
Trial Details
NCT Number NCT07298421
Lead Sponsor Hoffmann-La Roche
Conditions Moderately to Severely Active Crohns Disease
Enrollment 100 participants
Start Date 2026-08-31
Primary Completion 2030-05-31 (estimated)
Study Completion 2031-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-10