Clinical Trial

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

Study acronym: AMETRINE-PEDS
Recruiting Phase 3
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Summary
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
Protocol Amendment History 3 changes
notable Trial sites expanded: 12 -> 15 locations 2026-07-17
notable Trial sites expanded: 9 -> 12 locations 2026-05-23
notable Trial sites expanded: 6 -> 9 locations 2026-04-24
Trial Details
NCT Number NCT07158242
Lead Sponsor Hoffmann-La Roche
Conditions Moderately to Severely Active Ulcerative Colitis
Enrollment 100 participants
Start Date 2026-04-15
Primary Completion 2030-03-31 (estimated)
Study Completion 2031-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16