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

Name: A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis — clinical trial record (NCT07158242)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: AMETRINE-PEDS

StatusRecruiting

PhasePhase 3

SponsorHoffmann-La Roche

Started2026-04-15

View on ClinicalTrials.gov ↗

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).

Amendment history 4 changes detected by DataLookout

2026-08-15

Trial sites expanded: 15 → 22 locations

2026-07-17

Trial sites expanded: 12 → 15 locations

2026-05-23

Trial sites expanded: 9 → 12 locations

2026-04-24

Trial sites expanded: 6 → 9 locations

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	2026-08-14