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
StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
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Record History

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  1. Trial sites expanded: 22 → 26 locations
    • Eligibility criteria expanded, about 10 words
  2. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints revised (17)
    v15
  3. Trial sites expanded: 15 → 22 locationsv14
  4. Trial sites expanded: 12 → 15 locationsv13
  5. Study Status, Contacts/Locations, Referencesv12
  6. Trial sites expanded: 9 → 12 locationsv11
  7. Trial sites expanded: 6 → 9 locationsv10
  8. Study sites: 4 to 6
    • Start date: Mar 31, 2026 to Apr 15, 2026
    v9
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    v8
  10. 6 versions Re-verified since Sep 26, 2025, no change to tracked fieldsv2-v7
  11. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07158242
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Moderately to Severely Active Ulcerative Colitis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov