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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
NotablePrimary endpoints: details revised at 1 of 2 entriesTrial sites expanded: 14 → 17 locations · Eligibility criteria expanded, about 10 wordsShow 2 more changesShow less
Trial sites expanded: 14 → 17 locations
Eligibility criteria expanded, about 10 words
MinorTrial sites expanded: 10 → 14 locationsStart date changed from estimate of Aug 31, 2026 to Aug 18, 2026v10Show 1 more changeShow less
Start date changed from estimate of Aug 31, 2026 to Aug 18, 2026
MinorTrial sites expanded: 7 → 10 locationsv9
NotableStart date: Jun 30, 2026 to Aug 31, 2026Study sites: 5 to 7v8Show 1 more changeShow less
Study sites: 5 to 7
NotableStart date: May 29, 2026 to Jun 30, 2026Trial sites expanded: 2 → 5 locationsv7Show 1 more changeShow less
Trial sites expanded: 2 → 5 locations
NotableRecruitment openedStudy sites: 0 to 2v6Show 1 more changeShow less
Study sites: 0 to 2
MinorRe-verified, no change to tracked fieldsv5
MinorPrimary completion date: May 29, 2030 to May 31, 2030Completion date: May 29, 2031 to May 30, 2031v4Show 1 more changeShow less
Completion date: May 29, 2031 to May 30, 2031
Minor2 versionsRe-verified since Jan 21, 2026, no change to tracked fieldsv2-v3
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
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, 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).