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
A successful Phase 3 trial could provide a new treatment option specifically studied in children with moderate‑to‑severe Crohn's disease, addressing a pediatric population often underrepresented in trials.
Pediatric patients with moderate‑to‑severe Crohn's disease and their caregivers, pediatric gastroenterologists, and researchers involved in pediatric IBD drug development.
What To Know
This is a Phase 3 trial testing Afimkibart (RO7790121), an investigational therapy, as induction and maintenance treatment for children (ages 2–17) with moderately to severely active Crohn's disease. The study will assess clinical remission and endoscopic response at Week 52 and is recruiting at multiple international pediatric centers.
This is a registered interventional Phase 3, double‑blind, treat‑through study enrolling about 100 children. Afimkibart is given both IV and SC in the study arms. Eligible children must have active moderate–severe disease by PCDAI and endoscopy and have had inadequate response or intolerance to prior conventional or advanced therapies.
The primary outcomes are clinical remission (PCDAI) and endoscopic response at Week 52. The trial excludes children with certain complications (for example current abscess, symptomatic strictures, fulminant colitis, toxic megacolon) and some other diagnoses (eg, ulcerative colitis, primary sclerosing cholangitis).
Locations include sites in Australia, Taiwan, and Thailand. This is a trial record describing a planned/ongoing study — it does not report results. Eligibility criteria, interventions, and outcomes are those listed on the registry.
This entry is a clinicaltrials.gov record (Phase 3, recruiting). It describes study design and planned outcomes but does not contain efficacy or safety results. Afimkibart is investigational (RO7790121) and not yet an approved IBD therapy.
