A Phase III Randomized Double-Blind Multi-Center Study to Evaluate the Safety and Effectiveness of Afimkibart for Induction and Maintenance Therapy in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Afimkibart (also known as RO7790121) in children aged 2 to 17 years who have moderately to severely active Crohn's Disease. This phase III, randomized, double-blind study involves multiple centers and aims to study both induction and maintenance therapy with Afimkibart. The trial addresses a need for better treatment options in pediatric Crohn's Disease, particularly for those who have had inadequate responses or intolerance to other therapies. Participants will receive Afimkibart initially through an intravenous (IV) infusion followed by subcutaneous (SC) injections. There are two experimental doses being studied, and the treatment is given throughout the study period to assess its impact on disease activity. The study includes a treat-through design, meaning participants continue treatment during the entire study duration to evaluate long-term effects. During the trial, participants will have assessments including the Pediatric Crohn's Disease Activity Index (PCDAI) and endoscopic evaluations to monitor disease remission and response at weeks 12 and 52. Researchers will also track safety by monitoring adverse events and measuring drug levels in the blood for up to about 5.5 years. Other measures include fecal biomarkers and mucosal inflammation scores. Participants can expect regular visits for clinical evaluations, laboratory tests, and endoscopic procedures as part of the study follow-up.

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