Santos Dumont

Researchers are evaluating mirikizumab in children and adolescents aged 2 to 17 years with Crohn's disease, including those with fistulizing disease and active inflammation in the colon, ileum, or both. This Phase 3 study aims to assess how well mirikizumab works, its safety, tolerability, and how it is absorbed in the body for pediatric participants who have moderately to severely active Crohn's disease and a history of inadequate response or intolerance to other treatments. Participants will be randomly assigned to receive mirikizumab either intravenously or by injection under the skin. The study consists of a 12-week induction period to start treatment, followed by a maintenance period lasting up to Week 52, and a safety follow-up period continuing for up to 16 weeks after treatment. The entire study will last about 74 weeks and may include up to 19 visits for treatment and assessments. During the study, participants will undergo evaluations including endoscopy to assess disease activity, clinical assessments using the Pediatric Crohn's Disease Activity Index (PCDAI), and monitoring for treatment response and remission at Weeks 12 and 52. Safety and tolerability will be closely followed throughout the study and during the safety follow-up. The main outcomes measured are the percentage of participants achieving clinical and endoscopic response over the study period.