A Master Protocol for a Phase 3, Open-label, Long-term Extension Study of Mirikizumab in Children and Adolescents with Moderate-to-Severe Ulcerative Colitis or Crohns Disease

What this Trial Is About

Researchers are evaluating the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis UC or Crohns disease CD. This Phase 3, open-label, multicenter study aims to understand how well mirikizumab works over an extended period, lasting about 172 weeks with up to 44 visits. The study is sponsored by Eli Lilly and Company and includes participants aged 2 to 19 years who have previously been treated with mirikizumab in earlier studies. Participants receive mirikizumab administered subcutaneously under the skin, with dosing based on their weight. There are multiple doses, numbered Dose 1 through Dose 6, with an additional intravenous rescue dose available if a participant loses response to the treatment. The study follows an open-label design without randomization or masking. Throughout the study, participants undergo regular assessments including clinical remission and response measured by the Modified Mayo Score for UC and the Pediatric Crohns Disease Activity Index for CD at Week 52. Other outcomes include endoscopic remission and response, corticosteroid-free remission, and changes in inflammatory markers. Safety is monitored continuously, and additional treatment may be offered during a continued access period. The total participation time can last over three years, with extensive follow-up visits and evaluations.

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)