Evaluating Mirikizumab Treatment by IV or Subcutaneous Injection in Children and Teens with Crohns Disease

What this Trial Is About

Researchers are evaluating mirikizumab for children and teenagers aged 2 to 17 years with moderately to severely active Crohns disease, including fistulizing Crohns disease with active inflammation in the colon or ileum. The study aims to assess the treatments effectiveness, safety, tolerability, and how well it is absorbed in the body. Participants must have a history of inadequate response or intolerance to other Crohns disease medications and will be randomly assigned to receive mirikizumab or another intervention. The treatment involves receiving mirikizumab either intravenously IV or subcutaneously SC, with dosing based on the participants weight in three different weight groups over 40 kg, 20 to 40 kg, and 9 to 20 kg. The study includes a 12-week induction period, followed by a maintenance phase lasting until Week 52. After treatment, there is a safety follow-up period lasting up to 16 weeks. The entire study spans about 74 weeks and may include up to 19 visits. Participants will undergo assessments including clinical response evaluations by the Pediatric Crohns Disease Activity Index PCDAI, endoscopic assessments using the Simple Endoscopic Score for Crohns Disease SES-CD, and laboratory tests such as C-reactive protein and fecal calprotectin levels. Pharmacokinetic studies will measure how the drug is cleared and distributed in the body. Safety monitoring continues during the follow-up period to track any adverse events or treatment tolerability throughout the study duration.

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease