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

What this study is about

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.

Who can join (things the study team will check)

✅ You may be able to join if…

• Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
• Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).
• Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
• Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

🚫 You may not be able to join if…

• Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
• Participants must not have an abscess.
• Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Where this trial is running

• Cedars Sinai Medical Center, Los Angeles, California, United States
• Connecticut Children's Medical Center, Hartford, Connecticut, United States
• Emory University, Atlanta, Georgia, United States
• Children's Center for Digestive Health Care, LLC, Atlanta, Georgia, United States
• Riley Childrens Hospital, Indianapolis, Indiana, United States
• Boston Children's Hospital, Boston, Massachusetts, United States
• Atlantic Children's Health--Pediatric Gastroenterology, Morristown, New Jersey, United States
• Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC), New York, New York, United States
• Icahn School of Medicine at Mount Sinai, New York, New York, United States
• Columbia University Medical Center/New York Presbyterian, New York, New York, United States
• Childrens Medical Center, Dayton, Ohio, United States
• Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

+ 69 more sites.

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05509777.