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

Recruiting now · Phase 3

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT05509777

Run by

Eli Lilly and Company

People needed

90

Starts

2024-03-13

Expected to finish

2028-04-01

Last updated by the study team

2026-08-07

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)
• IWK Health Centre — Halifax, Canada (enrolling)
• Children's Center for Digestive Health Care, LLC — Atlanta, Georgia, United States (enrolling)
• Riley Childrens Hospital — Indianapolis, Indiana, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Integral Pesquisa e Ensino — Votuporanga, Brazil (enrolling)
• Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Columbia University Medical Center/New York Presbyterian — New York, New York, United States (enrolling)
• Childrens Medical Center — Dayton, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Cook Children's Medical Center — Fort Worth, Texas, United States (enrolling)
• University of Vermont Medical Center — Burlington, Vermont, United States (enrolling)
• NDI - Nucleo de Doenças Infecciosas — Santos Dumont, Brazil (enrolling)
• AKH - Medizinische Universtität Wien — Vienna, Austria (enrolling)
• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)
• Cliniques universitaires Saint-Luc — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Hospital PUC-CAMPINAS — Campinas, Brazil (enrolling)
• Hospital Pequeno Príncipe — Curitiba-PR, Brazil (enrolling)
• Hospital das Clínicas - UFG (Universidade Federal de Goiás) — Goiânia, Brazil (enrolling)
• Hospital de Clínicas de Porto Alegre — Porto Alegre, Brazil (enrolling)
• Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Brazil (enrolling)
• London Health Sciences Centre (LHSC) - Victoria Hospital — London, Canada (enrolling)

Full record on ClinicalTrials.gov

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