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Phase 3Recruiting

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

Sponsored by Eli Lilly and Company

About this study

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.

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Where this study is enrolling (12)

  • Cedars Sinai Medical Center

    Los Angeles, California

    Call 310-248-8516

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  • Connecticut Children's Medical Center

    Hartford, Connecticut

    Call 860-837-5591

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  • Emory University

    Atlanta, Georgia

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  • Riley Childrens Hospital

    Indianapolis, Indiana

    Call 317-274-5858

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  • Boston Children's Hospital

    Boston, Massachusetts

    Call 617-355-6058

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Show all 12 locations

  • Atlantic Children's Health--Pediatric Gastroenterology

    Morristown, New Jersey

    Call 973-971-6489

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  • Icahn School of Medicine at Mount Sinai

    New York, New York

    Call 212-659-9443

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  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

    New York, New York

    Call 646-962-7162

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  • Childrens Medical Center

    Dayton, Ohio

    Call 937-641-5605

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  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania

    Call 800-879-2467

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  • University of Vermont Medical Center

    Burlington, Vermont

    Call 802-656-9402

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  • Seattle Children's Hospital

    Seattle, Washington

    Call 206-987-1293

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Who can participate

Inclusion criteria

  • ✓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.

Exclusion criteria

  • ✕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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.