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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Who can join
Ages 2 to 17 · All sexes
Full eligibility criteria
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.
About the 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.
What is being tested
- Mirikizumab (drug)
Sponsor: Eli Lilly and Company · Participants: 90 · Started: Mar 13, 2024
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT05509777
Locations in the U.S.
| California | Cedars Sinai Medical Center, Los Angeles (Not yet recruiting) |
| Connecticut | Connecticut Children's Medical Center, Hartford |
| Georgia | Children's Center for Digestive Health Care, LLC, Atlanta Emory University, Atlanta |
| Indiana | Riley Childrens Hospital, Indianapolis |
| Massachusetts | Boston Children's Hospital, Boston (Not yet recruiting) |
| New Jersey | Atlantic Children's Health--Pediatric Gastroenterology, Morristown (Not yet recruiting) |
| New York | Columbia University Medical Center/New York Presbyterian, New York Icahn School of Medicine at Mount Sinai, New York Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC), New York |
| Ohio | Childrens Medical Center, Dayton |
| Pennsylvania | Children's Hospital of Philadelphia, Philadelphia |
| Texas | Cook Children's Medical Center, Fort Worth |
| Vermont | University of Vermont Medical Center, Burlington |
| Washington | Seattle Children's Hospital, Seattle (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.