A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Eli Lilly and Company · NCT05509777
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 2–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 90
- US sites recruiting
- 11
- Study start
- March 13, 2024
- Record last updated
- October 7, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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.
Being studied: Mirikizumab
Conditions: Crohn's Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Connecticut Children's Medical Center
Hartford, CT 06032
Site contact: 860-837-5591
Emory University
Atlanta, GA 30322
Site contact: 404-727-4542
Children's Center for Digestive Health Care, LLC
Atlanta, GA 30342
Site contact: Jeffery Lewis
Riley Childrens Hospital
Indianapolis, IN 46202
Site contact: 317-274-5858
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, NY 10021-5663
Site contact: 646-962-7162
Icahn School of Medicine at Mount Sinai
New York, NY 10029
Site contact: 212-659-9443
Columbia University Medical Center/New York Presbyterian
New York, NY 10032
Site contact: Joseph Picoraro
Childrens Medical Center
Dayton, OH 45404
Site contact: 937-641-5605
Children's Hospital of Philadelphia
Philadelphia, PA 19146
Site contact: 973-971-7747
Cook Children's Medical Center
Fort Worth, TX 76104
Site contact: Clifton Huang
University of Vermont Medical Center
Burlington, VT 05401
Site contact: 802-656-9402
Study contacts (from the official record)
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
- Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com