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Evaluating Mirikizumab for Children with Crohn's Disease

A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

Phase 3 Interventional Eli Lilly and Company · NCT05509777

This study is testing a new medication called mirikizumab to see if it helps children with Crohn's disease feel better and manage their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment90 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsmirikizumab
Locations81 sites (Los Angeles, California and 80 other locations)
Trial IDNCT05509777 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and tolerability of mirikizumab in pediatric participants diagnosed with Crohn's disease. Participants will be screened and randomly assigned to receive either mirikizumab or another intervention. The study includes a 12-week induction period followed by a maintenance phase lasting up to 52 weeks, with a total duration of approximately 74 weeks and up to 19 visits. The study aims to assess how well mirikizumab is absorbed in the body and its overall effectiveness in treating active Crohn's disease in children.

Who should consider this trial

Good fit: Ideal candidates are children with a confirmed diagnosis of moderately to severely active Crohn's disease who have not responded adequately to previous treatments.

Not a fit: Patients with complications of Crohn's disease that may require surgery or those with certain severe manifestations of the disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing Crohn's disease in pediatric patients.

How similar studies have performed: Other studies have shown promise with similar biologic therapies for Crohn's disease, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 80 other locations

+31 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseInflammatory Bowel Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.