NCT05509777

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Mirikizumab	Administered IV or SC

Timeline

• Start date: 2024-03-13
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2022-08-22
• Last updated: 2026-03-27

Locations

81 sites across 16 countries: United States, Austria, Belgium, Brazil, Canada, France, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study