NCT04844606

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 2 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

Conditions

• Ulcerative Colitis
• Ulcerative Colitis Chronic
• Inflammatory Bowel Diseases
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Mirikizumab	Administered SC
DRUG	Mirikizumab	Administered IV

Timeline

• Start date: 2021-05-26
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2021-04-14
• Last updated: 2026-04-17

Locations

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

Regulatory

• FDA-regulated drug study