clinical trial · NCT04844606
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Eli Lilly and Company·phase3·recruiting·n = 150
Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's DiseaseMirikizumabMirikizumab
brief 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.
started
May 26, 2021
primary completion
Dec 1, 2030
completion
Dec 1, 2030
last updated
Apr 17, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol