Summary

Eligibility
for people ages 2-19 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Sofia Verstraete (ucsf)
Headshot of Sofia Verstraete
Sofia Verstraete

Description

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.

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

Keywords

Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease, Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD, Colitis, Crohn Disease, Ulcer, Mirikizumab

Eligibility

Locations

  • UCSF Medical Center at Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Cook Children's Medical Center accepting new patients
    Fort Worth Texas 76104 United States

Lead Scientist at University of California Health

  • Sofia Verstraete (ucsf)
    Associate Professor, Pediatrics, School of Medicine. Authored (or co-authored) 29 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
ID
NCT04844606
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated