for people ages 2-19 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Sofia G Verstraete
Photo of Sofia G Verstraete
Sofia G Verstraete



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


Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease Pediatric Ulcerative Colitis Pediatric Crohn's Disease Pediatric UC Pediatric CD Crohn Disease Colitis Colitis, Ulcerative Ulcer Mirikizumab Mirikizumab Dose 1 for UC Mirikizumab Dose 2 for UC Mirikizumab Dose 3 for UC


You can join if…

Open to people ages 2-19

  • Participants from originating studies (I6T-MC-AMBU [NCT04004611]) who should, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
  • Participants from prior studies who have had at least one study drug administration and have not had early termination of study drug.
  • Female participants must agree to contraception requirements.

You CAN'T join if...

  • Participants must not have developed a new condition, including cancer in the originator study.
  • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study.
  • Participants must not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
  • Participants must not require parenteral nutrition delivered by central vein and/or central venous catheter for venous access.


  • 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 UCSF

  • Sofia G Verstraete
    Assistant Professor, Pediatrics. Authored (or co-authored) 18 research publications.


accepting new patients
Start Date
Completion Date
Eli Lilly and Company
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Phase 3
Study Type
Last Updated