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

RecruitingPhase 3

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

Who can join

Ages 2 to 19 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
* Female participants must agree to contraception requirements.

Exclusion Criteria:

* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
* Participants must not have adenomatous polyps that have not been removed.
* Participants must not be pregnant or breastfeeding.

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 150 · Started: May 26, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04844606

Locations in the U.S.

CaliforniaUCSF Medical Center at Mission Bay, San Francisco
ConnecticutConnecticut Children's Medical Center, Hartford
GeorgiaChildren's Center for Digestive Health Care, LLC, Atlanta
Emory University School of Medicine, Atlanta
MassachusettsBoston Children's Hospital, Boston
Massachusetts General Hospital, Waltham
MissouriWashington University School of Medicine, St Louis
New YorkIcahn School of Medicine at Mount Sinai, New York
PennsylvaniaChildren's Hospital of Philadelphia (CHOP), Philadelphia (Not yet recruiting)
TexasCook Children's Medical Center, Fort Worth
VirginiaPediatric Specialists of Virginia, Fairfax (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.