AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 2 Years - 19 YearsAllEli Lilly and Company
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • Mirikizumab
  • Mirikizumab
๐Ÿ“

Where

69 sites
UCSF Medical Center at Mission Bay
San Francisco, United States
Connecticut Children's Medical Center
Hartford, United States
Emory University School of Medicine
Atlanta, United States
Children's Center for Digestive Health Care, LLC
Atlanta, United States
Boston Children's Hospital
Boston, United States
Massachusetts General Hospital
Waltham, United States
Washington University School of Medicine
St Louis, United States
Icahn School of Medicine at Mount Sinai
New York, United States

โ€ฆand 61 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy