A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Recruiting now · Phase 3
Conditions studied: Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT04844606
- Run by
- Eli Lilly and Company
- People needed
- 150
- Starts
- 2021-05-26
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 2 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Sheffield Children's Hospital — Sheffield, United Kingdom (enrolling)
- Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Poland (enrolling)
- Kyungpook National University Chilgok Hospital — Deagu, South Korea (enrolling)
- Hospital Universitari i Politecnic La Fe — Valencia, Spain (enrolling)
- Yitzhak Shamir Medical Center — Ẕerifin, Israel (enrolling)
- Twoja Przychodnia SCM — Szczecin, Poland (enrolling)
- Dr. von Haunersches Kinderspital — Munich, Germany (enrolling)
- Centrum Zdrowia Dziecka w Warszawie — Warsaw, Poland (enrolling)
- Centro Hospitalar de Sao Joao - Hospital de Sao Joao — Porto, Portugal (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Schneider Children's Medical Center — Petah Tikva, Israel (enrolling)
- Institute of Science Tokyo Hospital — Bunkyō, Japan (enrolling)
- Juntendo University Hospital — Bunkyō City, Japan (enrolling)
- Tsujinaka Hospital - Kashiwanoha — Kashiwa, Japan (enrolling)
- Shaare Zedek Medical Center — Jerusalem, Israel (enrolling)
- National Center for Child Health and Development — Tokyo, Japan (enrolling)
- Yokohama City University Medical Center — Yokohama, Japan (enrolling)
- Azienda Ospedaliera Universitaria Meyer IRCCS — Florence, Italy (enrolling)
- Hadassah Medical Center — Jerusalem, Israel (enrolling)
- Ospedale dei Bambini Vittore Buzzi — Milan, Italy (enrolling)
- Centrum Medyczne Oporów — Wroclaw, Poland (enrolling)
- AOU Policlinico Umberto I — Roma, Italy (enrolling)
- Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland (enrolling)
- UCSF Medical Center at Mission Bay — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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