Long-term study of mirikizumab in children with colitis or Crohn's disease
Tests mirikizumab long term in children with ulcerative colitis or Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Key facts
- Where
- Atlanta, Boston, Fairfax, Fort Worth, Hartford, New York, Philadelphia, San Francisco, St Louis, and Waltham, United StatesSee the 11 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 19 years old?
Source: NCT04844606, who can take part
Where in United States
- Children's Center for Digestive Health Care, LLCAtlanta, United StatesTaking people
- Emory University School of MedicineAtlanta, United StatesTaking people
- Boston Children's HospitalBoston, United StatesTaking people
- Pediatric Specialists Of VirginiaFairfax, United StatesNot yet recruiting
- Cook Children's Medical CenterFort Worth, United StatesTaking people
- Connecticut Children's Medical CenterHartford, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Children's Hospital of Philadelphia (CHOP)Philadelphia, United StatesNot yet recruiting
- UCSF Medical Center at Mission BaySan Francisco, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- Massachusetts General HospitalWaltham, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT04844606
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.