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Taking people in United StatesPhase 3

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.

Key facts

Who runs it
Eli Lilly and Company
Where
Atlanta, Boston, Fairfax, Fort Worth, Hartford, New York, Philadelphia, San Francisco, St Louis, and Waltham, United StatesSee the 11 sitesAlso in 15 other countries, 58 sites
Registry title
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Status
Recruiting
Phase
Phase 3
People taking part
150 people, planned
Started
26 May 2021
Expected to end
Dec 2030
Type of study
Interventional, 7 groups
Treatments tested
  • Mirikizumab
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with ulcerative colitis or Crohn's disease who took part in an earlier mirikizumab study and may benefit from more treatment.

Age
2 Years to 19 Years
Sex
All sexes can join.
Disease stage
Ulcerative colitis or Crohn's disease that was moderate to severe.
Earlier treatment
Must have been in one of the earlier mirikizumab studies and be still on the study drug at the last visit.

Main reasons for not taking part

  • A serious side effect in the earlier study that makes more mirikizumab an unreasonable risk
  • Stopped the study drug in the earlier study so that restarting would be an unacceptable risk
  • Unstable or uncontrolled illness that could affect safety
  • Adenomatous polyps that have not been removed
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

Also in 15 other countries, 58 sites

  • Children's Center for Digestive Health Care, LLCAtlanta, United StatesContact: Jeffery Lewis (principal investigator)Taking people
  • Emory University School of MedicineAtlanta, United StatesContact: subra kugathasan (principal investigator)Taking people
  • Boston Children's HospitalBoston, United StatesContact: Athos Bousvaros (principal investigator)Taking people
  • Pediatric Specialists Of VirginiaFairfax, United StatesContact: Peter Lee (principal investigator)Not yet recruiting
  • Cook Children's Medical CenterFort Worth, United StatesContact: Clifton Huang (principal investigator)Taking people
  • Connecticut Children's Medical CenterHartford, United StatesContact: Jeffrey Hyams (principal investigator)Taking people
  • Icahn School of Medicine at Mount SinaiNew York, United StatesContact: David Dunkin (principal investigator)Taking people
  • Children's Hospital of Philadelphia (CHOP)Philadelphia, United StatesContact: Arthur Kastl (principal investigator)Not yet recruiting
  • UCSF Medical Center at Mission BaySan Francisco, United StatesContact: Sofia Verstraete (principal investigator)Taking people
  • Washington University School of MedicineSt Louis, United StatesContact: Charles Samson (principal investigator)Taking people
  • Massachusetts General HospitalWaltham, United StatesContact: Jess Kaplan (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 7 groups in the trial

  • Mirikizumab Dose 1 for UCTreatment being tested

    Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.

    Treatment: Mirikizumab

  • Mirikizumab Dose 2 for UCTreatment being tested

    Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Treatment: Mirikizumab

  • Mirikizumab Dose 3 for UCTreatment being tested

    Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Treatment: Mirikizumab

  • Mirikizumab Dose 4 for CDTreatment being tested

    Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Treatment: Mirikizumab

  • Mirikizumab Dose 5 for CDTreatment being tested

    Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Treatment: Mirikizumab

  • Mirikizumab Dose 6 for CDTreatment being tested

    Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.

    Treatment: Mirikizumab

  • Mirikizumab Dose 7 for UC or CDTreatment being tested

    Intravenous (IV) rescue dosing, if response is lost.

    Treatment: Mirikizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Long-term study of mirikizumab in children with colitis or Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04844606, who can take part
Record updated
7 October 2026