RightFit
RecruitingPhase 3

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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 19 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 44 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last about 172 weeks and may include up to 44 visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well mirikizumab works over time in children with ulcerative colitis or Crohn’s disease, which cause swelling in the digestive tract. It is for children from certain earlier studies of this drug. The study lasts about 172 weeks, with up to 44 visits, and more treatment may be available afterward.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must come from one of these earlier studies: I6T-MC-AMBA, I6T-MC-AMBU, I6T-MC-AMAM, or I6T-MC-AMAY.
  • The study doctor must think more treatment with mirikizumab could help.
  • Must have finished the tests and steps at the last visit of the earlier study and still be taking the study drug.
  • Female participants must agree to the birth control rules.

Who can't join

  • Had a health problem during the earlier study or before this study that would make more mirikizumab treatment too risky.
  • Stopped the drug for a time or for good in the earlier study, and restarting it would be too risky.
  • Have an illness that is not stable or well controlled and could affect safety.
  • Taking part would be unsafe for any other reason or make the study results hard to understand.
  • Have adenomatous polyps—growths that may turn into cancer—that have not been removed.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (11)

CA

CT

  • Connecticut Children's Medical Center · Hartford, CT 06106Jeffrey Hyams · Principal investigatorMore trials in Hartford

GA

  • Emory University School of Medicine · Atlanta, GA 30322subra kugathasan · Principal investigatorMore trials in Atlanta
  • Children's Center for Digestive Health Care, LLC · Atlanta, GA 30342Jeffery Lewis · Principal investigatorMore trials in Atlanta

MA

MO

NY

PA

TX

VA