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

a study on Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease

Summary

Eligibility
for people ages 2-19 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Sofia Verstraete (ucsf)

Description

Summary

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.

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

Keywords

Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease, Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD, Crohn Disease, mirikizumab

Eligibility

You can join if…

Open to people ages 2-19

  • 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 CAN'T join 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.

Locations

  • UCSF Medical Center at Mission Bay accepting new patients
    San Francisco 5391959 California 5332921 94158 United States
  • Cook Children's Medical Center accepting new patients
    Fort Worth 4691930 Texas 4736286 76104 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
ID
NCT04844606
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated