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
estimated completion
Principal Investigator
by Sofia G Verstraete (ucsf)
Headshot of Sofia G Verstraete
Sofia G Verstraete

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.

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 Colitis Colitis, Ulcerative Ulcer Mirikizumab

Eligibility

You can join if…

Open to people ages 2-19

  • Participants from originating studies (I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) who should, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
  • Participants from prior studies who have had at least one study drug administration and have not had early termination of study drug.
  • Female participants must agree to contraception requirements.

You CAN'T join if...

  • Participants must not have developed a new condition, including cancer in the originator study.
  • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study.
  • Participants must not have received surgery for UC or CD as applicable in the originator study or are likely to require surgery for treatment of UC or CD during the study.
  • Participants must not require parenteral nutrition delivered by central vein and/or central venous catheter for venous access.

Locations

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

Lead Scientist at University of California Health

  • Sofia G Verstraete (ucsf)
    Associate Professor, Pediatrics, School of Medicine. Authored (or co-authored) 21 research publications

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 185 study participants
Last Updated