Status:
RECRUITING
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ulcerative Colitis
Ulcerative Colitis Chronic
Eligibility:
All Genders
2-19 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
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.
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04844606
Start Date
May 26 2021
End Date
December 1 2030
Last Update
December 24 2025
Active Locations (59)
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1
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
2
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
4
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States, 30342