A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Sponsored by Eli Lilly and Company
About this study
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.
Where this study is enrolling (7)
- I'm interested
Emory University School of Medicine
Atlanta, Georgia
- Call 617-355-6058
Boston Children's Hospital
Boston, Massachusetts
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 314-454-6173
Washington University School of Medicine
St Louis, Missouri
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 212-241-5415
Icahn School of Medicine at Mount Sinai
New York, New York
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 800-879-2467
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Show all 7 locations
- Call 682-885-1990
Cook Children's Medical Center
Fort Worth, Texas
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
- Call 703-876-2788
Pediatric Specialists of Virginia
Fairfax, Virginia
This research site can be reached directly by phone. Call to ask about this study.
Create a free account to get updates on similar Clinical Trials for your conditions.
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.