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

Launched by ELI LILLY AND COMPANY · Apr 12, 2021

Keywords

ClinConnect Summary

The AMAZ trial is a clinical study looking at the long-term effects of a medication called mirikizumab in children and teenagers with ulcerative colitis (UC) or Crohn's disease (CD). This study is important because it aims to find out how well mirikizumab works over an extended period—about 172 weeks—and could involve up to 44 visits to the clinic. The goal is to help improve the health and quality of life for young patients dealing with these inflammatory bowel diseases.

To be eligible for this study, participants must have previously taken part in specific studies involving mirikizumab and still need treatment that could benefit them. They should be between 2 and 17 years old and must agree to certain safety measures, like contraception for young women. Throughout the trial, participants will be closely monitored to ensure their safety and the effectiveness of the treatment. It’s also important to note that individuals with certain serious health issues or who have had significant side effects from previous treatments may not be able to join this study. Overall, this trial aims to provide valuable information that could help improve treatment options for children with UC and CD.

Gender

ALL

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.