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

• Status: Recruiting
• Trial end date: 2027-09-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Mirikizumab

Criteria

Inclusion Criteria:

• Participants from originating studies (I6T-MC-AMBU [NCT04004611]) 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.

Exclusion Criteria:

• 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 in the originator study or are likely to require surgery for treatment of UC during the study.

• Participants must not require parenteral nutrition delivered by central vein and/or central venous catheter for venous access.