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

In plain English

What this trial is testing

This study is testing Mirikizumab (a drug) and Mirikizumab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis, Ulcerative Colitis Chronic and Inflammatory Bowel Diseases.

It is open-label: participants know what they are receiving.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 2 to 19
• Any sex

Some of the main requirements, copied from the record:

• 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…
• 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.

There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 150 participants are expected to take part.
• The study has 7 groups.
• Start date: 2021-05-26.
• Main results expected around 2030-12 (estimate from the record).
• 69 study sites listed (39 marked recruiting) in Austria, Belgium, Brazil, Canada and Germany and 11 more countries.

Groups in this study

• Mirikizumab Dose 1 for UC (listed as: experimental group)
• Mirikizumab Dose 2 for UC (listed as: experimental group)
• Mirikizumab Dose 3 for UC (listed as: experimental group)
• Mirikizumab Dose 4 for CD (listed as: experimental group)
• Mirikizumab Dose 5 for CD (listed as: experimental group)
• Mirikizumab Dose 6 for CD (listed as: experimental group)

Main thing being measured

• Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission (Week 52)
• Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission (Week 52)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.