A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) (SHINE-1)

I6T-MC-AMBU -

This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab.

Trial Summary

Age Range
2 - 17 years
Conditions the trial is for
Ulcerative Colitis
What the trial is testing?
mirikizumab (LY3074828)
Could I receive a Placebo?
No
Enrollment Goal
26
Trial Dates
May 18, 2020 - Mar 15, 2023
How long will I be in the trial?
The study will last about 52 weeks and may include up to 17 visits.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must weigh >10 kg

  • Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications

  • Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment

  • Participants must have evidence of UC extending proximal to the rectum

  • Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

Participants Must Not:

  • Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis

  • Participants must not have had surgery to remove part of their colon

  • Participants must not have current evidence of toxic megacolon

  • Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening

  • Participants must not have inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)

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