A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Jun 8, 2023
  • participants needed
    1044
  • sponsor
    Eli Lilly and Company
Updated on 25 November 2020
endoscopy
mirikizumab

Summary

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).

Details
Treatment Placebo, Mirikizumab
Clinical Study IdentifierNCT03524092
SponsorEli Lilly and Company
Last Modified on25 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug
Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry
If female, must meet the contraception requirements

Exclusion Criteria

Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086)
Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG
Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086)
Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086)
Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086)
Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug
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