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

  • STATUS
    Recruiting
  • End date
    Aug 27, 2023
  • participants needed
    1044
  • sponsor
    Eli Lilly and Company
Updated on 13 June 2021
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
Fakultni nemocnice Kralovske Vinohrady (0.0 mi away) Contact
+903 other location
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
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Placebo, Mirikizumab
Clinical Study IdentifierNCT03524092
SponsorEli Lilly and Company
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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