An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

I6T-MC-AMAN -

The purpose of this study is to evaluate the safety and efficacy of mirikizumab inparticipants with moderately to severely active ulcerative colitis (UC) who have had aninadequate response to, loss of response, or who cannot tolerate conventional or biologic therapy for UC.

Trial Summary

Age Range
18 - 80 years
Conditions the trial is for
Ulcerative Colitis
What the trial is testing?
Mirikizumab, Placebo
Could I receive a Placebo?
Yes
Enrollment Goal
1281
Trial Dates
Jun 18, 2018 - May 15, 2024
How long will I be in the trial?
The study will last about 12 weeks and may include up to 6 visits.
Trial Phase
III

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

  • Participants must have moderately or severely active ulcerative colitis at the start of the study

  • Participants must have had unsatisfactory results with or were unable to take other therapies for UC

  • Participants who are female must meet birth control requirements in order to participate in the study

Participants Must Not:

  • Participants must not have other types of inflammatory bowel disease, such as Crohn's disease or indeterminate colitis (also known as inflammatory bowel disease-unclassified)

  • Participants must not have had surgery in the past in order to remove part of the colon

  • Participants must not have certain complications of ulcerative colitis. One of these is called toxic megacolon. This is a condition where the colon is abnormally enlarged or dilated, often requiring surgical treatment

  • Participants must not have received certain types of medications for inflammatory diseases in the past. The study doctor can determine if you have received these when they speak with you at the screening visit

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