For Healthcare Professionals

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

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About the study

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Diagnosis of UC for at least 3 months prior to baseline.
  2. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
  3. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
  4. If female, must meet the contraception requirements.

EXCLUSION CRITERIA

  1. Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
  2. Participants with a previous colectomy.
  3. Participants with current evidence of toxic megacolon.
  4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-317-615-4559Email iconEmail Study Center

Study’s details


Contition

Ulcerative Colitis

Age (in years)

18 - 80

Phase

Phase 3

Participants needed

1281

Est. Completion Date

Mar 2024

Treatment type

Interventional


Sponsor

Eli Lilly and Company

ClinicalTrials.gov identifier

NCT03518086

Study number

I6T-MC-AMAN

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