For Healthcare Professionals

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

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About the study

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
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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. Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
  2. Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
  3. If female, must meet the contraception requirements.

EXCLUSION CRITERIA

  1. Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
  2. 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.
  3. Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
  4. 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).
  5. Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
  6. Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
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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

1177

Est. Completion Date

Apr 2026

Treatment type

Interventional


Sponsor

Eli Lilly and Company

ClinicalTrials.gov identifier

NCT03524092

Study number

I6T-MC-AMBG

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