Study Condition(s): Ulcerative Colitis

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

Study Alias: AMBG

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT03524092 {{ currentLocaleObject.registryAnchorText }}

Withdrawn Not yet recruiting

Study Purpose

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).

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18 years
80 years

Time Commitment

The study will last about 40 weeks and may include up to 11 visits.
  • Participants must have completed Study AMAN (NCT03518086), received study drug, and without early termination of study drug
  • Participants must be willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry
  • Female participants must meet the contraception (birth control) requirements
  • Participants must not have had surgery to remove part of the bowel or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086) and must not be likely to require surgery for the treatment of UC during study AMBG
  • Participants must not have evidence of abnormal cells in the colon or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086)
  • Participants must not be 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 must not initiate a new medication that was not allowed during the induction study AMAN (NCT03518086)
  • Participants must not have certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug

Where to Participate

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