This study is in progress, not accepting new patients

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

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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).

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

Keywords

Ulcerative Colitis, Interleukin-23 (IL-23), IL-23p19, Inflammatory Bowel Disease, Colitis, Ulcer, Mirikizumab, Mirikizumab SC, Mirikizumab IV, Extended Induction: Induction Nonresponders - 300mg Miri IV

Eligibility

You can join if…

Open to people ages 18-80

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF Medical Center at Mission Bay
    San Francisco California 94158 United States
  • Care Access Research
    Berkeley California 94705 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT03524092
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1177 people participating
Last Updated