Summary

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

Description

Summary

This study designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

Official Title

A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3

Keywords

Ulcerative Colitis Inflammatory Bowel Disease Colitis Colitis, Ulcerative Ulcer Mirikizumab

Eligibility

You can join if…

Open to people ages 18-80

  • Participants from Study AMAC (NCT02589665) or AMBG (NCT #:TBD) who have had at least one study drug administration and have not had early termination of study drug.
  • Female participants must agree to contraception requirements.

You CAN'T join if...

  • Participants must not have developed a new condition, including cancer in the originator study.
  • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
  • Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
  • Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • Om Research, LLC not yet accepting patients
    Lancaster California 93534 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT03519945
Phase
Phase 3
Study Type
Interventional
Last Updated