Summary

for people ages 18-80 (full criteria)
at La Jolla, 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 Ulcer Colitis, Ulcerative 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 Diego not yet accepting patients
    La Jolla California 92093 United States
  • Inland Empire Liver Foundation accepting new patients
    Rialto California 92377 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