This study is not yet accepting patients

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

a study on Inflammatory Bowel Disease

Summary

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

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Keywords

Ulcerative Colitis Interleukin-23 (IL-23) antibody IL-23p19 Colitis Ulcer Colitis, Ulcerative Mirikizumab

Eligibility

You can join if…

Open to people ages 18-80

  • Diagnosis of UC for at least 3 months prior to baseline.
  • Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
  • Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
  • If female, must meet the contraception requirements.

You CAN'T join if...

  • Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
  • Participants with a previous colectomy.
  • Participants with current evidence of toxic megacolon.
  • Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Locations

  • UC San Diego Altman Clinical and Translational Research Inst not yet accepting patients
    La Jolla California 92037 United States
  • Clinical Applications Laboratories, Inc. not yet accepting patients
    San Diego California 92103 United States
  • The Geneva Foundation not yet accepting patients
    San Diego California 92134 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT03518086
Phase
Phase 3
Study Type
Interventional
Last Updated
May 30, 2018