Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSD UCSF
Dates
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 Colitis, Ulcerative Ulcer 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

  • University of California - San Diego in progress, not accepting new patients
    La Jolla California 92093 United States
  • UCSF Medical Center at Mission Bay in progress, not accepting new patients
    San Francisco California 94158 United States
  • Valley View Internal Medicine completed
    Garden Grove California 92843 United States
  • Clinical Applications Laboratories, Inc. in progress, not accepting new patients
    San Diego California 92103 United States
  • California Medical Research Group in progress, not accepting new patients
    Northridge California 91324 United States
  • Care Access Research in progress, not accepting new patients
    Berkeley California 94705 United States
  • Gastroenterology Associates completed
    Pasadena California 91105 United States
  • Valley Gastroenterology Cnslts in progress, not accepting new patients
    Arcadia California 91006 United States
  • Citrus Valley Health Partners completed
    Covina California 91722 United States
  • Catalina Research Institute, LLC completed
    Montclair California 91763 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
ID
NCT03518086
Phase
Phase 3 research study
Study Type
Interventional
Participants
At least 1281 people participating
Last Updated