Not currently recruiting at UCSD

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by William Sandborn
Headshot of William Sandborn
William Sandborn

Description

Summary

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

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, Mirikizumab

Eligibility

You can join if…

Open to people ages 18-80

  • Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) 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 92037 United States
  • Clinical Applications Laboratories, Inc. completed
    San Diego California 92103 United States
  • Research Associates of South Florida accepting new patients
    Miami Florida 33156 United States
  • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod accepting new patients
    Nizhny Novgorod Nizhegorodskaya Oblast' 603140 Russian Federation
  • Medical Center SibNovoMed completed
    Novosibirsk Novosibirskaya Oblast' 630008 Russian Federation
  • Research Institute of Physiology and Fundamental Medicine completed
    Novosibirsk Novosibirskaya Oblast' 630117 Russian Federation
  • Ultramed completed
    Omsk Omskaya Oblast' 644024 Russian Federation
  • Rostov State Medical University completed
    Rostov-on-Don Rostovskaya Oblast' 344022 Russian Federation
  • North-Western State Medical University named after I.I.Mechnikov completed
    Saint - Petersburg Sankt-Peterburg 191015 Russian Federation
  • Clinical Hospital "RZhD-Medicine" accepting new patients
    Saint Petersburg Sankt-Peterburg 195271 Russian Federation

Lead Scientist at UCSD

  • William Sandborn
    Recall Faculty, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 937 research publications

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
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
ID
NCT03519945
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1063 study participants
Last Updated