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

Phase 3Active Not RecruitingNCT03519945

Eli Lilly and Company1,058 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,058

Conditions

Ulcerative Colitis

Interventions

MirikizumabDRUG

Administered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

* Inclusion Criteria * 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. * Exclusion Criteria * 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 (352)

Outcomes

Primary Outcomes

Percentage of Participants in Clinical Remission

Clinical remission based on the modified Mayo Score (MMS).

Time frame: Week 52

Secondary Outcomes

Percentage of Participants in Endoscopic Remission

Endoscopic remission based on the MMS Endoscopic Subscore (ES).

Time frame: Week 52

Percentage of Participants in Corticosteroid-free Remission

Participants in corticosteroid-free remission.

Time frame: Week 52

Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52

Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.

Time frame: Week 52

Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score

Health Related Quality of Life based on IBDQ score.

Time frame: Baseline to Week 52

UC Symptoms: Numeric Rating Score

UC symptoms based on numeric rating score.

Time frame: Week 160

Percentage of Participants Who are Hospitalized Due to UC

Participants who are hospitalized due to UC.

Time frame: Baseline to Week 160

Percentage of Participants Who Undergo UC Surgeries Including Colectomy

Participants who undergo UC surgeries including colectomy.

Data from ClinicalTrials.gov

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Digestive Health Specialists

Dothan, Alabama, United States

Research Solutions of Arizona

Litchfield Park, Arizona, United States

Valleywise Health Medical Center

Phoenix, Arizona, United States

InSite Digestive Health Care

Arcadia, California, United States

Care Access - Berkeley

Berkeley, California, United States

Om Research LLC

Lancaster, California, United States

California Medical Research Associates

Northridge, California, United States

Inland Empire Clinical Trials, LLC

Rialto, California, United States

Clinical Applications Laboratories, Inc.

San Diego, California, United States

Direct Helpers Research Center

Hialeah, Florida, United States

...and 342 more locations