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Clinical Trials in Ireland / NCT03519945
Active, not recruiting Phase 3

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

NCT03519945 · tracked via the Priya Life Science Ireland tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2018-07-18
Last updated
2026-04-20

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Mirikizumab

Mirikizumab: Administered SC.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
* 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.

Primary outcome measure(s)

Trial sites (352)

FacilityCityRegionStatus
Digestive Health Specialists Dothan Alabama
Research Solutions of Arizona Litchfield Park Arizona
Valleywise Health Medical Center Phoenix Arizona
InSite Digestive Health Care Arcadia California
Care Access - Berkeley Berkeley California
Om Research LLC Lancaster California
California Medical Research Associates Northridge California
Inland Empire Clinical Trials, LLC Rialto California
Clinical Applications Laboratories, Inc. San Diego California
Direct Helpers Research Center Hialeah Florida
Encore Borland-Groover Clinical Research Jacksonville Florida
Wellness Clinical Research Miami Lakes Florida
AdventHealth Orlando Orlando Florida
Clintheory Healthcare Orlando Florida
Gastroenterology Associates of Pensacola, PA Pensacola Florida
Florida Medical Clinic LLC Zephyrhills Florida
Digestive Healthcare of Georgia Atlanta Georgia
Grand Teton Research Group Idaho Falls Idaho
NorthShore University HealthSystem - Evanston Hospital Evanston Illinois
Indiana University Health University Hospital Indianapolis Indiana
Cotton O'Neil Digestive Health Center Topeka Kansas
GI Alliance Research Baton Rouge Baton Rouge Louisiana
Delta Research Partners Monroe Louisiana
Nola Research Works, LLC New Orleans Louisiana
University of Michigan Ann Arbor Michigan
Clinical Research Institute of Michigan, LLC Chesterfield Michigan
Henry Ford Medical Center - Columbus Center Novi Michigan
West Michigan Clinical Research Center Wyoming Michigan
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic Plymouth Minnesota
Columbia University Medical Center New York New York
Clinical & Translational Research Center (CTRC) Chapel Hill North Carolina
Carolina Digestive Diseases and Endoscopy Center Greenville North Carolina
Care Access - Youngstown Poland Ohio
The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
Central Sooner Research - Oklahoma - Northwest 47th Street Oklahoma City Oklahoma
Care Access - Pottsville Pottsville Pennsylvania
Digestive Disease Associates Wyomissing Pennsylvania
Midwest Medical Care Sioux Falls South Dakota
GI Alliance Garland Texas
Biopharma Informatic, LLC Houston Texas

+ 312 more sites — see the full list on the official registry below.

On this site

📄 Omvoh (mirikizumab) drug profile →

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Other trials for the same condition

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) Active, not recruiting
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab Active, not recruiting
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis Recruiting
ABTECT - Maintenance Active, not recruiting
A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03519945 on ClinicalTrials.gov ↗ ← All trials in Ireland