ACTIVE_NOT_RECRUITING

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

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Conditions

Ulcerative ColitisInflammatory Bowel Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2018-07-18
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03519945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Digestive Health Specialists
Dothan, Alabama, 36305
United States
Research Solutions of Arizona
Litchfield Park, Arizona, 85340
United States
Valleywise Health Medical Center
Phoenix, Arizona, 85008
United States
InSite Digestive Health Care
Arcadia, California, 91006
United States
Care Access - Berkeley
Berkeley, California, 94705
United States
University of California San Diego
La Jolla, California, 92037
United States
Om Research LLC
Lancaster, California, 93534
United States
California Medical Research Associates
Northridge, California, 91324
United States
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
United States
Clinical Applications Laboratories, Inc.
San Diego, California, 92103
United States
Direct Helpers Research Center
Hialeah, Florida, 33012
United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
United States
Wellness Clinical Research
Miami Lakes, Florida, 33016
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Clintheory Healthcare
Orlando, Florida, 32819
United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503
United States
Florida Medical Clinic LLC
Zephyrhills, Florida, 33542-7505
United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327
United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404
United States
NorthShore University HealthSystem - Evanston Hospital
Evanston, Illinois, 60201
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606
United States
GI Alliance Research Baton Rouge
Baton Rouge, Louisiana, 70809
United States
Delta Research Partners
Monroe, Louisiana, 71201
United States
Nola Research Works, LLC
New Orleans, Louisiana, 70125
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
United States
Henry Ford Medical Center - Columbus Center
Novi, Michigan, 48377
United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
United States
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
Plymouth, Minnesota, 55446
United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021
United States
Columbia University Medical Center
New York, New York, 10032
United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599-7080
United States
Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina, 27834
United States
Care Access - Youngstown
Poland, Ohio, 44514
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5008
United States
Central Sooner Research - Oklahoma - Northwest 47th Street
Oklahoma City, Oklahoma, 73118
United States
Care Access - Pottsville
Pottsville, Pennsylvania, 17901
United States
Digestive Disease Associates
Wyomissing, Pennsylvania, 19610
United States
Midwest Medical Care
Sioux Falls, South Dakota, 57108
United States
GI Alliance
Garland, Texas, 75044
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Biopharma Informatic, LLC
Houston, Texas, 77084
United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
United States
Southern Star Research Institute
San Antonio, Texas, 78229
United States
GI Alliance
Southlake, Texas, 76092
United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092
United States
Care Access-Ogden
Ogden, Utah, 84403
United States
Care Access Research LLC - Salt Lake City
Salt Lake City, Utah, 84124
United States
Carilion Clinic
Roanoke, Virginia, 24014
United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-18
Study Completion Date2027-12

Study Record Updates

Study Start Date2018-07-18
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Inflammatory Bowel Disease

Additional Relevant MeSH Terms

  • Ulcerative Colitis