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



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:4/5/2019
Start Date:July 18, 2018
End Date:August 23, 2023
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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Trial Summary
Trial Overview
Inclusion Criteria

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

This study designed to evaluate the long-term efficacy and safety of mirikizumab in
participants with moderately to severely active ulcerative colitis (UC).


- Inclusion Criteria

- Participants from Study AMAC (NCT02589665) or AMBG (NCT #:TBD) 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.
We found this trial at
13
sites
The University of California, San Diego
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: William J Sandborn
Phone: 858-657-5284
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Borland-Groover Clinic
4800 Belfort Rd # 2
Jacksonville, Florida 32256
Principal Investigator: Mark R Fleisher
Phone: 904-398-3262
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Jacksonville, FL
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Peter D Higgins
Phone: 734-647-2964
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Clinical Research Institute of Michigan,
Chesterfield, Michigan 48098
Principal Investigator: Ronald P Fogel
Phone: 586-598-3329
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Chesterfield, MI
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Mautalen Salud e Investigación - Servicio de Endocrinología
Ciudad Autonoma De Buenos Air,
Principal Investigator: Emiliano Tron
Phone: 541145143410
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Ciudad Autonoma De Buenos Air,
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Wellness Clinical Research, LLC
Hialeah Gardens, Florida 33016
Principal Investigator: Lucky Flores
Phone: 786-483-7856
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Hialeah Gardens, FL
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Nature Coast Clinical Research
Inverness, Florida 34452
Principal Investigator: Paul A Hellstern
Phone: 352-341-2100
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Inverness, FL
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Delta Research Partners, LLC
Monroe, Louisiana 71201
Principal Investigator: Bal Raj Bhandari
Phone: 318-283-2177
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from
Monroe, LA
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Columbia University Medical Center
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Simon Lichtiger
Phone: 212-831-4900
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446
Principal Investigator: Robert P McCabe
Phone: 612-870-5599
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Plymouth, MN
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Inland Empire Liver Foundation
Rialto, California 92377
Principal Investigator: Zeid Kayali
Phone: 909-883-2999
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Rialto, CA
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Care Access Research - Salt Lake City
1045 East 3900 South
Salt Lake City, Utah 84124
Principal Investigator: Peder J Pedersen
Phone: 801-893-1788
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Salt Lake City, UT
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Gastroenterology Research Of San Antonio
San Antonio, Texas 78229
Principal Investigator: Nicholas P Martinez
Phone: 210-615-3848
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San Antonio, TX
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