A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
Phase 3 – large-scale trial before approval
Conditions:
Ulcerative Colitis
Sponsor: Eli Lilly and Company
trial.available_in:
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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.
Who can participate
* 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.
Interventions
Mirikizumab
DRUG
Locations
352
Argentina (5)
Mautalen Salud e Investigación
Buenos Aires
CER medical Institute
Quilmes
Fundacion Estudios Clinicos
Rosario
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman
C.I.C.E. 9 de Julio
San Miguel de Tucumán
Australia (7)
Royal Adelaide Hospital
Adelaide
Box Hill Hospital
Box Hill
Mater Misericordiae Limited
Brisbane
Princess Alexandra Hospital
Brisbane
Coastal Digestive Health
Maroochydore
St Vincent's Hospital
Melbourne
The Royal Melbourne Hospital
Parkville
Austria (3)
Medizinische Universitaet Innsbruck
Innsbruck
Uniklinikum Salzburg
Salzburg
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna
Belgium (3)
UZ Gent
Ghent
UZ Leuven
Leuven
Centre Hospitalier de Wallonie Picarde - Site Notre Dame
Tournai
Canada (9)
CISSS de la Monteregie-Centre
Greenfield Park
Victoria Hospital
London
University Hospital - London Health Sciences Centre
London
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal
Montreal General Hospital
Montreal
Fraser Clinical Trials Inc
New Westminster
Vancouver General Hospital
Vancouver
GIRI GI Research Institute - Vancouver
Vancouver
PerCuro Clinical Research
Victoria
China (33)
Xiangya Hospital Central South University
Changsha
Changzhou No.2 People's Hospital
Changzhou
West China Hospital of Sichuan University
Chengdu
The First Affiliated Hospital Of Fujian Medical University
Fuzhou
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou
Hainan General Hospital
Haikou
The First Affiliated Hospital, Zhejiang University
Hangzhou
Sir Run Run Shaw Hospital
Hangzhou
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui Provincial Hospital
Hefei
Center-Jilin Center Hospital
Jilin
Shandong Provincial Hospital
Jinan
Qilu Hospital of Shandong University
Jinan
First Affiliated Hospital of Kunming Medical University
Kunming
The First People's Hospital of Yunnan Province
Kunming
Liaocheng People's Hospital
Liaocheng
The First Affiliated Hospital of Nanchang University
Nanchang
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing
Zhongda Hospital Southeast University
Nanjing
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing
The Affiliated Hospital of Qingdao University
Qingdao
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai
Shengjing Hospital of China Medical University
Shenyang
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang
Taian City Central Hospital
Taian
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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