Clinical trial NCT03519945: A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 1063
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: * 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 outcomes:
measure: Percentage of Participants in Clinical Remission
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants in Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants in Corticosteroid-free Remission
timeFrame: Week 52
measure: Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52
timeFrame: Week 52
measure: Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: Baseline to Week 52
measure: UC Symptoms: Numeric Rating Score
timeFrame: Week 160
measure: Percentage of Participants Who are Hospitalized Due to UC
timeFrame: Baseline to Week 160
measure: Percentage of Participants Who Undergo UC Surgeries Including Colectomy
timeFrame: Baseline to Week 160
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Valleywise Health Medical Center
state: Arizona
city: Arcadia
country: United States
facility: InSite Digestive Health Care
state: California
city: Berkeley
country: United States
facility: Care Access - Berkeley
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Northridge
country: United States
facility: California Medical Research Associates
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Jacksonville
country: United States
facility: Encore Borland-Groover Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Clintheory Healthcare
state: Florida
city: Pensacola
country: United States
facility: Gastroenterology Associates of Pensacola, PA
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic LLC
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group
state: Idaho
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Health Center
state: Kansas
city: Baton Rouge
country: United States
facility: GI Alliance Research Baton Rouge
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: New Orleans
country: United States
facility: Nola Research Works, LLC
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Novi
country: United States
facility: Henry Ford Medical Center - Columbus Center
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Plymouth
country: United States
facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
state: Minnesota
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Clinical & Translational Research Center (CTRC)
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases and Endoscopy Center
state: North Carolina
city: Poland
country: United States
facility: Care Access - Youngstown
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Central Sooner Research - Oklahoma - Northwest 47th Street
state: Oklahoma
city: Pottsville
country: United States
facility: Care Access - Pottsville
state: Pennsylvania
city: Wyomissing
country: United States
facility: Digestive Disease Associates
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Midwest Medical Care
state: South Dakota
city: Garland
country: United States
facility: GI Alliance
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute
state: Texas
city: Southlake
country: United States
facility: GI Alliance
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Ogden
country: United States
facility: Care Access-Ogden
state: Utah
city: Salt Lake City
country: United States
facility: Care Access Research LLC - Salt Lake City
state: Utah
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Tacoma
country: United States
facility: Washington Gastroenterology - Tacoma
state: Washington
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Quilmes
country: Argentina
facility: CER medical Institute
state: Ciudad Autónoma De Buenos Aires
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: C.I.C.E. 9 de Julio
state: Tucumán
city: Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Maroochydore
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
state: Tirol
city: Vienna
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
state: Wien
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame
state: Wallonne, Région
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI GI Research Institute - Vancouver
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research
state: British Columbia
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
city: London
country: Canada
facility: University Hospital - London Health Sciences Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Second Afilliated Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou Shi
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Zhuzhou
country: China
facility: ZhuZhou Central Hospital
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Jilin
country: China
facility: Center-Jilin Center Hospital
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Taian
country: China
facility: Taian City Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University school of medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Brno
country: Czechia
facility: Vojenská Nemocnice Brno
state: Brno-město
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK
state: Hradec Králové
city: Olomouc
country: Czechia
facility: MUDr. Gregar, s.r.o.
state: Olomoucký Kraj
city: Pilsen
country: Czechia
facility: A-Shine
state: Plzeň-město
city: Olomouc
country: Czechia
facility: PreventaMed
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 8
country: Czechia
facility: MEDIENDO
city: Praha 9
country: Czechia
facility: ISCARE klinicke centrum
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
state: Hovedstaden
city: Køge
country: Denmark
facility: Sjællands Universitetshospital Køge
state: Sjælland
city: Nyborg
country: Denmark
facility: Sygehusenheden Nyborg
state: Syddanmark
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
state: Alpes-Maritimes
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil (NHC)
state: Alsace
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque
state: Aquitaine
city: Chambray Les Tours
country: France
facility: CHRU Troussau
state: Centre
city: Neuilly-sur-Seine
country: France
facility: Centres Médico Chirurgicaux - Clinique Ambroise Paré
state: Hauts-de-Seine
city: Montpellier
country: France
facility: Chu Saint Eloi
state: Languedoc-Roussillon
city: Saint Priest En Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
state: Loire
city: Vandoeuvre lès Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
state: Lorraine
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille
state: Nord
city: Pau
country: France
facility: Centre Hospitalier de Pau
state: Pyrénées-Atlantiques
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhône
city: Amiens
country: France
facility: CHU d'Amiens-Picardie - Hôpital Sud
state: Somme
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Tbilisi
country: Georgia
facility: LLC ARENSIA Exploratory Medicine
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Ludwigshafen
country: Germany
facility: Haus der Gesundheit
state: Rheinland-Pfalz
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: Universitätsklinikum Halle
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede
city: Brandenburg
country: Germany
facility: Städtisches Klinikum Brandenburg
city: Hamburg
country: Germany
facility: HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Győr
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz
state: Győr-Moson-Sopron
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház
state: Pest
city: Szekszárd
country: Hungary
facility: CLINFAN Szolgáltató Kft
state: Tolna
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Eszak-budai Szent Janos Centrumkorhaz
city: Békéscsaba
country: Hungary
facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
city: Miskolc
country: Hungary
facility: Endomedix Diagnosztikai Központ - Miskolc
city: Ahmedabad
country: India
facility: Apollo Hospitals Ahmedabad
state: Gujarat
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
state: Gujarat
city: Surat
country: India
facility: Nirmal Hospital
state: Gujarat
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospitals
state: Karnataka
city: Nagpur
country: India
facility: Midas Multispeciality Hospital Pvt.Ltd.
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic
state: Maharashtra
city: Wardha
country: India
facility: Acharya Vinoba Bhave Rural Hospital
state: Maharashtra
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Jaipur
country: India
facility: SR Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Hyderabad
country: India
facility: Owaisi Hospital and Research Center
state: Telangana
city: Secunderabad
country: India
facility: Gandhi Hospital
state: Telangana
city: Noida
country: India
facility: Fortis Hospital
state: Uttar Pradesh
city: Dublin
country: Ireland
facility: Beaumont Hospital, Dublin
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Nahariya
country: Israel
facility: Galilee Medical Center
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Roma
country: Italy
facility: Fondazione Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: Lazio
city: Rozzano
country: Italy
facility: Humanitas
state: Lombardia
city: Rho
country: Italy
facility: Ospedale Di Circolo
state: Milano
city: Rome
country: Italy
facility: Ospedale Sandro Pertini
state: Roma
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
state: Toscana
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
city: Genova
country: Italy
facility: Ospedale San Martino
city: Torino
country: Italy
facility: Ospedale Mauriziano
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki National Hospital
state: Aomori
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Kitakyusyu-shi
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukoka
city: Kurume-shi
country: Japan
facility: Hidaka Coloproctology Clinic
state: Fukuoka-Ken
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Takasaki
country: Japan
facility: National Hospital Organization Takasaki General Medical Centar
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa City Hospital
state: Hokkaido
city: Chuo-ku, Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Aoyama Clinic GI Endoscopy & IBD Center
state: Hyogo-Ken
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Higashiibaraki
country: Japan
facility: Mito Medical Center
state: Ibaraki
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Kamakura
country: Japan
facility: Ofuna Central Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kawasaki Municipal Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Matsushima Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Sendai
country: Japan
facility: Takagi Clinic - Sendai
state: Miyagi
city: Nagaoka
country: Japan
facility: Nagaoka Chuo General Hospital
state: Niigata
city: Oita-shi
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
state: Oita-Ken
city: Fujiidera
country: Japan
facility: Sai Gastroenterologist Proctology
state: Osaka
city: Kumagaya-shi
country: Japan
facility: Kumagaya General Hospital
state: Saitama-Ken
city: Hamamatsu
country: Japan
facility: Matsuaikai Matsuda Hospital
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyō
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Showa University Koto Toyosu Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Kagoshima
country: Japan
facility: Sameshima Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization Kyoto Medical Center
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Infusion Clinic
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
city: Saga
country: Japan
facility: Saga-Ken Medical Center Koseikan
city: Saitama
country: Japan
facility: Tokitokai Tokito Clinic Coloproctology Center
city: Tokyo
country: Japan
facility: Tokyo Yamate Medical Center
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital
state: Kang-won-do
city: Gyeongsan-si
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
state: Kyǒngsangbuk-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Pusan-Kwangyǒkshi
city: Haeundae-gu
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St. Mary's Hospital
state: Taejǒn-Kwangyǒkshi
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
state: Rīga
city: Riga
country: Latvia
facility: RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia
state: Rīga
city: Riga
country: Latvia
facility: Digestive Diseases Center "Gastro"
city: Klaipėda
country: Lithuania
facility: Viesoji Istaiga Klaipedos Miesto Poliklinika
state: Klaipėdos Miestas
city: Panevezys
country: Lithuania
facility: Respublikine Panevezio ligonine
state: Panevėžio Apskritis
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas
city: Klaipeda
country: Lithuania
facility: Republic Hospital of Klaipeda
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Alor Star
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kota Bahru
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Cheras, Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan University Kebangsaan Malaysia
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
city: Selangor
country: Malaysia
facility: Hospital Serdang
city: Culiacán
country: Mexico
facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon
city: Chisinau
country: Moldova, Republic of
facility: Republican Clinical Hospital
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
state: Noord-Brabant
city: Uden
country: Netherlands
facility: Ziekenhuis Bernhoven
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
state: Noord-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Wroclaw
country: Poland
facility: Planetmed
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: LexMedica
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne "Medis" Manermed
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Gastromed
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
state: Lubelskie
city: Lublin
country: Poland
facility: ZOZ Gastromed
state: Lubelskie
city: Zamosc
country: Poland
facility: ETG Zamość
state: Lubelskie
city: Warsaw
country: Poland
facility: Vivamed Sp. z o.o.
state: Mazowieckie
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
state: Mazowieckie
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
state: Małopolskie
city: Krakow
country: Poland
facility: Topolowa Medicenter
state: Małopolskie
city: Nowy Targ
country: Poland
facility: Medicenter Nowy Targ
state: Małopolskie
city: Wadowice
country: Poland
facility: NZOZ Formed
state: Małopolskie
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
state: Małopolskie
city: Rzeszow
country: Poland
facility: Centrum Medyczne LUX MED - Rzeszow
state: Podkarpackie
city: Sopot
country: Poland
facility: Endoskopia Sp. z.o.o.
state: Pomorskie
city: Elblag
country: Poland
facility: Szpital Miejski im. Jana Pawła II w Elblagu
state: Warmińsko-mazurskie
city: Olsztyn
country: Poland
facility: Wojewódzki Szpital Specjalistyczny w Olsztynie
state: Warmińsko-mazurskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: SONOMED Centrum Medyczne
state: Zachodniopomorskie
city: Bedzin
country: Poland
facility: Promedica Dental Clinic
state: Śląskie
city: Katowice
country: Poland
facility: All-Medicus
state: Śląskie
city: Oradea
country: Romania
facility: Spitalul Pelican
state: Bihor
city: Bucharest
country: Romania
facility: Spitalul de Oncologie Monza
state: București
city: Bucuresti
country: Romania
facility: S.C. Centrul Medical Medicum SRL
state: București
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
state: București
city: Bucuresti
country: Romania
facility: CCBR Clinical Research
state: București
city: Barnaul
country: Russian Federation
facility: Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
state: Altayskiy Kray
city: Irkutsk
country: Russian Federation
facility: Scientific Centre of Reconstructive and Restorative Surgery
state: Irkutskaya Oblast'
city: Petrozavodsk
country: Russian Federation
facility: Karelia Republican Hospital V.A. Baranova
state: Kareliya, Respublika
city: Kemerovo
country: Russian Federation
facility: SIH Kemerovo Regional Clinical Hosptial
state: Kemerovskaya Oblast'
city: Saint Petersburg
country: Russian Federation
facility: City Mariinskaya Hospital
state: Leningradskaya Oblast'
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Hospital N.A. Semashko
state: Nizhegorodskaya Oblast'
city: Novosibirsk
country: Russian Federation
facility: Medical Center SibNovoMed
state: Novosibirskaya Oblast'
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Physiology and Fundamental Medicine
state: Novosibirskaya Oblast'
city: Omsk
country: Russian Federation
facility: Ultramed
state: Omskaya Oblast'
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
state: Rostovskaya Oblast'
city: Saint - Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I.I.Mechnikov
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Scientific research center ECO-security
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of Saint Petersburg
state: Sankt-Peterburg
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University
state: Stavropol'skiy Kray
city: Ekaterinburg
country: Russian Federation
facility: LLC MA New Hospital
state: Sverdlovskaya Oblast'
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
state: Tatarstan, Respublika
city: Izhevsk
country: Russian Federation
facility: Alliance Biomedical URAL Group
state: Udmurtskaya Respublika
city: Yaroslavl
country: Russian Federation
facility: SHI of Yaroslavl Region Clinical Hospital #8
state: Yaroslavskaya Oblast'
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
state: Beograd
city: Belgrade
country: Serbia
facility: University Medical Center "Bezanijska kosa"
state: Beograd
city: Sombor
country: Serbia
facility: Regional Hospital Dr Radivoj Simonovic Sombor
state: Vojvodina
city: Sremska Mitrovica
country: Serbia
facility: Sremska Mitrovica Health Centre
state: Vojvodina
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic"
state: Vojvodina
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
state: Šumadijski Okrug
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
state: Bratislavský Kraj
city: Nitra
country: Slovakia
facility: KM Management
state: Nitriansky Kraj
city: Prešov
country: Slovakia
facility: Gastro
state: Prešovský Kraj
city: Vranov N. Toplou
country: Slovakia
facility: Endomed, s.r.o.
state: Prešovský Kraj
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
state: Girona [Gerona]
city: Las Palmas De GC
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Las Palmas
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Sagunto
country: Spain
facility: Hospital de Sagunto y C.E.
state: València
city: Alicante
country: Spain
facility: Instituto de Ciencias Médicas
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger, Seibold & Partner
state: Berne
city: St.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
state: Sankt Gallen
city: Berne
country: Switzerland
facility: Inselspital Bern
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bornova
country: Turkey
facility: Ege University Medicine of Faculty
state: İzmir
city: Antalya
country: Turkey
facility: Antalya Egitim ve Arastırma Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi
city: Mersin
country: Turkey
facility: Mersin University
city: Ivano-Frankivsk
country: Ukraine
facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: City Clinical Hospital No. 2
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: L.T. Mala National Institute of Therapy of NAMS of Ukraine
state: Kharkivska Oblast
city: Kherson
country: Ukraine
facility: Kherson City Clinical Hospital
state: Khersonska Oblast
city: Kropyvnytskyi
country: Ukraine
facility: Private Enterprise Private Manufacturing Company Acinus
state: Kirovohradska Oblast
city: Kiev
country: Ukraine
facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
state: Kyiv
city: Lviv
country: Ukraine
facility: Lviv Railway Clinical Hospital
state: Lvivska Oblast
city: Lviv
country: Ukraine
facility: Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
state: Lvivska Oblast
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician
state: Lvivska Oblast
city: Odesa
country: Ukraine
facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
state: Odeska Oblast
city: Poltava
country: Ukraine
facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
state: Poltavska Oblast
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Investigational Center of Medical Center Health Clinic
state: Vinnytska Oblast
city: Vinnytsya
country: Ukraine
facility: City Clinical Hospital #1, Vinnitsya National Medical University
state: Vinnytska Oblast
city: Vinnytsya
country: Ukraine
facility: VNMU
state: Vinnytska Oblast
city: Uzhgorod
country: Ukraine
facility: Transcarpathian Regional Hospital im.Andriya Novak
state: Zakarpatska Oblast
city: Zaporizhia
country: Ukraine
facility: Diaservis - Medical and Diagnostic Center
state: Zaporizka Oblast
city: Zaporizhzhia
country: Ukraine
facility: Diacenter
state: Zaporizka Oblast
city: Kyiv
country: Ukraine
facility: Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
city: Kyiv
country: Ukraine
facility: Medical Center Ok!Clinic+
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
state: Great Britain
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
state: London, City Of
city: Oxford
country: United Kingdom
facility: The John Radcliffe Hospital
state: Oxfordshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: Waltham Forest
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: