Clinical trial NCT03524092: A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Interleukin-23 (IL-23)
IL-23p19
Inflammatory Bowel Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-05-14
Enrollment: 1177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).


Eligibility criteria: Inclusion Criteria:

* Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
* Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
* If female, must meet the contraception requirements.

Exclusion Criteria:

* Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
* Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
* Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
* Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
* Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
* Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

Primary outcomes:
measure: Percentage of Participants in Clinical Remission at Week 40
timeFrame: Week 40
Secondary outcomes:
measure: Percentage of Participants in Endoscopic Remission at Week 40
timeFrame: Week 40
measure: Percentage of Participants With Histologic Remission at Week 40
timeFrame: Week 40
measure: Percentage of Participants in Symptomatic Remission at Week 40
timeFrame: Week 40
measure: Percentage of Participants in Endoscopic Response at Week 40
timeFrame: Week 40
measure: Percentage of Participants in Clinical Response at Week 40
timeFrame: Week 40
measure: Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
timeFrame: Induction Baseline, Week 40
measure: Change From Baseline to Week 40 in Fecal Calprotectin
timeFrame: Induction Baseline, Week 40
measure: Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
timeFrame: Induction Baseline, Week 40
measure: Percentage of Participants Hospitalized for Ulcerative Colitis (UC)
timeFrame: Week 40
measure: Pharmacokinetics (PK): Clearance of Mirikizumab
timeFrame: Predose: Weeks 0, 4, 12, 24 and 40
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Litchfield Park
country: United States
facility: Dcr-Pi, Pc
state: Arizona
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
city: Tempe
country: United States
facility: Physicians Research Group
state: Arizona
city: Arcadia
country: United States
facility: Valley Gastroenterology
state: California
city: Berkeley
country: United States
facility: Care Access Research
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: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: SIH Research, LLC
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida, LLC
state: Florida
city: Orlando
country: United States
facility: Center for Interventional Endoscopy
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
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners LLC
state: Louisiana
city: New Orleans
country: United States
facility: Nola Research Works, LLC
state: Louisiana
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Plymouth
country: United States
facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
state: Minnesota
city: Jackson
country: United States
facility: Care Access Research LLC
state: Mississippi
city: Tupelo
country: United States
facility: Digestive Health Specialists
state: Mississippi
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Center for Inflammatory Bowel Disease
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases and Endoscopy Center
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Poland
country: United States
facility: Care Access - Youngstown
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
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: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Hixson
country: United States
facility: Galen Medical Group
state: Tennessee
city: Garland
country: United States
facility: Digestive Health Associates of Texas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Ins
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, LLC
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Ogden
country: United States
facility: Care Access Research LLC - Salt Lake City
state: Utah
city: Leesburg
country: United States
facility: Emeritas Research Group
state: Virginia
city: Reston
country: United States
facility: The Gastroenterology Group, P.C.
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Caba
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Ciudad Autonoma De Buenos Air
country: Argentina
facility: Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER Instituto Medico
state: Buenos Aires
city: Rosario
country: Argentina
facility: Fundación de Estudios Clínicos
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: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba SA
city: Harlow
country: Australia
facility: Princess Alexandra Hospital
state: Essex
city: Maroochydore
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: South Brisbane
country: Australia
facility: Mater University Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital Outpatients
state: Victoria
city: Malvern
country: Australia
facility: Melbourne Gastrointestinal Investigation Unit (MGIU)
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Salzburg
country: Austria
facility: Universitätsklinikum Salzburg
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame
state: Wallonne, Région
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Edmonton
country: Canada
facility: West Edmonton Diabetes Center
state: Alberta
city: Vancouver
country: Canada
facility: The Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: GI Research Institute
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 of Western Ontario
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneure-Rosemount
state: Quebec
city: Montreal
country: Canada
facility: Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
state: Quebec
city: Hefei City
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei City
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Kaifu District
country: China
facility: Xiangya Hospital Central South University
state: Changsha City
city: Chongqing
country: China
facility: The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
state: Chongqing
city: Chongqing
country: China
facility: The First Hospital Affiliated to AMU (Southwest Hospital)
state: Chongqing
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Nanjing
country: China
facility: The Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Jiangsu
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Jilin
country: China
facility: Jilin Central General Hospital
state: Jilin
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
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: Shanghai Jiaotong University School of Medicine Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Affliated to Shanghai Jiaotong University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kunming
country: China
facility: Kunming Medical College Affiliated First Hospital
state: Yunnan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Med
state: Zhejiang
city: Hangzhou
country: China
facility: First Affiliated Hosp of College of Med, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
state: Zhejiang
city: Wuhan
country: China
facility: Tongji Hospital of Tongji University
city: Brno
country: Czechia
facility: Vojenská Nemocnice Brno
state: Brno-město
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Hl. M. Praha
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: Prague
country: Czechia
facility: MEDIENDO
state: Praha 8
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Praha 9
country: Czechia
facility: ISCARE Clinical Centre
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital Køge
city: Strasbourg Cedex
country: France
facility: Hopital de Hautepierre - Service d'Hépatogastroentérolgie
state: Bas Rhin
city: Paris
country: France
facility: Hopital Saint-Louis
state: Cedex 10
city: Lille cedex
country: France
facility: CHU Lille - Hôpital Claude Huriez
state: Nord
city: Clichy
country: France
facility: Hôpital Beaujon
state: Paris
city: Pau
country: France
facility: Centre Hospitalier de Pau
state: Pyrénées-Atlantiques
city: Pierre Benite cedex
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
state: Rhone
city: Amiens Cedex
country: France
facility: CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
state: Somme
city: Chambray les Tours
country: France
facility: CHU Tours - Hôpital Trousseau
city: Marseille Cedex 20
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord
city: Montpellier Cedex 5
country: France
facility: CHRU de Montpellier-Hopital St Eloi
city: Nice Cedex
country: France
facility: Hopital L'Archet 2
city: Pessac Cedex
country: France
facility: CHU Bordeaux - Hôpital Haut-Lévêque
city: Reims
country: France
facility: Robert Debre Hospital
city: Saint Priest en Jarez
country: France
facility: CHU de Saint Etienne Hopital Nord
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy Brabois - Hôpital d'Enfants
city: Hannover
country: Germany
facility: Medizinische Hochschule Hanover
state: Niedersachsen
city: Ludwigshafen am Rhein
country: Germany
facility: Gemeinschaftspraxis Dr. Peter Uebel
state: Rheinland-Pfalz
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
state: Sachsen-Anhalt
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede
city: Brandenburg
country: Germany
facility: Städtisches Klinikum Brandenburg
city: Hamburg
country: Germany
facility: HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
city: Weyhe
country: Germany
facility: Internistische Praxisgemeinschaft
city: Balatonfüred
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft.
state: EU
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház
state: Pest
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Miskolc
country: Hungary
facility: Endomedix Diagnosztikai Központ - Miskolc
city: Mosonmagyarovar
country: Hungary
facility: Karolina Korhaz-Rendelointezet
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
city: Szekszard
country: Hungary
facility: CLINFAN Szolgáltató Kft
city: Hyderabad
country: India
facility: Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
state: Andhra Pradesh
city: New Delhi
country: India
facility: Escorts Heart Institute and Research Centre Ltd
state: Delhi
city: Gandhinagar
country: India
facility: Apollo Research and Innovations, Apollo Hospitals International Ltd
state: Gujarat
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
state: Gujarat
city: Surat
country: India
facility: Nirmal Hospital Pvt Ltd.
state: Gujarat
city: Bangalore
country: India
facility: Bangalore Medical College and Research Institute
state: Karnataka
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: Poona Medical Foundation. Ruby Hall Clinic
state: Maharashtra
city: Wardha
country: India
facility: Datta Meghe Institute of Medical Sciences (DU), 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: Gandhi Hospital
state: Telangana
city: Lucknow
country: India
facility: King George Medical University
state: Uttar Pradesh
city: Dublin
country: Ireland
facility: Beaumont Hospital, Dublin
city: Bait Vagan
country: Israel
facility: Shaare Zedek Medical Center
state: Jerusalem
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center - Pediatric Outpatient Clinic
city: Nahariya
country: Israel
facility: Galilee Medical Center Department of Internal Medicine A
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Zerifin
country: Israel
facility: King Fahad Medical City
city: Rho
country: Italy
facility: Presidio di Rho
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: San Donato Milanese
country: Italy
facility: Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
state: Milano
city: Rome
country: Italy
facility: Ospedale Sandro Pertini
state: Roma
city: Torre
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: Roma
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Catanzaro
country: Italy
facility: Azienda ospedaliero-universitaria Mater Domini
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Milano
country: Italy
facility: Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico de Modena
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital
state: Aichi-ken
city: Toyoake
country: Japan
facility: Fujita Health University
state: Aichi
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: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
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: Ibaraki-machi
country: Japan
facility: NHO Mito Medical Center
state: HigaShiibaraki-Gun
city: Asahikawa
country: Japan
facility: Asahikawa City Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tokushukai Sapporo Tokushukai Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General 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: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Yokohama-shi
country: Japan
facility: Sankikai Yokohama Shin midori General Hospital
state: Kanagawa-Ken
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: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Sendai-shi
country: Japan
facility: Takagi Clinic - Sendai
state: Miyagi-Ken
city: Nagaoka-shi
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: Osaka-shi
country: Japan
facility: Infusion Clinic
state: Osaka
city: Osaka-shi
country: Japan
facility: NHO Osaka National Hospital
state: Osaka
city: Saga-Shi
country: Japan
facility: Saga-Ken Medical Center Koseikan
state: Saga-Ken
city: Kumagaya-shi
country: Japan
facility: Kumagaya General Hospital
state: Saitama-Ken
city: Hamamatsu-shi
country: Japan
facility: Matsuda Hospital
state: Shizuoka-Ken
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi-Ken
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo-To
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: 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: Shinjuku-ku
country: Japan
facility: JHCO Tokyo Yamate Medical Center
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima 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: Saitama
country: Japan
facility: Tokitokai Tokito Clinic
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Wonju-si
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Gangwon-do
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Korea
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung 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: 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: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univeristy Medical Center
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
state: Rīga
city: Riga
country: Latvia
facility: Digestive Diseases Center "Gastro"
city: Riga
country: Latvia
facility: Riga Eastern Clinical University Hospital
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: Klaipeda
country: Lithuania
facility: Klaipeda Seamen's Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre
state: Kuala Lumpur
city: Ampang
country: Malaysia
facility: Hospital Ampang
state: Selangor
city: Mexico City
country: Mexico
facility: Centro de Investigación Clínica Acelerada
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
state: Jalisco
city: Culiacan
country: Mexico
facility: Centro Para el Desarrollo de la Medicina y de Asistencia Medica 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: Tilburg
country: Netherlands
facility: St Elisabeth Ziekenhuis
state: Noord Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
city: Uden
country: Netherlands
facility: Bernhoven Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht, Dept. of Internal Medicine, MDL
city: Wroclaw
country: Poland
facility: LexMedica
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: ZOZ Gastromed
state: Lubelskie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
state: Lubelskie
city: Warsaw
country: Poland
facility: NZOZ Vivamed
state: Mazowieckie
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: Szczecin
country: Poland
facility: SONOMED Centrum Medyczne
state: Zachodniopomorskie
city: Katowice
country: Poland
facility: All-Medicus
city: Olsztyn
country: Poland
facility: Wojewodzki Specjalistyczny Szpital w Olsztynie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Torun
country: Poland
facility: Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
city: Warszawa
country: Poland
facility: Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Wroclaw
country: Poland
facility: PlanetMed Sp.z o.o.
city: Zamosc
country: Poland
facility: ETG Zamość
city: Bedzin
country: Poland
facility: Promedica Dental Clinic
state: Śląskie
city: Straszów
country: Poland
facility: KO-Med Centrum Medyczne
state: Świętokrzyskie
city: Bucharest
country: Romania
facility: CCBR Clinical Research
state: București
city: Bucuresti
country: Romania
facility: MedLife Grivita
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Hifu Terramed Conformal SRL
city: Oradea
country: Romania
facility: Spital Pelican Oradea
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: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Hospital N.A. Semashko
state: Nizhegorodskaya Oblast'
city: Nizhny Novgorod
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
state: Nizhegorodskaya Oblast'
city: Novosibirsk
country: Russian Federation
facility: Novosibirski Gastrocenter
state: Novosibirskaya Oblast'
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
state: Rostovskaya Oblast'
city: Saint Petersburg
country: Russian Federation
facility: Scientific research center ECO-security
state: Sankt-Peterburg
city: Barnaul
country: Russian Federation
facility: Multidisciplinary Medical Clinic "Anthurium"
city: Cherepovets
country: Russian Federation
facility: Medical and Sanitary Division of Severstal
city: Ekaterinburg
country: Russian Federation
facility: LLC MA New Hospital
city: Izhevsk
country: Russian Federation
facility: Alliance Biomedical URAL Group
city: Kaliningrad
country: Russian Federation
facility: Clinical Trials Center of Medical Institute
city: Kazan
country: Russian Federation
facility: State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
city: Kemerovo
country: Russian Federation
facility: SIH Kemerovo Regional Clinical Hosptial
city: Moscow
country: Russian Federation
facility: Medical rehabilitation center
city: Novosibirsk
country: Russian Federation
facility: LLC "Medicine Center SibNovoMed"
city: Omsk
country: Russian Federation
facility: Clinical Diagnostic Center Ultramed
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Medical University n.a. Pavlov I.P.
city: Saint-Petersburg
country: Russian Federation
facility: Pokrovskaya Municipal Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
city: Saint-Petersburg
country: Russian Federation
facility: SBIH City Clinical Hospital #31
city: Samara
country: Russian Federation
facility: Medical Institute REAVIZ
city: St. Petersburg
country: Russian Federation
facility: City Mariinskaya Hospital
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Municipal HI Clinical Hospital #8
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
state: Beograd
city: Belgrade
country: Serbia
facility: University Medical Center "Bezanijska kosa"
state: NAP
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 Gastroenterohepatology Clinic
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: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
state: Andalucía
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Baleares Islands
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Fuenlabrada
country: Spain
facility: Hospital De Fuenlabrada
state: Madrid
city: Sagunto
country: Spain
facility: Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
state: Valencia
city: Alicante
country: Spain
facility: Instituto de Ciencias Médicas
city: Girona
country: Spain
facility: Hospital Universitari de Girona
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña, CHUAC
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital De Gran Canaria Dr. Negrin
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger, Seibold & Partner
state: Berne
city: Berne
country: Switzerland
facility: Inselspital Bern
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Health management center
city: Kocaeli
country: Turkey
facility: Antalya Egitim ve Arastırma Hastanesi
state: Antalya
city: Kadıkoy
country: Turkey
facility: Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
state: Istanbul
city: Izmit
country: Turkey
facility: Kocaeli University Medical Faculty Hospital
state: Kocaeli
city: Yenişehir
country: Turkey
facility: Mersin University Medical Faculty
state: Mersin
city: Izmir
country: Turkey
facility: Ege Universitesi Hastanesi
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
state: Ivano-Frankivsk Region
city: Kharkiv
country: Ukraine
facility: City Clinical Hospital No. 2
state: Kharkivska Oblast
city: Kherson
country: Ukraine
facility: Kherson City Clinical Hospital
state: Khersonska 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: Lviv Regional Endocrinology Dispensary
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: Poltava
country: Ukraine
facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
state: Poltavska Oblast
city: Zaporizhia
country: Ukraine
facility: Diaservis - Medical and Diagnostic Center
state: Zaporizka Oblast
city: Kharkiv
country: Ukraine
facility: Kharkiv City Student Hospital
city: Kharkiv
country: Ukraine
facility: GI L.T. Malaya TI Namsu
city: Kropyvnytskyi
country: Ukraine
facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #1
city: Kyiv
country: Ukraine
facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
city: Kyiv
country: Ukraine
facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
city: Odesa
country: Ukraine
facility: Communal Enterprise "Odesa Regional Clinical Hospital"
city: Uzhgorod
country: Ukraine
facility: A. Novak Transcarpathian Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
city: Vinnytsia
country: Ukraine
facility: MCIC MC LLC Health Clinic
city: Vinnytsia
country: Ukraine
facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
city: Vinnytsya
country: Ukraine
facility: M.I. Pyrogov Regional Clinical Hospital
city: Zaporizhzhia
country: Ukraine
facility: Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
city: Romford
country: United Kingdom
facility: Queens Hospital
state: Essex
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
state: Great Britain
city: Great Maze Pond
country: United Kingdom
facility: St Thomas' Hospital
state: London
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Surrey
city: Swansea
country: United Kingdom
facility: Morriston Hospital
state: Swansea [Abertawe Gb-ata]
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: Vinnytsia
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: