Clinical trial NCT04033445: A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 1064
Sex: ALL
Minimum age (years): 18
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 guselkumab in participants with moderately to severely active ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of ulcerative colitis (UC)
* Moderately to severely active UC, defined by modified Mayo score
* Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
* Screening laboratory test results within the parameters specified in the protocol

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
* UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
* Presence of a stoma
* Presence or history of a fistula
* Receiving prohibited medications and/or treatment

Primary outcomes:
measure: Induction Study 1: Percentage of Participants With Clinical Response at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12
timeFrame: At Week I-12
measure: Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44
timeFrame: At Week M-44
Secondary outcomes:
measure: Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12
timeFrame: At Week I-12
measure: Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12
timeFrame: At Week I-12
measure: Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12
timeFrame: At Week I-12
measure: Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12
timeFrame: At Week I-12
measure: Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Clinical Response at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4
timeFrame: At Week I-4
measure: Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12
timeFrame: At Week I-12
measure: Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2
timeFrame: At Week I-2
measure: Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12
timeFrame: At Week I-12
measure: Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With Clinical Response at Week M-44
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline
timeFrame: At Week M-44
measure: Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44
timeFrame: At Week M-44
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Hialeah
country: United States
facility: Harmony Medical Research Institute, Inc.
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville Gastroenterology Emerson
state: Florida
city: Kissimmee
country: United States
facility: I.H.S. Health. LLC
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services LLC
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Orlando
country: United States
facility: Care Access Research, Orlando
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research US Inc
state: Florida
city: Tampa
country: United States
facility: Univ. of South Florida Med. Group
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology
state: Georgia
city: Macon
country: United States
facility: Gastroenterolgy Associates of Central GA
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Pratt
country: United States
facility: Health Science Research Center
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Assoc
state: Kentucky
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Clinton Township
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Farmington Hills
country: United States
facility: Revive Research Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Infusion Associates
state: Michigan
city: Kansas City
country: United States
facility: Mid-America Gastro-Intestinal Consultants
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-jewish Hospital
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Raleigh
country: United States
facility: Duke University Hospital Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Springboro
country: United States
facility: Digestive Specialists, Inc
state: Ohio
city: Westlake
country: United States
facility: Gastro Intestinal Research Institute of Northern Ohio LLC
state: Ohio
city: Youngstown
country: United States
facility: Care Access Research, Poland
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc
state: Oklahoma
city: Wyomissing
country: United States
facility: US Digestive Health
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research US Inc
state: South Carolina
city: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg, SC
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Lubbock
country: United States
facility: Caprock Gastro Research
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Ogden
country: United States
facility: Care Access Research, Ogden
state: Utah
city: Salt Lake City
country: United States
facility: Care Access Research- Salt Lake City
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Seattle
country: United States
facility: UW-Harborview Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Medical Group
state: Washington
city: Spokane
country: United States
facility: Velocity Clinical Research Spokane
state: Washington
city: Casper
country: United States
facility: Care Access Research, Casper
state: Wyoming
city: Buenos Aires
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
city: Buenos Aires
country: Argentina
facility: Cer Instituto Medico
city: Buenos Aires
country: Argentina
facility: CINME Centro de Investigaciones Metabolicas
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos José Maria Ramos Mejía
city: Caba
country: Argentina
facility: Centro Médico Dra. De Salvo
city: Ciudad De Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Cordoba
country: Argentina
facility: Sanatorio Duarte Quiroz
city: Florencio Varela
country: Argentina
facility: Hospital de Alta Complejidad en Red 'El Cruce'
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Rosario
country: Argentina
facility: Fundacion de Estudios Clinicos
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Camberwell
country: Australia
facility: Emeritus Research
city: Clayton
country: Australia
facility: Monash Health
city: Footscray
country: Australia
facility: Western Health
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: South Brisbane
country: Australia
facility: Mater Hospital
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Salzburg
country: Austria
facility: Universitaetsklinikum Salzburg Landeskrankenhaus
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Merksem
country: Belgium
facility: Algemeen Ziekenhuis Jan Palfijn Merksem
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Brasilia
country: Brazil
facility: L2IP Instituto de Pesquisas Clinicas
city: Campinas
country: Brazil
facility: Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
city: Curitiba
country: Brazil
facility: CDC - Centro Digestivo de Curitiba
city: Juiz de Fora
country: Brazil
facility: Eurolatino Pesquisas Medicas Ltda
city: Passo Fundo
country: Brazil
facility: Instituto Mederi de Pesquisa e Saude
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Faculdade de Medicina
city: Salvador
country: Brazil
facility: CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
city: Sao Paulo
country: Brazil
facility: BR Trials
city: Sao Paulo
country: Brazil
facility: Onco Star SP Oncologia Ltda
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: Teresina
country: Brazil
facility: Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
city: Uberlandia
country: Brazil
facility: Eurolatino Pesquisas Medicas Ltda
city: Dupnitsa
country: Bulgaria
facility: Medical Centre Asklepii OOD
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: 2-nd MHAT
city: Sofia
country: Bulgaria
facility: 4th MHAT - Sofia
city: Sofia
country: Bulgaria
facility: DCC Convex EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic - Oncology Center
city: Varna
country: Bulgaria
facility: MHAT 'St. Marina' EAD
city: Veliko Tarnovo
country: Bulgaria
facility: MHAT Dr Stefan Cherkezov
city: Vancouver
country: Canada
facility: G I R I GI Research Institute Foundation
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Barrie
country: Canada
facility: Barrie GI Associates
state: Ontario
city: Toronto
country: Canada
facility: Toronto Immune and Digestive Health Institute Inc
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Beijing
country: China
facility: Capital Medical University, Beijing Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central Sourth University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Daping Hospital
city: Dalian
country: China
facility: The Second Hospital To Dalian Medical University
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital Sun Yat sen University
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University College of Medicine
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Kunming City
country: China
facility: First Affiliated Hospital of Kunming Medical Unversity
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Suzhou
country: China
facility: The Second Hospital Affiliated To Suzhou University
city: Suzhou
country: China
facility: The first affiliated hospital of suzhou University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a s
city: Havirov
country: Czechia
facility: Endohope Havirov s.r.o.
city: Hradec Kralova
country: Czechia
facility: Gastroenterologie, s.r.o., Hradec Kralove
city: Olomouc
country: Czechia
facility: MUDr. Gregar s.r.o.
city: Ostrava
country: Czechia
facility: Vitkovicka nemocnice a.s.
city: Ostrava
country: Czechia
facility: Artroscan s r o
city: Prague
country: Czechia
facility: AXON Clinical s.r.o.
city: Praha 2
country: Czechia
facility: Synexus Czech s.r.o.
city: Praha 4
country: Czechia
facility: ResTrial GastroEndo, s.r.o
city: Praha 5
country: Czechia
facility: Nemocnice na Homolce
city: Praha 9
country: Czechia
facility: ISCARE a.s.
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice, a.s.
city: Caen
country: France
facility: CHU caen
city: Clichy
country: France
facility: Hopital Beaujon
city: Lille
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Nice Cedex 3
country: France
facility: CHU de Nice Hopital de l Archet
city: Paris
country: France
facility: Hopital Saint Antoine
city: Pessac
country: France
facility: Hopital Haut-Leveque, CMC Magellan
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Priest en Jarez
country: France
facility: CHU Saint Etienne Hopital Nord
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Toulouse
country: France
facility: CHU Rangueil
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy Brabois
city: Berlin
country: Germany
facility: Universitaetsklinikum Charite, Campus Virchow Klinikum
city: Halle
country: Germany
facility: BSF Studiengesellschaft
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saar MVZ GmbH
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Semmelweis University
city: Debrecen
country: Hungary
facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyongyos
country: Hungary
facility: Gyongyosi Bugat Pal Korhaz
city: Gyula
country: Hungary
facility: Synexus Magyarorszag Kft
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika
city: Dublin 4
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: University Hospital Galway - Ireland
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Lev Talpiot Clinic
city: Naharia
country: Israel
facility: Galilee Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Negrar
country: Italy
facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Ospedale Villa Sofia-Cervello
city: RHO
country: Italy
facility: Azienda Ospedaliera G.Salvini Ospedale di Rho
city: Roma
country: Italy
facility: Università Campus Biomedico di Roma
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli Università Cattolica
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Rozzano, IRCCS
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo Della Sofferenza IRCCS
city: Torino
country: Italy
facility: AO Ordine Mauriziano
city: Bunkyo ku
country: Japan
facility: Institute of Science Tokyo Hospital
city: Chiba
country: Japan
facility: Juntendo University Hospital Urayasu
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Ehime
country: Japan
facility: Ehime Prefectural Central Hospital
city: Fujiidera-shi
country: Japan
facility: Sai Gastroenterology Proctology
city: Fukuoka-ken
country: Japan
facility: Kitakyushu Municipal Medical Center
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hachinohe
country: Japan
facility: Hachinohe City Hospital
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hospital
city: Hashima-gun
country: Japan
facility: Matsunami General Hospital
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki General Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hiroshima
country: Japan
facility: Kure Kyosai Hospital
city: Hokkaido
country: Japan
facility: Asahikawa Medical University Hospital
city: Ibaraki
country: Japan
facility: Mito Saiseikai General Hospital
city: Izumo
country: Japan
facility: Shimane University Hospital
city: Kagoshima City
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Imamura General Hospital
city: Kagoshima
country: Japan
facility: Izuro Imamura Hospital
city: Kagoshima
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
city: Kagoshima
country: Japan
facility: Sameshima Hospital
city: Kanagawa
country: Japan
facility: St Marianna University Hospital
city: Kanagawa
country: Japan
facility: Matsushima Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kashiwa
country: Japan
facility: The Jikei University Kashiwa Hospital
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Kitakyushu
country: Japan
facility: Kyushu Rosai Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kobe
country: Japan
facility: Aoyama Naika Clinic
city: Kochi
country: Japan
facility: National Hospital Organization Kochi National Hospital
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kumagaya-shi
country: Japan
facility: Kumagaya General Hospital
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Meguro ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Miyagi
country: Japan
facility: Takagi Clinic
city: Morioka
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Niigata
country: Japan
facility: Nagaoka Chuo General Hospital
city: Nishinomiya shi
country: Japan
facility: Hyogo Medical University Hospital
city: Oita
country: Japan
facility: Oita Red Cross Hospital
city: Oita
country: Japan
facility: Shinbeppu Hospital
city: Okinawa
country: Japan
facility: Nakagami Hospital
city: Osaka Sayama shi
country: Japan
facility: Kindai University Hospital
city: Osaka
country: Japan
facility: Japanese Red Cross Osaka Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Izumiotsu Municipal Hospital
city: Osaki
country: Japan
facility: Osaki Citizen Hospital
city: Saitama
country: Japan
facility: Japan Community Health Care Organization Saitama Medical Center
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo
country: Japan
facility: Sapporo Tokushukai Hospital
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Sapporo
country: Japan
facility: Sapporo IBD Clinic
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Shinjuku-ku
country: Japan
facility: Tokyo Yamate Medical Center
city: Shizuoka
country: Japan
facility: Matsuda Hospital
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Yokkaichi
country: Japan
facility: Yokkaichi Hazu Medical Center
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital
city: Yoshida
country: Japan
facility: University of Fukui Hospital
city: Amman
country: Jordan
facility: Jordan University Hospital
city: Amman
country: Jordan
facility: Istishari Hospital
city: Amman
country: Jordan
facility: Khalidi Hospital and Medical Center
city: Irbid
country: Jordan
facility: Irbid Specialty Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Health Centre 4 Centre of Diagnostics
city: Riga
country: Latvia
facility: Digestive Diseases Centre GASTRO
city: Kajang
country: Malaysia
facility: Hospital Serdang
city: Kelantan
country: Malaysia
facility: Hospital University Sains Malaysia
city: Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bialystok
country: Poland
facility: Gastromed Kralisz Romatowski Stachurska Sp. j.
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Medis ManerMed Sp Z O O
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lublin
country: Poland
facility: Gastromed ZOZ
city: Oswiecim
country: Poland
facility: Medicome Sp z o.o.
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Sopot
country: Poland
facility: Endoskopia Sp z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Torun
country: Poland
facility: GASTROMED Sp. z o.o.
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: Medical Network WIP Warsaw IBD Point Profesor Kierkus
city: Wroclaw
country: Poland
facility: Wro Medica
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Zamosc
country: Poland
facility: Pro Life Medica Sp z o o ETG Zamosc
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, EPE
city: Porto
country: Portugal
facility: Uls Santo Antonio - Hosp. Santo Antonio
city: Porto
country: Portugal
facility: Uls Sao Joao - Hosp. Sao Joao
city: Santa Maria da Feira
country: Portugal
facility: Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao
city: Viseu
country: Portugal
facility: Centro Hospitalar de Tondela Viseu, EPE
city: Ekaterinburg
country: Russian Federation
facility: Medical Center Meditsinskie Tekhnologii
city: Ekaterinburg
country: Russian Federation
facility: OOO MO New Hospital
city: Kaliningrad
country: Russian Federation
facility: Immanuel Kant Baltic Federal University
city: Nizhniy Novgorod
country: Russian Federation
facility: Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways
city: Novosibirsk
country: Russian Federation
facility: Medical Center SibNovoMed LLC
city: Novosibirsk
country: Russian Federation
facility: LLC 'Novosibirsk Gastrocentr'
city: Perm
country: Russian Federation
facility: City Clinical Hospital #2
city: Rostov-On-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: All-Russian Center of Emergency and Radiation Medicine MCRS
city: Saint-Petersburg
country: Russian Federation
facility: Eco-safety Ltd
city: Samara
country: Russian Federation
facility: Medical University Reaviz
city: Samara
country: Russian Federation
facility: NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
city: Saratov
country: Russian Federation
facility: Saratov Regional Clinical Hospital
city: St-Petersburg
country: Russian Federation
facility: International Medical Centre SOGAZ
city: Ufa
country: Russian Federation
facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
city: Ufa
country: Russian Federation
facility: City Clinical Hospital # 21
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Zvezdara University Medical Center
city: Sombor
country: Serbia
facility: General Hospital 'Dr Radivoj Simonovic'
city: Zrenjanin
country: Serbia
facility: General Hospital 'Djordje Joanovic'
city: Banska Bystrica
country: Slovakia
facility: FNsP F.D.R. Banska Bystrica
city: Bardejov
country: Slovakia
facility: Gastroenterology Department GASTROMART s.r.o.
city: Bratislava
country: Slovakia
facility: Gastroenterology Center ASSIDUO
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
city: Kosice
country: Slovakia
facility: ENDOMED s.r.o
city: Presov
country: Slovakia
facility: GASTRO I. s.r.o.
city: Sahy
country: Slovakia
facility: Accout Center, s.r.o., Gastroenterologická ambulancia
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Girona
country: Spain
facility: Hosp. Univ. Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Sevilla
country: Spain
facility: Hosp. Ntra. Sra. de Valme
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Uppsala University
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, LinKou Branch
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
city: Ankara
country: Turkey
facility: Gazi University Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Medicana International Istanbul
city: Istanbul
country: Turkey
facility: BAU Medical Park Goztepe Hospital
city: Istanbul
country: Turkey
facility: Acibadem Kozyatagi Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
city: Kharkiv
country: Ukraine
facility: SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
city: Kherson
country: Ukraine
facility: Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
city: Kyiv
country: Ukraine
facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
city: Kyiv
country: Ukraine
facility: MC PE Sygma
city: Lviv
country: Ukraine
facility: Limited Liability Company Progastro Clinic
city: Lviv
country: Ukraine
facility: Kalyna Center of Modern Medicine
city: Odesa
country: Ukraine
facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
city: Sumy
country: Ukraine
facility: Sumy State University, Sumy Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
city: Vinnytsya
country: Ukraine
facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy
city: Vinnytsya
country: Ukraine
facility: Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
city: London
country: United Kingdom
facility: St George's Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: