Clinical trial NCT05242484: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-02-16
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
* Moderately to severely active UC as assessed by the modified Mayo score
* Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
* If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

* Has severe extensive colitis as defined in the protocol
* Extent of inflammatory disease limited to the rectum
* Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
* Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Primary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants with Endoscopic Improvement at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Symptomatic Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
timeFrame: Week 48
measure: Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Week 48
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 48
measure: Laboratory Parameters Over Time
timeFrame: Up to Week 48
measure: Vital Signs Parameters Over Time
timeFrame: Up to Week 48
measure: Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to Week 48
measure: Serum Concentrations of Guselkumab Over Time
timeFrame: Up to Week 48
measure: Serum Concentrations of Golimumab Over Time
timeFrame: Up to Week 48
measure: Percentage of Participants with Antibodies to Guselkumab
timeFrame: Up to Week 48
measure: Titers of Antibodies to Guselkumab
timeFrame: Up to Week 48
measure: Percentage of Participants with Antibodies to Golimumab
timeFrame: Up to Week 48
measure: Titers of Antibodies to Golimumab
timeFrame: Up to Week 48
measure: Percentage of Participants with Neutralizing Antibodies to Guselkumab
timeFrame: Up to Week 48
measure: Percentage of Participants with Neutralizing Antibodies to Golimumab
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Valley Gastroenterology Medical Group
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Coconut Creek
country: United States
facility: Pioneer Research Solutions Inc.
state: Florida
city: Kissimmee
country: United States
facility: Digestive and Liver Disease Institute
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Hospital
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Center Inc.
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Of Naples
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Saint Petersburg
country: United States
facility: Synergy Clinical Research
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterolgy Associates of Central GA
state: Georgia
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Roswell
country: United States
facility: Gastroenterology Consultants
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Gastroenterology
state: Idaho
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology of Southern Indiana
state: Indiana
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Assoc
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham And Women's Hospital
state: Massachusetts
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates Center for Digestive Care
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Care Access Las Vegas
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock
state: New Hampshire
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Utica
country: United States
facility: Mohawk Valley Endoscopy Center
state: New York
city: Chapel Hill
country: United States
facility: University North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Tryon Medical Group
state: North Carolina
city: Charlotte
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Kinston
country: United States
facility: Care Access Research, Kinston
state: North Carolina
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Uniontown
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rock Hill
country: United States
facility: Digestive Disease Associates
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Johnson City
country: United States
facility: Etsu Quillen College Of Medicine
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: GI Specialists of Houston
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic Of San Antonio P A
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Richmond
country: United States
facility: Medical College Of Virginia Hospital
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology, PLLC
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Digestive Health Specialists
state: Washington
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Cordoba
country: Argentina
facility: Sanatorio Duarte Quiroz
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
city: Concord
country: Australia
facility: Concord Hospital
city: Footscray
country: Australia
facility: Western Health
city: Maroochydore
country: Australia
facility: Coastal Digestive Health
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: North Terrace
country: Australia
facility: Royal Adelaide Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Prahran
country: Australia
facility: The Alfred Hospital
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
city: Salzburg
country: Austria
facility: Universitaetsklinikum Salzburg Landeskrankenhaus
city: Wels
country: Austria
facility: Klinikum Wels Grieskirchen
city: Wien
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
city: Wien
country: Austria
facility: Medizinische Universitaet Wien
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU de Liege
city: Liège
country: Belgium
facility: CHC MontLegia
city: Sint-Niklaas
country: Belgium
facility: Vitaz
city: Botucatu
country: Brazil
facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'
city: Brasilia
country: Brazil
facility: L2IP Instituto de Pesquisas Clinicas
city: Brasilia
country: Brazil
facility: Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
city: Caxias Do Sul
country: Brazil
facility: Fundacao Universidade de Caxias do Sul
city: Curitiba
country: Brazil
facility: Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Hospital De Clinicas De Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Faculdade de Medicina
city: Salvador
country: Brazil
facility: SER - Servicos Especializados em Reumatologia da Bahia
city: Santo Andre
country: Brazil
facility: Pesquisare Saude
city: Santos
country: Brazil
facility: Irmandade da Santa Casa da Misericórdia de Santos
city: Sao Paulo
country: Brazil
facility: Hospital Nove de Julho
city: Sao Paulo
country: Brazil
facility: BR Trials
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
city: São Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Haskovo
country: Bulgaria
facility: Medical Centre Hipocrat
city: Sliven
country: Bulgaria
facility: Diagnostic Consulting Center I Sliven
city: Sofia-Grad
country: Bulgaria
facility: University Hospital Alexandrovska - Clinic of Nephrology
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna'
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center -Medika Plus
city: Vratsa
country: Bulgaria
facility: Multriprofile Hospital for Active Treatment Hristo Botev
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Gastroenterology and Internal Medicine Research Institute (GIRI)
state: Alberta
city: Edmonton
country: Canada
facility: Covenant Health/Grey Nuns hospital
state: Alberta
city: New Westminster
country: Canada
facility: Columbia Gastroenterology
state: British Columbia
city: Vancouver
country: Canada
facility: The Gordon & Leslie Diamond Health Care Center
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI Gastrointestinal Research Institute
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Dartmouth
country: Canada
facility: Viable Clinical Research
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
state: Ontario
city: Toronto
country: Canada
facility: Toronto Immune and Digestive Health Institute Inc
state: Ontario
city: Mont-Royal
country: Canada
facility: CMIIM, Centre médical L'Enjeu
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University - Health Centre - Montreal General Hospital
state: Quebec
city: Saint-Jerome
country: Canada
facility: St. Jerome Medical Research
state: Quebec
city: Bridgewater
country: Canada
facility: Viable Clinical Research
city: Saguenay
country: Canada
facility: Hopital Chicoutimi
city: Concepcion
country: Chile
facility: Hospital Clinico Regional Dr. Guillermo Grant Benavente
city: Santiago
country: Chile
facility: Clinica Dermacross S A
city: Santiago
country: Chile
facility: Complejo Asistencial Hospital Dr. Sótero del Río
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos e Investigación Médica (CeCim)
city: Chaoyang
country: China
facility: China Japan Friendship Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Bjelovar
country: Croatia
facility: Opca bolnica Bjelovar
city: Split
country: Croatia
facility: University Hospital Center Split
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno
city: Praha 9
country: Czechia
facility: ISCARE a.s.
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Og Frederiksberg Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital, University of Copenhagen
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: AMIENS cedex 1
country: France
facility: CHU Amiens - Hopital Sud
city: Colombes Cedex
country: France
facility: Hopital Louis Mourier
city: Créteil
country: France
facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental VENDEE
city: Lille
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Marseille
country: France
facility: Hopital Nord Marseille
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Pare
city: Nice cedex 03
country: France
facility: CHU de Nice Hopital de l Archet
city: Nîmes
country: France
facility: CHU Nimes Hopital Caremeau
city: Pessac
country: France
facility: Hopital Haut-Leveque, CMC Magellan
city: Pierre Bénite
country: France
facility: Hospices Civils de Lyon HCL
city: Saint Etienne
country: France
facility: CHU Saint Etienne
city: Toulouse cedex 09
country: France
facility: Hopital de Rangueil
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy Brabois
city: Berlin-Karlshorst
country: Germany
facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Berlin
country: Germany
facility: Praxis Für Gastroenteroligie
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin (CCM)
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede Mitte
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Frankfurt/Main
country: Germany
facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
city: Frankfurt
country: Germany
facility: JWG-University Hospital
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Fulda
country: Germany
facility: Klinikum Fulda - Tumorklinik - Germany
city: Halle (Saale)
country: Germany
facility: Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
city: Halle
country: Germany
facility: BSF Studiengesellschaft
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow
city: Leipzig
country: Germany
facility: Eugastro GmbH
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Munich
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Munster
country: Germany
facility: Praxis fur Innere Medizin und Gastroenterologie
city: Münster
country: Germany
facility: MVZ Portal 10
city: Nürtingen
country: Germany
facility: Medius Klinik Nürtingen
city: Pforzheim
country: Germany
facility: Siloah St Trudpert Klinikum
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saar MVZ GmbH
city: Tübingen
country: Germany
facility: Universitaetsklinik Tuebingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Wipperfürth
country: Germany
facility: Gemeinschaftspraxis Jakobeit
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Athens
country: Greece
facility: Sotiria General State Hospital of Chest Diseases
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
city: Piraievs
country: Greece
facility: Nikaia General Hospital
city: Thessaloniki
country: Greece
facility: Hippokration Hospital
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospital
city: Bhubaneswar
country: India
facility: Siksha O Anusandhan University - Institute of Medical Scienc
city: Jaipur
country: India
facility: Apex Hospitals Ltd
city: New Delhi
country: India
facility: G.B. Pant Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: New Delhi
country: India
facility: Fortis Hospital
city: Secunderabad
country: India
facility: Yashoda Super Speciality Hospitals
city: Surat
country: India
facility: Surat Institute of Digestive Sciences Hospitals
city: Afula
country: Israel
facility: Haemek Medical Center - Afula
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bari
country: Italy
facility: Università degli Studi di Bari
city: Catania
country: Italy
facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
city: Messina
country: Italy
facility: AOU Policlinico G.Martino
city: Milano
country: Italy
facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
city: Monserrato
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Negrar Di Valpolicella
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Palermo
country: Italy
facility: Ospedale Villa Sofia-Cervello
city: Roma
country: Italy
facility: Università Campus Biomedico di Roma
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Rozzano
country: Italy
facility: IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
city: Bunkyo Ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Fukuoka-ken
country: Japan
facility: Kitakyushu Municipal Medical Center
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki General Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
city: Kamakura
country: Japan
facility: Ofuna Chuo Hospital
city: Kanagawa
country: Japan
facility: Matsushima Clinic
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kofu-Shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Maebashi
country: Japan
facility: Gunma University Hospital
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Oita
country: Japan
facility: Oita Red Cross Hospital
city: Osaka-shi
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Japan Community Health Care Organization Osaka Hospital
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo Chuo-ku
country: Japan
facility: Sapporo IBD Clinic
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 Higashi Tokushukai Hospital
city: Sumida ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: Tokyo Saiseikai Central Hospital
city: Tokyo
country: Japan
facility: National Hospital Organization Tokyo Medical Center
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tomakomai
country: Japan
facility: Oji General Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Toyota
country: Japan
facility: Toyota Kosei Hospital
city: Tsukuba City
country: Japan
facility: University of Tsukuba Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Amman
country: Jordan
facility: Istishari Hospital
city: Amman
country: Jordan
facility: Jordan University Hospital
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: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun university hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung 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: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St.Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit van Amsterdam
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Lower Hutt
country: New Zealand
facility: Hutt Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Alesund
country: Norway
facility: Alesund sjukehus
city: Gjettum
country: Norway
facility: Vestre Viken HF Baerum Sykehus
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet HF Gjøvik
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital HF Ulleval sykehus
city: Tromso
country: Norway
facility: Universitetssykehuset Nord-Norge HF
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki No2
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lodz
country: Poland
facility: AmiCare Centrum Medyczne
city: Lublin
country: Poland
facility: ETG Lublin
city: Lublin
country: Poland
facility: Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
city: Nowy Targ
country: Poland
facility: Allmedica
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Poznan
country: Poland
facility: Synexus Polska Sp z o o
city: Poznan
country: Poland
facility: Twoja Przychodnia
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: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Torun
country: Poland
facility: GASTROMED Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki Dziecka i Mlodziezy
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Mswia
city: Warszawa
country: Poland
facility: Reumatika-Centrum Reumatologii, NZOZ
city: Warszawa
country: Poland
facility: NZOZ Vivamed
city: Warszawa
country: Poland
facility: Bodyclinic Sp. z o.o. sp. k
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Wroclaw
country: Poland
facility: Przychodnia Vistamed
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodnia
city: Zamosc
country: Poland
facility: ETG Zamosc
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte Hospital Santa Maria
city: Loures
country: Portugal
facility: Uls Loures Odivelas - Hosp. Loures
city: Portimao
country: Portugal
facility: Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E
city: Vila Nova de Gaia
country: Portugal
facility: Uls Gaia Espinho
city: Banska Bystrica
country: Slovakia
facility: FNsP F.D.R. Banska Bystrica
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
city: Presov
country: Slovakia
facility: GASTRO I. s.r.o.
city: Vranov nad Toplou
country: Slovakia
facility: Gastroenterology Department ENDOMED, s.r.o.
city: Celje
country: Slovenia
facility: Splosna bolnisnica Celje
city: Ljubljana
country: Slovenia
facility: Univerzitetni klinicni center Ljubljana
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials Lakeview Hospital
city: Cape Town
country: South Africa
facility: Mediclinic Panorama
city: Cape Town
country: South Africa
facility: Groote Schur Hospital
city: Johannesburg
country: South Africa
facility: Practice Dr Naeem Moosa
city: Pretoria
country: South Africa
facility: Emmed Research
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Pamplona
country: Spain
facility: Hosp. de Navarra
city: Pontevedra
country: Spain
facility: Hosp. Montecelo
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Torrejón de Ardoz
country: Spain
facility: Hosp. Univ. de Torrejon
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Stockholm
country: Sweden
facility: Ersta sjukhus
city: Basel
country: Switzerland
facility: Universitatsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Universitatsspital Bern
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger und Seibold
city: St. Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Zuerich
country: Switzerland
facility: UniversitaetsSpital Zuerich
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Division of Infectious Diseases
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, LinKou Branch
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research
city: London
country: United Kingdom
facility: Chelsea And Westminster Hospital
city: London
country: United Kingdom
facility: St George's University Hospital NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: