Clinical trial NCT05197049: A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Crohn Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 350
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 Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Crohn's disease (CD) of at least 3 months in duration
* Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

* Current diagnosis of ulcerative colitis or indeterminate colitis
* Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
* Unstable doses of concomitant Crohn's disease therapy

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Who Achieved Endoscopic Response at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission at Week 24
timeFrame: At Week 24
measure: Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Who Achieved Clinical Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48
timeFrame: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
measure: Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48
timeFrame: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48
timeFrame: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Chandler
country: United States
facility: Advanced Gastro P.C
state: Arizona
city: Scottsdale
country: United States
facility: Reliance Research
state: Arizona
city: Little Rock
country: United States
facility: Moore Clinical Trials, LLC
state: Arkansas
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Alamitos
country: United States
facility: United Gastroenterologists
state: California
city: Los Angeles
country: United States
facility: Paul Wallace MD
state: California
city: Orange
country: United States
facility: Clinnova Research
state: California
city: Pasadena
country: United States
facility: Digestive System Healthcare
state: California
city: San Diego
country: United States
facility: Northshore Gastroenterology Research, LLC
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc
state: California
city: Santa Maria
country: United States
facility: Santa Maria Gastroenterology
state: California
city: Walnut Creek
country: United States
facility: Clinical Research of California
state: California
city: Grand Junction
country: United States
facility: Amel Med LLC Research
state: Colorado
city: Danbury
country: United States
facility: Western Connecticut Health Network/Danbury Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Gastroenterology Associates of SW Florida
state: Florida
city: Coconut Creek
country: United States
facility: Pioneer Research Solutions Inc.
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Hialeah
country: United States
facility: Harmony Medical Research Institute, Inc.
state: Florida
city: Kissimmee
country: United States
facility: Central Florida Gastro Research
state: Florida
city: Miami
country: United States
facility: Community Research Foundation, Inc.
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Of Naples
state: Florida
city: Orlando
country: United States
facility: Center for Digestive Health
state: Florida
city: Orlando
country: United States
facility: Central Florida Internists
state: Florida
city: Saint Petersburg
country: United States
facility: Synergy Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
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: Roswell
country: United States
facility: Gastroenterology Consultants
state: Georgia
city: Boise
country: United States
facility: USF Asthma, Allergy, Immunology Clinical Research Unit
state: Idaho
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLLC
state: Idaho
city: Oakbrook Terrace
country: United States
facility: Lemah Creek Clinical Research
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Leawood
country: United States
facility: BVL Clinical Research
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Health Center
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Assoc
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: Institute for Digestive Health and Liver Disease
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Chelmsford
country: United States
facility: Digestive Health Specialists PC
state: Massachusetts
city: South Dartmouth
country: United States
facility: FC Research, LLC
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Livonia
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Jackson Heights
country: United States
facility: Smart Medical Research
state: New York
city: Middletown
country: United States
facility: Crystal Run Healthcare LLP
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education & Research
state: New York
city: Queens
country: United States
facility: A1 Clinical Network
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Gastroenterology Associates of the Piedmont, P.A.
state: North Carolina
city: Columbus
country: United States
facility: Central Ohio Endoscopy Center LLC
state: Ohio
city: Dayton
country: United States
facility: Dayton Gastroenterology, Inc
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Integris Baptist Office
state: Oklahoma
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Smithfield
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Greenville
country: United States
facility: Gastroenterology Associates P.A.
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Health Specialists
state: South Carolina
city: Lubbock
country: United States
facility: West Texas Clinical Research
state: Texas
city: Richmond
country: United States
facility: Victoria Gastroenterology
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic Of San Antonio P A
state: Texas
city: San Antonio
country: United States
facility: Wellness Clinical Research
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Salt Lake City
country: United States
facility: Care Access Research- Salt Lake City
state: Utah
city: Burke
country: United States
facility: Burke Internal Medicine and Research
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: Hopital Erasme
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Banja Luka
country: Bosnia and Herzegovina
facility: University hospital Clinical centre Banja Luka
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Sarajevo
country: Bosnia and Herzegovina
facility: Polyclinic Dr. Al-Tawil
city: Tesanj
country: Bosnia and Herzegovina
facility: General Hospital Tesanj
city: Tuzla
country: Bosnia and Herzegovina
facility: Plava poliklinika Tuzla
city: Zenica
country: Bosnia and Herzegovina
facility: Cantonal Hospital Zenica
city: Botucatu
country: Brazil
facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'
city: Brasilia
country: Brazil
facility: CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
city: Brasilia
country: Brazil
facility: Chronos Clinica Medica Ltda
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: Fortaleza
country: Brazil
facility: Universidade Federal Do Ceara
city: Jau
country: Brazil
facility: Centro de Estudos Clínicos do Interior Paulista - CECIP
city: Macae
country: Brazil
facility: Cliged
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Passo Fundo
country: Brazil
facility: Instituto Mederi de Pesquisa e Saude
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
city: Porto Alegre
country: Brazil
facility: NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
city: Recife
country: Brazil
facility: Hospital das Clinicas - Universidade Federal de Pernambuco
city: Salvador
country: Brazil
facility: Universidade Federal da Bahia - Hospital Professor Edgard Santos
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 Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: BR TRIALS Ensaios Clinicos e Consultoria Ltda
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
city: Sao Paulo
country: Brazil
facility: Hepatogastro
city: São Bernardo do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
city: São José Do Rio Preto
country: Brazil
facility: Kaiser Hospta
city: São Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Teresina
country: Brazil
facility: Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
city: Votuporanga
country: Brazil
facility: Integral Centro de Pesquisas Clinicas
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Bengbu
country: China
facility: The Affiliated Hospital of Bengbu Medical College
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
city: Changzhou City
country: China
facility: Changzhou No 2 Peoples Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: China
country: China
facility: The First People's Hospital of Foshan
city: Chongqing
country: China
facility: Chongqing Medical University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: GuangZhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: Guangzhou Medical University
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
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: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Nanjing
country: China
facility: Nanjing 1st Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Quanzhou
country: China
facility: The First Hospital of Quanzhou
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Suzhou
country: China
facility: The first affiliated hospital of suzhou University
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Yangzhou
country: China
facility: Yangzhou First People's Hospital
city: ZhuZhou
country: China
facility: ZhuZhou Central Hospital
city: Bjelovar
country: Croatia
facility: Opca bolnica Bjelovar
city: Split
country: Croatia
facility: University Hospital Center Split
city: Zadar
country: Croatia
facility: Opca bolnica Zadar
city: Zagreb
country: Croatia
facility: Poliklinika Solmed
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Kladno
country: Czechia
facility: Oblastni nemocnice Kladno a.s.
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Hilleroed
country: Denmark
facility: Nordsjaellands Hospital - Hillerod
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Besancon Cedex
country: France
facility: CHRU Besancon Hopital Jean Minjoz
city: Colombes Cedex
country: France
facility: Hopital Louis Mourier
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Paris
country: France
facility: Hôpital Bichat
city: Pierre Bénite
country: France
facility: Hospices Civils de Lyon HCL
city: Reims
country: France
facility: Hôpital Robert Debré
city: Saint-Priest en Jarez
country: France
facility: CHU Saint Etienne Hopital Nord
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toulouse
country: France
facility: CHU Rangueil
city: Berlin-Karlshorst
country: Germany
facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
city: Berlin
country: Germany
facility: DRK Kliniken Westend
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede Mitte
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig
city: Dachau
country: Germany
facility: Medizinisches Versorgungszentrum (MVZ) Dachau
city: Duisburg
country: Germany
facility: MVZ Sanaklinikum Duisburg
city: Halle
country: Germany
facility: BSF Studiengesellschaft
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Nordhausen
country: Germany
facility: Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Egyesített Szent István és Szent László Kórház
city: Budapest
country: Hungary
facility: Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
city: Budapest
country: Hungary
facility: Mh Egészségügyi Központ
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Afula
country: Israel
facility: Haemek Medical Center
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Milano
country: Italy
facility: Istituto Clinico Humanitas Rozzano, IRCCS
city: Roma
country: Italy
facility: Università Campus Biomedico di Roma
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Chuo-ku
country: Japan
facility: Ginza central clinic
city: Fukui-ken
country: Japan
facility: Fukui Prefectural Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka
country: Japan
facility: Japanese Red Cross Fukuoka Hospital
city: Fukuyama
country: Japan
facility: National Hospital Organization Fukuyama Medical Center
city: Gamagori
country: Japan
facility: Gamagori City Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Hachinohe
country: Japan
facility: Hachinohe City Hospital
city: Hamamatsu-shi
country: Japan
facility: Matsuda Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Higashi-Ibaraki
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Hiroshima
country: Japan
facility: Kure Kyosai Hospital
city: Iizuka-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Kita-kyushu
country: Japan
facility: Kyushu Rosai Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Kurume
country: Japan
facility: Hidaka Coloproctologic Clinic
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Yokoyama IBD Clinic
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital
city: Niigata
country: Japan
facility: Niigata University Medical And Dental Hospital
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central 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: Japanese Red Cross Osaka Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Sendai
country: Japan
facility: Takagi Clinic
city: Sunto-gun
country: Japan
facility: National Hospital Organization Shizuoka Medical Center
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Toyota
country: Japan
facility: Toyota Kosei Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Amman
country: Jordan
facility: Khalidi Hospital and Medical Center
city: Amman
country: Jordan
facility: The Speciality Hospital (TSH) / Advanced Clinical Center
city: Amman
country: Jordan
facility: Istiklal Hospital
city: Amman
country: Jordan
facility: Abdali 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: Kyungpook National University Chilgok 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: Busan
country: Korea, Republic of
facility: DongA Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St.Mary's Hospital
city: Dongdaemun-gu
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Gyeonggi
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
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: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: YangCheon-Gu
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Kaunas
country: Lithuania
facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos, Public Institution
city: Johor Bharu
country: Malaysia
facility: Hospital Sultanah Aminah
city: Kota Bharu
country: Malaysia
facility: Hospital University Sains Malaysia
city: Kota Kinabalu
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Bialystok
country: Poland
facility: Gastromed Kralisz Romatowski Stachurska Sp. j.
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed
city: Chrzanow
country: Poland
facility: Sahlgrenska University Hospital
city: Gdynia
country: Poland
facility: Private Practice - Dr. Krzysztof Cymerman
city: Grudziadz
country: Poland
facility: Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Centrum Medyczne ProMiMed
city: Lodz
country: Poland
facility: AmiCare Centrum Medyczne
city: Lodz
country: Poland
facility: IP Clinic Sp. z o.o.
city: Lodz
country: Poland
facility: Centrum Medyczne Med Gastr
city: Lublin
country: Poland
facility: ETG Lublin
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Nowy Targ
country: Poland
facility: Allmedica
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Opole
country: Poland
facility: Twoja Przychodnia
city: Piotrkow Trybunalski
country: Poland
facility: Centrum Medyczne
city: Poznan
country: Poland
facility: EMC Instytut Medyczny SA PL CERTUS
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: Skorzewo
country: Poland
facility: Centrum Medyczne Promed
city: Sopot
country: Poland
facility: Endoskopia Sp z o.o.
city: Sosnowiec
country: Poland
facility: Kiepury Clinic
city: Straszow
country: Poland
facility: KO Med Centrum Medyczne
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 Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
city: Tychy
country: Poland
facility: H-T Centrum Medyczne Endoterapia
city: Warsaw
country: Poland
facility: Endoterapia
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki Dziecka i Mlodziezy
city: Warszawa
country: Poland
facility: Medical Concierge Centrum Medyczne
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Warszawa
country: Poland
facility: NZOZ Vivamed
city: Warszawa
country: Poland
facility: Gabinety Lekarskie Bodyclinic
city: Warszawa
country: Poland
facility: IBD Point Profesor Kierkus
city: Wierzchoslawice
country: Poland
facility: Centrum Zdrowia Tuchow
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 Melita Medical
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
city: Wroclaw
country: Poland
facility: Przychodnia Vistamed
city: Zamosc
country: Poland
facility: ETG Zamosc
city: Banska Bystrica
country: Slovakia
facility: FNsP F.D.R. Banska Bystrica
city: Kosice
country: Slovakia
facility: ENDOMED s.r.o
city: Presov
country: Slovakia
facility: GASTRO I. s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Vseobecna nemocnica Rimavska Sobota
city: Gijón
country: Spain
facility: Hosp. de Cabuenes
city: Huelva
country: Spain
facility: Hosp. Gral. Juan Ramon Jimenez
city: Huelva
country: Spain
facility: Hosp. Gral. Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Villajoyosa
country: Spain
facility: Hosp. de La Marina Baixa
city: Kaoshiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Division of Infectious Diseases
city: Taipei
country: Taiwan
facility: Taipei Medical University
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Ankara Numune Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
city: Zonguldak
country: Turkey
facility: Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: