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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03466411
Other study ID # CR108387
Secondary ID 2017-002195-13CN
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 13, 2018
Est. completion date June 30, 2030

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.


Description:

This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1409
Est. completion date June 30, 2030
Est. primary completion date October 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy - Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD) - Have screening laboratory test results within the protocol specified parameters - A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation - Unstable doses of concomitant Crohn's disease therapy - Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol - Any medical contraindications preventing study participation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Guselkumab Dose 1
Guselkumab will be administered by IV infusion.
Guselkumab Dose 2
Guselkumab will be administered by SC injection.
Guselkumab Dose 3
Guselkumab will be administered by IV infusion.
Guselkumab Dose 4
Guselkumab will be administered by IV infusion.
Guselkumab Dose 5
Guselkumab will be by SC injection.
Guselkumab
Guselkumab will be administered by IV infusion and SC injection.
Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.
Placebo
Placebo will be administered as IV infusion.

Locations

Country Name City State
Australia The Queen Elizabeth Hospital Adelaide
Australia Monash Health, Monash Medical Centre Clayton
Australia Concord Hospital Concord
Australia Austin Hospital Heidelberg
Australia Sir Charles Gairdner Hospital Nedlands
Australia Royal Adelaide Hospital North Terrace
Australia Royal Melbourne Hospital Parkville
Australia Nepean Hospital Penrith
Australia The Alfred Hospital Prahran
Australia Mater Hospital Brisbane South Brisbane
Australia Princess Alexandra Hospital Woolloongabba
Austria Universitaetsklinikum Salzburg Landeskrankenhaus Salzburg
Austria Akh Wien Wien
Belarus Gomel Regional Clinical Hospital Gomel
Belarus Republican Research Centre of Radiation Medicine and Human E Gomel
Belarus Grodno University Hospital Grodno
Belarus Healthcare Institution,Minsk Scientific center for surgery, Minsk
Belarus Vitebsk Regional Clinical Hospital Vitebsk
Belgium AZ Klina Brasschaat
Belgium CHU Saint-Pierre Bruxelles
Belgium Hopital Erasme Bruxelles
Belgium UZ Gent Gent
Belgium Az Groeninge Kortrijk
Belgium Algemeen Ziekenhuis Delta Roeselare
Belgium CHwapi Tournai
Bosnia and Herzegovina University Clinical Centre of the Republic of Srpska Banja Luka
Bosnia and Herzegovina Clinical hospital Mostar Mostar
Bosnia and Herzegovina Clinical Center University of Sarajevo Sarajevo
Bosnia and Herzegovina Polyclinic Dr. Al-Tawil Sarajevo
Bosnia and Herzegovina Cantonal Hospital Zenica Zenica
Brazil MK Blumenau Pesquisa Clínica Blumenau
Brazil Universidade Estadual Paulista 'Julio De Mesquita Filho' Botucatu
Brazil L2IP Instituto de Pesquisas Clinicas Brasilia
Brazil Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro Campinas
Brazil Hospital Nossa Senhora Das Gracas Curitiba
Brazil Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro Goiania
Brazil Centro de Estudos Clínicos do Interior Paulista - CECIP Jau
Brazil CMIP - Centro Mineiro de Pesquisa Ltda Juiz de Fora
Brazil Complexo Hospitalar de Niteroi Niterói
Brazil Instituto Mederi de Pesquisa e Saude Passo Fundo
Brazil Hospital das Clinicas de Porto Alegre Porto Alegre
Brazil Instituto do Aparelho Digestivo Porto Alegre
Brazil Universidade Federal do Rio de Janeiro - Faculdade de Medicina Rio de Janeiro
Brazil Hospital Santa Izabel Salvador
Brazil Pesquisare Saude Santo Andre
Brazil Praxis pesquisa médica Santo Andre
Brazil CEMEC - Centro Multidisciplinar de Estudos Clínicos Santo André
Brazil Irmandade da Santa Casa da Misericórdia de Santos Santos São Paulo
Brazil Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base Sao Jose do Rio Preto
Brazil Kaiser Hospta São José Do Rio Preto
Brazil BR Trials Sao Paulo
Brazil Hemomed Sao Paulo
Brazil CPCLIN - Centro de Pesquisas Clínicas São Paulo
Brazil Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui Teresina
Canada Barrie GI Associates Barrie Ontario
Canada University of Calgary Calgary Alberta
Canada Gastroenterology and Internal Medicine Research Institute (GIRI) Edmonton Alberta
Canada University of Alberta- Ziedler Ledcor Centre Edmonton Alberta
Canada London Health Sciences Centre London Ontario
Canada MUHC Montreal General Hospital Montreal Quebec
Canada Columbia Gastroenterology New Westminster British Columbia
Canada Royal University Hospital Saskatoon Saskatchewan
Canada Mount Sinai Hospital-Toronto Toronto Ontario
Canada Pharmaceutical Integrated Research Company Waterloo Ontario
Canada Health Sciences Centre Winnipeg Manitoba
China Beijing Friendship Hospital Beijing
China Peking University First Hospital Beijing
China Peking University Third Hospital Beijing
China The Military General Hospital of Beijing PLA Beijing
China The second Xiangya Hospital of Central South University Changsha
China Changzhou No 2 Peoples Hospital Changzhou City
China West China Hospital Sichuan University Chengdu
China The Second Affiliated Hospital of Chongqing Medical University Chongqing
China First Affiliated Hospital of Gannan Medical University Ganzhou
China Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou
China Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital Guangzhou
China The First Affiliated Hospital Sun Yat-Sen University Guangzhou
China ZhuJiang Hospital of Southern Medical University Guangzhou
China Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou
China The Second Affiliated Hospital of Zhejiang University Hangzhou
China The 1st affiliated hospital of Anhui Medical University Hefei
China Huai'an 1st Hospital Huai'an
China The First Affiliated Hospital of NanChang University Nanchang
China Nanjing Drum Tower Hospital Nanjing
China Zhongda Hospital Southeast University Nanjing
China Huashan Hospital Fudan University Shanghai
China Ruijin Hospital Shanghai Jiao Tong University Shanghai
China Second Military Medical University (SMMU) Shanghai
China Shanghai Ninth Peoples Hospital Shanghai
China Tongji Hospital of Tongji University Shanghai
China Shengjing Hospital Of China Medical University Shenyang
China Peking University Shenzhen Hospital Shenzhen
China The first affiliated hospital of suzhou University Suzhou
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou
China Renmin Hospital of Wuhan University Wuhan
China Wuhan Union Hospital Wuhan
China Wuxi People s Hospital Wuxi
China Zhongshan Hospital, Xiamen University Xiamen
China Yangzhou First People's Hospital Yangzhou
China Zhangzhou Municipal Hospital of Fujian Province Zhangzhou
Colombia Clinica de la Mujer Bogota
Colombia Endocare Ltda. Bogota
Colombia Medplus Medicina Prepagada S.A. Bogota
Colombia Centro Médico Imbanaco Cali
Colombia Corporacion para Estudios en Salud Clinica CES - Gastroenterology Medellin
Croatia Opca bolnica Bjelovar Bjelovar
Croatia Opca bolnica Zadar Zadar
Croatia CH Sestre Milosrdnice Zagreb
Croatia Poliklinika Solmed Zagreb
Croatia University Hospital Center Zagreb Zagreb
Croatia University Hospital Dubrava Zagreb
Czechia Nemocnice Ceske Budejovice Ceske Budejovice
Czechia NH Hospital, a.s. Horovice
Czechia Hepato-gastroenterologie HK, s.r.o. Hradec Kralove
Czechia Synexus Czech s.r.o. Prague 2
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia ISCARE a.s. Praha 9
France CHU Amiens Amiens
France Centre Hospitalier de la Cote Basque Bayonne
France CHRU Besancon Hopital Jean Minjoz Besançon
France Centre Hospitalier Universitaire (CHU) de Caen Caen
France CHRU de Tours - Hopital Trousseau Chambray Les Tours Centre
France Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor Créteil
France CHU Grenoble Grenoble
France CHRU de Lille Hopital Claude Huriez Lille
France Hopital Nord Marseille Marseille
France CHRU Montpellier - Hopital Saint-Eloi Montpellier Cedex 5
France CHU de Nantes hotel Dieu Nantes
France CHU de Nice Hopital de l Archet Nice cedex 03
France CHU Nimes Hopital Caremeau Nimes
France Groupement Hospitalier Universitaire Ouest Paris
France Hôpital Bichat Paris
France Centre Hospitalier Lyon Sud Pierre-Bénite
France Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré Reims, Cedex
France CHU Saint-etienne Saint Etienne
France Hopital D'Instruction Des Armees Saint Mandé
France CHRU de Strasbourg - Hopital de Hautepierre Strasbourg Cedex
France CHU Toulouse - Hopital de Rangueil Toulouse
France Hopital Rangueil Toulouse
France CHU de Nancy_ Hopital Brabois Vandoeuvre-les-Nancy
Georgia LTD 'Aversi Clinic' T'bilisi
Georgia Institute of Clinical Cardiology, Ltd. Tbilisi
Georgia LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital' Tbilisi
Georgia LTD Helsicore Tbilisi
Georgia TSMU The First University Clinic Tbilisi
Georgia LTD Unimed Kakheti- Telavi Referral Hospital Telavi
Germany Klinikum Augsburg Augsburg
Germany Charite - Campus Mitte Berlin
Germany Krankenhaus Waldfriede Mitte Berlin
Germany Synexus Berlin Research Center Berlin
Germany Universitaetsklinikum Charite, Campus Virchow Klinikum Berlin
Germany Gastroenterologische Spezialpraxis - Berlin-Karlshorst Berlin-Karlshorst
Germany Klinikum Dresden Dresden
Germany JWG-University Hospital Frankfurt
Germany Synexus Clinical Research GmbH Frankfurt
Germany Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus Frankfurt/Main
Germany Asklepios Westklinikum Hamburg
Germany Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Universitaetsklinikum Heidelberg Heidelberg
Germany Universitatsklinikum Schleswig Holstein Kiel Kiel
Germany Eugastro GmbH Leipzig
Germany Gastroenterologie und Hepatologie am Johannisplatz Leipzig
Germany Staedtisches Klinikum Lueneburg Lueneburg
Germany Universitaetsklinikum Mannheim Mannheim
Germany Gemeinschaftspraxis Germania-Campus Münster
Germany Praxiszentrum Alte Mälzerei Regensburg
Germany Zentrum für Gastroenterologie Saar MVZ GmbH Saarbrücken
Germany Universitatsklinikum Ulm Ulm
Greece Laiko General Hospital of Athens Athens
Greece University Hospital of Heraklion Heraklion
Hungary Réthy Pál Kórház - Rendelointézet Békéscsaba
Hungary Meddica Centre Hungarian Defence Froces Budapest
Hungary Péterfy Sándor utcai Kórház Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Synexus Magyarorszag Kft Budapest
Hungary Synexus Magyarorszag Kft Gyula
Hungary Tolna Megyei Balassa Janos Korhaz Szekszárd
India Apex Hospitals Ltd Jaipur
India Fortis Hospital New Delhi
India Fortis Hospital Noida
India Shree Giriraj Multispeciality Hospital Rajkot
India BAPS Pramukhswami Hospital Surat
India Nirmal Hospital Pvt. Ltd. Surat
India Surat Institute of Digestive Sciences Hospitals Surat
India Unity Hospital Surat
Israel Ha'Emek Medical Center Afula
Israel Barzilai Medical Center Ashkelon
Israel Soroka Medical Center Bear Sheva
Israel Bnai Zion Medical Center Haifa
Israel Rambam Medical Center Haifa
Israel Hadassah Hebrew University Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Rabin Med Ctr Beilinson Hosp Petah Tikva
Israel Chaim Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Israel Assaf Harofeh Medical Center Tzrifin
Italy Policlinico S.Orsola Malpighi, AOU di Bologna Bologna
Italy Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato Cagliari
Italy Ospedale Santissima Annunziata Cento
Italy AOU Policlinico G.Martino Messina
Italy Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura Milano
Italy Universita degli Studi di Padova - Azienda Ospedaliera di Padova Padova
Italy Policlinico Universitario Agostino Gemelli Roma
Italy Università Campus Biomedico di Roma Roma
Italy Complesso Integrato Columbus Rome
Italy IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali Rozzano
Italy Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy S.C. Gastroenterologia Torino
Italy Azienda Ospedaliero Universitaria S.Maria Della Misericordia Udine
Italy Policlinico G.B.Rossi Verona
Japan Asahikawa City Hospital Asahikawa
Japan Juntendo University Hospital Bunkyo-ku
Japan Juntendo University Hospital Bunkyo-ku
Japan Chiba University Hospital Chiba
Japan Fukuoka University Chikushi Hospital Chikushino
Japan Fukuoka University Hospital Fukuoka-shi
Japan Saiseikai Fukuoka General Hospital Fukuoka-shi
Japan Gifu University Hospital Gifu
Japan Tokai University Hachioji Hospital Hachioji
Japan Matsuda Hospital Hamamatsu-shi
Japan Mito Medical Center - Digestive Organs Higashiibaraki-gun
Japan National Hospital Organization Hirosaki General Medical Center Hirosaki
Japan Hiroshima University Hospital Hiroshima
Japan Izumiotsu Municipal Hospital Izumiotsu
Japan Shimane University Hospital Izumo
Japan Kagoshima IBD Gastroenterology Clinic Kagoshima
Japan Nanpuh Hospital Kagoshima
Japan Sameshima Hospital Kagoshima
Japan Kanazawa University Hospital Kanazawa
Japan Nara Medical University Hospital Kashihara
Japan The Jikei University Hospital Kashiwa
Japan Tsujinaka Hospital Kashiwanoha Kashiwa
Japan Aoyama Naika Clinic Kobe
Japan Kobe University Hospital Kobe
Japan National Hospital Organization Kochi National Hospital Kochi
Japan Yamanashi Prefectural Central Hospital Kofu
Japan National Hospital Organization Kure Medical Center and Chugoku Cancer Center Kure
Japan Kurume University Hospital Kurume
Japan JRC Kyoto Daiichi Hospital Kyoto
Japan Kyoto University Hospital Kyoto
Japan National Hospital Organization Kyoto Medical Center Kyoto
Japan University Hospital Kyoto Perfectural University of Medicine Kyoto
Japan Kitasato University Kitasato Institute Hospital Minato-ku
Japan Kyorin University Hospital Mitaka
Japan Iwate Medical University Hospital Morioka
Japan Aichi Medical University Hospital Nagakute
Japan Nagaoka Red Cross Hospital Nagaoka
Japan Nagasaki University Hospital Nagasaki
Japan Nagoya City University Hospital Nagoya
Japan Nagoya University Hospital Nagoya
Japan The Hospital of Hyogo College of Medicine Nishinomiya
Japan JA Obihiro Kosei Hospital Obihiro
Japan Oita Red Cross Hospital Oita
Japan Okayama Saiseikai General Hospital Okayama
Japan Nakagami Hospital Okinawa
Japan Japanese Red Cross Osaka Hospital Osaka
Japan Kinshukai Infusion Clinic Osaka
Japan Kitano Hospital Osaka
Japan Osaka City University Hospital Osaka
Japan Kindai University Hospital Osaka-Sayama
Japan National Hospital Organization Osaka National Hospital Osaka-shi
Japan Osaki Citizen Hospital Osaki
Japan Shiga University of Medical Science Hospital Otsu
Japan National Hospital Organization Higashi Ohmi General Medical Center Otsu-shi
Japan Japan Community Health Care Organization Saitama Medical Center Saitama
Japan Saitama Medical University Hospital Saitama
Japan Tokitokai Tokito Clinic Coloproctology Center Saitama
Japan Toho University Sakura Medical Center Sakura
Japan JA Sapporo-Kosei General Hospital - 1st Digestive Organs Sapporo
Japan Sapporo Higashi Tokushukai Hospital Sapporo
Japan Sapporo IBD Clinic Sapporo Chuo-ku
Japan Hokkaido University Hospital Sapporo-shi
Japan Keio University Hospital Shinjuku-ku
Japan Tokyo Yamate Medical Center Shinjuku-ku
Japan Osaka University Hospital Suita-shi
Japan Kagawa Prefectural Central Hospital Takamatsu
Japan Takamatsu Red Cross Hospital Takamatsu
Japan Tokushima University Hospital Tokushima
Japan The Jikei University Hospital Tokyo
Japan Yuaikai Tomishiro Central Hospital Tomishiro
Japan Ehime University Hospital Toon
Japan Toyama City Hospital Toyama-shi
Japan Fujita Health University Hospital Toyoake
Japan Mie University Hospital Tsu
Japan Wakayama Medical University Hospital Wakayama
Japan Yokohama City University Medical Center Yokohama
Jordan Jordan University Hospital Amman
Jordan Khalidi Hospital and Medical Center Amman
Jordan Irbid Specialty Hospital Irbid
Jordan King Abdullah University Hospital Irbid
Korea, Republic of Korea University Ansan Hospital Ansan-si
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Kyongpook national university Medical center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of The Catholic university of Korea, St. Vincent's Hospital Gyeonggi-do
Korea, Republic of Hallym University Dongtan Sacred Heart Hospital Hwaseong-si
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam
Korea, Republic of The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital Seongnam
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Yonsei University College of Medicine Seoul
Korea, Republic of Wonju Christian Hospital Wonju
Korea, Republic of Ewha Womans University Mokdong Hospital YangCheon-Gu
Latvia Alda Pukisa arsta prakse Riga
Latvia Pauls Stradins Clinical University Hospital Riga
Lebanon Ain Wazein Hospital Ain Wazein
Lebanon American Universitty of Beirut Medical Center Beirut
Lebanon Bellevue Medical Center Beirut
Lebanon Hotel Dieu de France Hospital Beirut
Lebanon Mount Lebanon Hospital Beirut
Lebanon Rafik Hariri University Hospital Beirut
Lebanon St Georges Hospital university medical centre Beirut
Lebanon Nini Hospital Tripoli
Lithuania Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik Kaunas
Lithuania Vilnius University Hospital Santaros Klinikos, Public Institution Vilnius
Malaysia Hospital Ampang Ampang
Malaysia Hospital Raja Permaisuri Bainun Ipoh
Malaysia Hospital Sultanah Aminah Johor Bahru
Malaysia Hospital Raja Perempuan Zainab Ii Kota Bahru
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Hospital Tengku Ampuan Afzan Kuantan
Netherlands Amsterdam UMC locatie VUMC Amsterdam
Netherlands Academisch Ziekenhuis Maastricht Maastricht
Netherlands Stichting Zuyderland Medisch Centrum Sittard-Geleen
New Zealand Auckland City Hospital Auckland
New Zealand Christchurch Hospital Christchurch
New Zealand Dunedin Hospital Dunedin
New Zealand Waikato Hospital Hamilton
North Macedonia General City Hospital 8mi Septemvri Skopje
North Macedonia University Clinic of Gastroenterohepatology Skopje
Poland NZOZ Centrum Medyczne KERmed Bydgoszcz
Poland Centrum Medyczne Lukamed Chojnice
Poland Synexus Polska Sp. z o.o. Oddzial w Czestochowie Czestochowa
Poland Synexus Polska Sp. z o.o. Oddzial w Gdansku Gdansk
Poland Synexus Scm Sp. Z o.o. Oddzial Gdynia Gdynia
Poland Prywatna Praktyka Lekarska Jelenia Góra
Poland Synexus Polska Sp. z o.o. Oddzial w Katowicach Katowice
Poland Centrum Medyczne Plejady Krakow
Poland Centrum Medyczne Promed Krakow
Poland Malopolskie Centrum Kliniczne Krakow
Poland Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj Ksawerów
Poland AmiCare Centrum Medyczne Lodz
Poland Synexus Polska Sp. z o.o. Lodz
Poland 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie Lublin
Poland Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K. Lublin
Poland Wojewodzki Szpital Specjalistyczny w Olsztynie Olsztyn
Poland Twoja Przychodnia Opole
Poland Oswiecimskie Centrum Badan Klinicznych Oswiecim
Poland EMC Instytut Medyczny SA Poznan
Poland Solumed S.C. Poznan
Poland Synexus Polska Sp. z.o.o. Oddzial w Poznaniu Poznan
Poland Twoja Przychodnia Poznan
Poland Centrum Medyczne 'Medyk' Sp. z o.o. K. Rzeszow
Poland Endoskopia Sp z o.o. Sopot
Poland Kiepury Clinic Sosnowiec
Poland Niepubliczny Zaklad Opieki Zdrowotnej Szczecin
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin
Poland GASTROMED, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie Torun
Poland H-T Centrum Medyczne Endoterapia Tychy
Poland NZOZ Vivamed Zespol Lekarzy Specjalistow Warsaw
Poland Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa
Poland Centrum Badawcze Wspolczesnej Terapii Warszawa
Poland Centrum Medyczne Warszawa
Poland Synexus Polska Sp z o o Oddzial w Warszawie Warszawa
Poland Szpital Pomnik Centrum Zdrowia Dziecka Warszawa
Poland Wojskowy Instytut Medyczny Warszawa
Poland Centrum Zdrowia Tuchow Wierzchoslawice
Poland Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska Wloclawek
Poland ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c. Wroclaw
Poland EuroMediCare Szpital Specjalistyczny z Przychodnia Wroclaw
Poland Futuremeds sp. z o.o. Wroclaw
Poland Melita Medical Sp. z o.o. Wroclaw
Poland Przychodnia Vistamed Wroclaw
Poland Synexus Polska Sp z o o Oddzial we Wroclawiu Wroclaw
Poland ETG Zamosc Zamosc
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar e Universitário de Coimbra, EPE Coimbra
Portugal Hosp. Sra. Da Oliveira - Guimaraes Guimarães
Portugal Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio Portimao
Portugal H. Santo António - Centro Hospitalar do Porto Porto
Portugal Centro Hospitalar de Entre o Douro e Vouga, E.P.E Santa Maria da Feira
Puerto Rico San Juan Bautista School of Medicine Caguas
Russian Federation Kazan State Medical University Kazan
Russian Federation KGBUZ 'Regional Clinical Hospital' Krasnoyarsk
Russian Federation State Scientific Centre of Coloproctology Moscow
Russian Federation Novgorod Regional Clinical Hospital n.a. N.A. Semashko Nizhny Novgorod
Russian Federation City Clinical Hospital #12 Novosibirsk
Russian Federation FSBI 'Scientific Research Institute of Clinical and Experimental Lymphology' of Siberian Branch Novosibirsk
Russian Federation Clinical Diagnostic Center 'Ultramed' Omsk
Russian Federation GBUZ of Moscow Region City Clinical Hospital #3 Podolsk
Russian Federation GBOU VPO Rostov State Medical University Rostov-na-Donu
Russian Federation City Hospital #20 Rostov-on-Don
Russian Federation Clinical Hospital #122 n.a. after L.G. Sokolov Saint Petersburg
Russian Federation City Hospital named after St. Martyr Elizabeth Saint-Petersburg
Russian Federation The Limited Liability Company Research center Eco-safety Saint-Petersburg
Russian Federation Medical University Reaviz Samara
Russian Federation NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways' Samara
Russian Federation Saratov City Hospital #5 Saratov
Russian Federation St.Petersburg State Medical University n.a.Pavlov St Petersburg
Russian Federation City Clinical Hospital #31 St. Petersburg
Russian Federation Tomsk Regional Clinical Hospital Tomsk
Russian Federation Ulyanovsk Regional Clinical Hospital Ulyanovsk
Russian Federation GUZ Novgorod Regional Clinical Hospital Velikiy Novgorod
Saudi Arabia King Abdullah Medical City in Holy Capital Makkah
Saudi Arabia King Abdul Aziz Medical City for National Guard Health Affairs Riyadh
Serbia Clinical Hospital Center Bezanijska Kosa Belgrade
Serbia Special hospital for Internal diseases, Oncomed system Belgrade
Serbia University Clinical Center of Serbia Belgrade
Serbia Zvezdara University Medical Center Belgrade
Serbia University Clinical Center Kragujevac Kragujevac
Serbia General Hospital 'Djordje Joanovic' Zrenjanin
Slovakia FNsP F.D.R. Banska Bystrica Banska Bystrica
Slovakia ENDOMED s.r.o Kosice
Slovakia GASTRO I. s.r.o. Presov
Spain Hosp Reina Sofia Córdoba
Spain Complejo Hosp Univ. de Ferrol Ferrol
Spain Hosp. Univ. Dr. Josep Trueta Girona
Spain Hosp. Gral. Juan Ramon Jimenez Huelva
Spain Hosp. Univ. La Paz Madrid
Spain Hosp. Univ. Central de Asturias Oviedo
Spain Hosp. Provincial de Pontevedra Pontevedra
Spain Hosp. Virgen Del Rocio Sevilla
Spain Hosp. Univ. de Torrejon Torrejón de Ardoz
Spain Hosp. Alvaro Cunqueiro Vigo
Spain Hosp. Univ. Miguel Servet Zaragoza
Taiwan Chang-Hua Christian Hospital Changhua
Taiwan China Medical University Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang-Gung Memorial Hospital-Linkou Taoyuan
Tunisia Hopital Regional Mohamed Tahar El Maamouri Nabul
Tunisia Hopital Universitaire Sahloul Sousse
Tunisia Hopital Habib Thameur Tunis
Tunisia Military Hospital of Instruction of Tunis Tunis
Tunisia Hospital La Rabta Tunis Jebbari
Turkey Gulhane Egitim ve Arastirma Hastanesi Ankara
Turkey Hacettepe University Medical Faculty Ankara
Turkey Firat University Hospital Elazig
Turkey Mustafa Kemal University Research and Practise Hospital Hatay
Turkey Acibadem Fulya Hospital Istanbul
Turkey BAU Medical Park Goztepe Hospital Istanbul
Turkey Marmara University Medical Faculty Istanbul
Turkey Sisli Etfal Egitim ve Arastirma Hospital Istanbul
Turkey Dokuz Eylul University Medical Faculty Izmir
Ukraine MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council Kharkiv
Ukraine SE 'National institute therapy named L.T. Maloi NAMS of Ukraine' Kharkiv
Ukraine KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha Kherson
Ukraine KNP Kyivska miska klinichna likarnia ?18 vykonavchoho orhanu KMR (KMDA) Kyiv
Ukraine Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' Kyiv
Ukraine Kyiv Regional Clinical Hospital Kyiv
Ukraine LLC Treatment and Diagnostic Center Adonis Plus Kyiv
Ukraine Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud Kyiv
Ukraine Odeska oblasna klinichna likarnia Odesa
Ukraine Ternopil municipal hospital #1 Ternopil
Ukraine MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council Uzhgorod
Ukraine Health Clinic Limited Liability Company Vinnytsia
Ukraine KU 6 miska klinichna likarnia ZMR Zaporozhye
United Kingdom Barnsley District General Hospital Barnsley
United Kingdom Addenbrooke's Hospital Cambridge
United Kingdom St George's Healthcare NHS Trust London
United States Advanced Research Center Inc Anaheim California
United States Synexus Clinical Research US Inc Anderson South Carolina
United States Asheville Gastroenterology Associates Asheville North Carolina
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Emory University Atlanta Georgia
United States Morehouse School of Medicine Atlanta Georgia
United States Woodholme Gastroenterology Associates Baltimore Maryland
United States Gastroenterology Associates Baton Rouge Louisiana
United States Clinical Inquest Center, LTD Beavercreek Ohio
United States Northwest Gastroenterology Associates - USA Bellevue Washington
United States Paul Wallace MD Beverly Hills California
United States University North Carolina at Chapel Hill Chapel Hill North Carolina
United States Charlotte Gastroenterology and Hepatology, PLLC Charlotte North Carolina
United States Onsite Clinical Solutions Charlotte North Carolina
United States Memorial Health Care System Chattanooga Tennessee
United States Digestive Health Specialists PC Chelmsford Massachusetts
United States Gastroenterology Associates of Tidewater Chesapeake Virginia
United States Clinical Research Institute of Michigan, LLC Chesterfield Michigan
United States Pioneer Research Solutions Inc. Coconut Creek Florida
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Ohio State University Columbus Ohio
United States Synexus Clinical Research US Inc Columbus Ohio
United States Atlanta Center For Gastroenterology Decatur Georgia
United States Digestive Health Specialists of the Southeast Dothan Alabama
United States Cumberland Research Associates Fayetteville North Carolina
United States InvesClinic, LLC Fort Lauderdale Florida
United States DHAT Research Institute Garland Texas
United States Gastro One Germantown Tennessee
United States Gastroenterology Associates P.A. Greenville South Carolina
United States Harmony Medical Research Institute, Inc. Hialeah Florida
United States Baylor College of Medicine Houston Texas
United States CliniCore Houston Houston Texas
United States Houston Digestive Diseases Consultants Houston Texas
United States Houston Methodist Hospital Houston Texas
United States IU Health University Hospital Indianapolis Indiana
United States Elite Research Network - Nature Coast Clinical Research, LLC Inverness Florida
United States A1 Clinical Research Jackson Heights New York
United States Tennessee State University Johnson Tennessee
United States Care Access Research, Kinston Kinston North Carolina
United States SIH Research Kissimmee Florida
United States University Of California San Diego La Jolla California
United States Gastroenterology Clinic of Acadiana Lafayette Louisiana
United States Auzmer Research Lakeland Florida
United States Florida Research Center Inc. Lakewood Ranch Florida
United States Om Research LLC Lancaster California
United States Las Vegas Medical Research Las Vegas Nevada
United States BVL Clinical Research Leawood Kansas
United States Caprock Gastro Research Lubbock Texas
United States Tandem Clinical Research Marrero Louisiana
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States Community Research Foundation, Inc. Miami Florida
United States Homestead Associates in Research Inc Miami Florida
United States Sanchez Clinical Research, Inc Miami Florida
United States Visionary Investigators Network Miami Florida
United States Allameh Medical Corp Mission Viejo California
United States Internal Medicine Center Mobile Alabama
United States Atlantic Digestive Health Institute/ Atlantic IBD Center Morristown New Jersey
United States Clinical Trials of America Mount Airy North Carolina
United States United Gastroenterologists Murrieta California
United States Gastroenterology Group Of Naples Naples Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States DelRicht Research New Orleans Louisiana
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Care Access Research New York New York
United States New York Gastroenterology Associates New York New York
United States NYU Langone Medical Center New York New York
United States Weill Cornell Medical College New York New York
United States Integris Baptist Office Oklahoma City Oklahoma
United States Clinnova Research Orange California
United States Care Access Research, Orlando Orlando Florida
United States Florida Hospital Orlando Florida
United States Omega Research Consultants Orlando Florida
United States Center for Gastrointestinal Health Petersburg Virginia
United States Synexus Clinical Research US Inc Pinellas Park Florida
United States Southwoods Health Poland Ohio
United States Health Science Research Center Pratt Kansas
United States Inland Empire Liver Foundation Rialto California
United States Gastroenterology Consultants of Southwest Virginia Roanoke Virginia
United States University of Rochester Medical Center Rochester New York
United States Gastroenterology Consultants Roswell Georgia
United States UC Davis Medical Center Sacramento California
United States Central Florida Internists Saint Cloud Florida
United States Synergy Clinical Research Saint Petersburg Florida
United States Theia Clincial Research, LLC Saint Petersburg Florida
United States Gastroenterology Clinic Of San Antonio P A San Antonio Texas
United States Gastroenterology Research of America, LLC San Antonio Texas
United States UT Health Science Center at San Antonio San Antonio Texas
United States Clinical Applications Laboratories, Inc San Diego California
United States Louisiana Research Center, LLC Shreveport Louisiana
United States LSUHSC Shreveport Feist-Weiller Cancer Center Shreveport Louisiana
United States Texas Digestive Disease Consultants Southlake Texas
United States Texas Gastroenterology Associates - Research Spring Texas
United States Atlanta Gastroenterology Specialists PC Suwanee Georgia
United States Syracuse VA Medical Center Syracuse New York
United States Washington Gastroenterology, PLLC Tacoma Washington
United States Alliance Clinical Research Tampa Florida
United States Clinical Research of West Florida Tampa Florida
United States Florida Hospital Tampa Tampa Florida
United States GCP Clinical Research Tampa Florida
United States Baylor Scott & White Research Institute Temple Texas
United States Cotton O'Neil Digestive Health Center Topeka Kansas
United States University of Arizona Tucson Arizona
United States Tyler Research Institute, LLC Tyler Texas
United States Carle Foundation Hospital Urbana Illinois
United States Northshore Gastroenterology Research, LLC Westlake Ohio
United States Cleveland Clinic Florida Weston Florida
United States PMG Research of Winston-Salem Winston-Salem North Carolina
United States US Digestive Health Wyomissing Pennsylvania
United States Huron Gastroenterology Associates Center for Digestive Care Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belarus,  Belgium,  Bosnia and Herzegovina,  Brazil,  Canada,  China,  Colombia,  Croatia,  Czechia,  France,  Georgia,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Jordan,  Korea, Republic of,  Latvia,  Lebanon,  Lithuania,  Malaysia,  Netherlands,  New Zealand,  North Macedonia,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  Spain,  Taiwan,  Tunisia,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity. Baseline and Week 12
Primary Phase 3: Clinical Response at Week 12 and Clinical Remission at Week 48 Clinical response and clinical remission based on CDAI score. Baseline to Week 48
Primary Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48 Clinical response based on CDAI score and endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD). Baseline to Week 48
Secondary Phase 2: Clinical Remission at Week 12 Clinical remission is defined as CDAI score <150. Week 12
Secondary Phase 2: Clinical Response at Week 12 Clinical response is defined as >= 100-point reduction from baseline in CDAI score or CDAI score <150. Week 12
Secondary Phase 2 and Phase 3: Patient-Reported Outcome (PRO)-2 Remission at Week 12 PRO-2 remission is defined based on average daily stool frequency (SF), average daily abdominal pain (AP) score and no worsening of AP or SF from baseline. Week 12
Secondary Phase 2: Clinical-Biomarker Response at Week 12 Clinical-biomarker response is defined using clinical response based on the CDAI score and reduction from baseline in C-reactive protein (CRP) or fecal calprotectin. Week 12
Secondary Phase 2: Endoscopic Response at Week 12 Endoscopic Response is measured by the SES-CD. The SES-CD is based on the evaluation of 4 endoscopic components across 5 ileocolonic segments, with a total score ranging from 0 to 56. Week 12
Secondary Phase 3: Clinical Response at Week 4 Clinical response based on CDAI score. Week 4
Secondary Phase 3: Clinical Remission at Week 12 Clinical remission based on CDAI score. Week 12
Secondary Phase 3: Endoscopic Response at Week 12 Endoscopic response based on SES-CD score. Week 12
Secondary Phase 3: Fatigue Response at Week 12 Fatigue response will be based on the Patient-Reported Outcomes Measurement Information System (PROMIS). Week 12
Secondary Phase 3: Clinical Remission at Week 12 and Endoscopic Response at Week 12 Clinical remission based on CDAI score and endoscopic response based on SES-CD score. Week 12
Secondary Phase 3: Endoscopic Remission at Week 12 Endoscopic remission based on SES-CD score. Week 12
Secondary Phase 3: Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48 Clinical response based on CDAI score; corticosteroid-free clinical remission based on CDAI score and corticosteroid concomitant medications. Baseline to Week 48
Secondary Phase 3:Clinical Response at Week 12 and Endoscopic Remission at Week 48 Clinical response based on CDAI and endoscopic remission based on SES-CD. Baseline to Week 48
Secondary Phase 3: Clinical Remission at Week 48 Clinical remission based on CDAI score. Week 48
Secondary Phase 3: Endoscopic Response at Week 48 Endoscopic response based on SES-CD. Week 48
Secondary Phase 3: Clinical Remission at Week 48 and Endoscopic Response at Week 48 Clinical remission based on CDAI score and endoscopic response based on SES-CD score. Week 48
Secondary Phase 3: Endoscopic Remission at Week 48 Endoscopic remission based on SES-CD score. Week 48
Secondary Phase 3: Deep Remission at Week 48 Deep remission is defined as clinical remission and endoscopic remission. Week 48
See also
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