A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
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
Sites / Locations
- Digestive Health Specialists of the Southeast
- Internal Medicine Center
- University of Arizona
- Advanced Research Center Inc
- Paul Wallace MD
- University Of California San Diego
- Om Research LLC
- Allameh Medical Corp
- United Gastroenterologists
- Clinnova Research
- Inland Empire Liver Foundation
- UC Davis Medical Center
- Clinical Applications Laboratories, Inc
- Peak Gastroenterology Associates
- Pioneer Research Solutions Inc.
- InvesClinic, LLC
- Harmony Medical Research Institute, Inc.
- Elite Research Network - Nature Coast Clinical Research, LLC
- SIH Research
- Auzmer Research
- Florida Research Center Inc.
- Homestead Associates in Research, Inc
- Community Research Foundation, Inc.
- Sanchez Clinical Research, Inc
- Visionary Investigators Network
- Gastroenterology Group Of Naples
- Florida Hospital
- Omega Research Consultants
- Care Access Research, Orlando
- Synexus Clinical Research US, Inc
- Central Florida Internists
- Synergy Clinical Research
- Theia Clincial Research, LLC
- Clinical Research of West Florida
- GCP Clinical Research
- Florida Hospital Tampa
- Alliance Clinical Research
- Cleveland Clinic Florida
- Atlanta Gastroenterology Associates
- Morehouse School of Medicine
- Emory University
- Atlanta Center For Gastroenterology
- Gastroenterology Consultants
- Atlanta Gastroenterology Specialists PC
- Northwestern University
- Carle Foundation Hospital
- IU Health University Hospital
- BVL Clinical Research
- Health Science Research Center
- Cotton O'Neil Digestive Health Center
- Gastroenterology Associates
- Gastroenterology Clinic of Acadiana
- Tandem Clinical Research
- Ochsner Clinic Foundation
- DelRicht Research
- LSUHSC Shreveport Feist-Weiller Cancer Center
- Louisiana Research Center, LLC
- Woodholme Gastroenterology Associates
- Digestive Health Specialists PC
- Clinical Research Institute of Michigan, LLC
- Huron Gastroenterology Associates Center for Digestive Care
- Las Vegas Medical Research
- Atlantic Digestive Health Institute/ Atlantic IBD Center
- A1 Clinical Research
- Crystal Run Healthcare
- Weill Cornell Medical College
- New York Gastroenterology Associates
- Care Access Research
- NYU Langone Medical Center
- University of Rochester Medical Center
- Syracuse VA Medical Center
- Asheville Gastroenterology Associates
- University North Carolina at Chapel Hill
- Charlotte Gastroenterology and Hepatology, PLLC
- Onsite Clinical Solutions
- Cumberland Research Associates
- Care Access Research, Kinston
- Clinical Trials of America
- PMG Research of Winston-Salem
- Clinical Inquest Center, LTD
- Ohio State University
- Synexus Clinical Research US, Inc
- Great Lakes Gastroenterology Research, LLC
- Southwoods Health
- Northshore Gastroenterology Research, LLC
- Integris Baptist Office
- US Digestive Health
- Synexus Clinical Research US, Inc
- Gastroenterology Associates P.A.
- Memorial Health Care System
- Gastro One
- Tennessee State University
- Vanderbilt University Medical Center
- DHAT Research Institute
- Baylor College of Medicine
- Houston Methodist Hospital
- Houston Digestive Diseases Consultants
- CliniCore Houston
- Caprock Gastro Research
- Gastroenterology Clinic Of San Antonio P A
- Gastroenterology Research of America, LLC
- UT Health Science Center at San Antonio
- Texas Digestive Disease Consultants
- Texas Gastroenterology Associates - Research
- Baylor Scott & White Research Institute
- Tyler Research Institute, LLC
- Gastroenterology Associates of Tidewater
- Center for Gastrointestinal Health
- Gastroenterology Consultants of Southwest Virginia
- Northwest Gastroenterology Associates - USA
- Washington Gastroenterology, PLLC
- The Queen Elizabeth Hospital
- Monash Health, Monash Medical Centre
- Concord Hospital
- Austin Hospital
- Sir Charles Gairdner Hospital
- Royal Adelaide Hospital
- Royal Melbourne Hospital
- Nepean Hospital
- The Alfred Hospital
- Mater Hospital Brisbane
- Princess Alexandra Hospital
- Universitätsklinikum Salzburg - Landeskrankenhaus
- Akh Wien
- Gomel Regional Clinical Hospital
- Republican Research Centre of Radiation Medicine and Human E
- Grodno University Hospital
- Healthcare Institution,Minsk Scientific center for surgery,
- Vitebsk Regional Clinical Hospital
- AZ Klina
- CHU Saint-Pierre
- Hopital Erasme
- UZ Gent
- Az Groeninge
- Algemeen Ziekenhuis Delta
- CHwapi
- University Clinical Centre of the Republic of Srpska
- Clinical hospital Mostar
- Clinical Center University of Sarajevo
- Polyclinic Dr. Al-Tawil
- Cantonal Hospital Zenica
- MK Blumenau Pesquisa Clínica
- Universidade Estadual Paulista 'Julio De Mesquita Filho'
- L2IP - Instituto de Pesquisas Clinicas
- Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
- Hospital Nossa Senhora Das Gracas
- Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
- Centro de Estudos Clínicos do Interior Paulista - CECIP
- CMIP - Centro Mineiro de Pesquisa Ltda
- Complexo Hospitalar de Niterói
- Instituto Mederi de Pesquisa e Saude
- Hospital das Clinicas de Porto Alegre
- Instituto do Aparelho Digestivo
- Universidade Federal do Rio de Janeiro - Faculdade de Medicina
- Hospital Santa Izabel
- Pesquisare Saude
- Praxis pesquisa médica
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
- Irmandade da Santa Casa da Misericórdia de Santos
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
- Hemomed
- BR Trials
- Kaiser Hospta
- CPCLIN - Centro de Pesquisas Clínicas
- Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
- University of Calgary
- Gastroenterology and Internal Medicine Research Institute (GIRI)
- University of Alberta- Ziedler Ledcor Centre
- Columbia Gastroenterology
- Health Sciences Centre
- Barrie GI Associates
- London Health Sciences Centre
- Mount Sinai Hospital-Toronto
- Pharmaceutical Integrated Research Company
- MUHC Montreal General Hospital
- Royal University Hospital
- Peking University First Hospital
- Beijing Friendship Hospital
- Peking University Third Hospital
- The Military General Hospital of Beijing PLA
- The second Xiangya Hospital of Central South University
- Changzhou No.2 People's Hospital
- West China Hospital, Sichuan University
- The Second Affiliated Hospital of Chongqing Medical University
- First Affiliated Hospital of Gannan Medical University
- The First Affiliated Hospital Sun Yat-Sen University
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
- ZhuJiang Hospital of Southern Medical University
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
- The Second Affiliated Hospital of Zhejiang University
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- The 1st affiliated hospital of Anhui Medical University
- Huai'an 1st Hospital
- The First Affiliated Hospital of NanChang University
- Nanjing Drum Tower Hospital
- Zhongda Hospital,Southeast University
- Shanghai Ninth People's Hospital
- Huashan Hospital Fudan University
- Second Military Medical University (SMMU)
- Tongji Hospital of Tongji University
- Ruijin Hospital, Shanghai Jiao Tong University
- Shengjing Hospital of China Medical University
- Peking University Shenzhen Hospital
- The first affiliated hospital of suzhou University
- The First Affiliated Hospital of Wenzhou Medical University
- Wuhan Union Hospital
- Renmin Hospital of Wuhan University
- Wuxi People's Hospital
- Zhongshan Hospital, Xiamen University
- Yangzhou First People's Hospital
- Zhangzhou Municipal Hospital of Fujian Province
- Medplus Medicina Prepagada S.A.
- Clinica de la Mujer
- Endocare Ltda.
- Centro Médico Imbanaco
- Corporacion para Estudios en Salud Clinica CES - Gastroenterology
- Hospital Pablo Tobon Uribe
- Opca bolnica Bjelovar
- Opca bolnica Zadar
- CH Sestre Milosrdnice
- Poliklinika Solmed
- University Hospital Center Zagreb
- University Hospital Dubrava
- Nemocnice Ceske Budejovice
- NH Hospital, a.s.
- Hepato-gastroenterologie HK, s.r.o.
- Synexus Czech s.r.o.
- Fakultni nemocnice Kralovske Vinohrady
- ISCARE a.s.
- CHU Amiens
- Centre Hospitalier de la Cote Basque
- CHRU Besançon -Hôpital Jean Minjoz
- Centre Hospitalier Universitaire (CHU) de Caen
- CHRU de Tours - Hopital Trousseau
- Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
- CHU Grenoble
- CHRU de Lille - Hopital Claude Huriez
- Hopital Nord - Marseille
- CHRU Montpellier - Hopital Saint-Eloi
- CHU de Nantes hotel-Dieu
- CHU de Nice Hopital de l Archet
- CHU Nimes - Hôpital Carémeau
- Hôpital Bichat
- Groupement Hospitalier Universitaire Ouest
- Centre Hospitalier Lyon Sud
- Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
- CHU Saint-etienne
- Hopital D'Instruction Des Armees
- Centre Hospitalier Yves Le Foll
- CHRU de Strasbourg - Hopital de Hautepierre
- CHU Toulouse - Hopital de Rangueil
- Hopital Rangueil
- CHU de Nancy_ Hopital Brabois
- LTD 'Aversi Clinic'
- TSMU The First University Clinic
- Institute of Clinical Cardiology, Ltd.
- LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital'
- LTD Helsicore
- LTD Unimed Kakheti- Telavi Referral Hospital
- Klinikum Augsburg
- Gastroenterologische Spezialpraxis - Berlin-Karlshorst
- Charité - Campus Mitte
- Synexus Berlin Research Center
- Universitaetsklinikum Charite, Campus Virchow Klinikum
- Krankenhaus Waldfriede Mitte
- Klinikum Dresden
- Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
- Synexus Clinical Research GmbH
- JWG-University Hospital
- Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
- Asklepios Westklinikum
- Medizinische Hochschule Hannover
- Universitaetsklinikum Heidelberg
- Universitatsklinikum Schleswig-Holstein - Kiel
- Eugastro GmbH
- Gastroenterologie und Hepatologie am Johannisplatz
- Staedtisches Klinikum Lueneburg
- Universitaetsklinikum Mannheim
- Gemeinschaftspraxis Germania-Campus
- Praxiszentrum Alte Mälzerei
- Zentrum für Gastroenterologie Saar MVZ GmbH
- Universitatsklinikum Ulm
- Laiko General Hospital of Athens
- University Hospital of Heraklion
- Synexus Magyarorszag Kft.
- Péterfy Sándor utcai Kórház
- Meddica Centre Hungarian Defence Froces
- Semmelweis Egyetem
- Réthy Pál Kórház - Rendelőintézet
- Synexus Magyarorszag Kft
- Tolna Megyei Balassa János Kórház
- Apex Hospitals Ltd
- Fortis Hospital
- Fortis Hospital
- Shree Giriraj Multispeciality Hospital
- Nirmal Hospital Pvt. Ltd.
- Surat Institute of Digestive Sciences Hospitals
- BAPS Pramukhswami Hospital
- Unity Hospital
- Ha'Emek Medical Center
- Barzilai Medical Center
- Soroka Medical Center
- Rambam Medical Center
- Bnai Zion Medical Center
- Shaare Zedek Medical Center
- Hadassah Hebrew University Medical Center
- Meir Medical Center
- Rabin Med Ctr Beilinson Hosp
- Chaim Sheba Medical Center
- Tel Aviv Sourasky Medical Center
- Assaf Harofeh Medical Center
- Policlinico S.Orsola Malpighi, AOU di Bologna
- Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
- Ospedale Santissima Annunziata
- AOU Policlinico G.Martino
- Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura
- Universita degli Studi di Padova - Azienda Ospedaliera di Padova
- Università Campus Biomedico di Roma
- Policlinico Universitario Agostino Gemelli
- Complesso Integrato Columbus
- IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
- Casa Sollievo della Sofferenza
- S.C. Gastroenterologia
- Azienda Ospedaliero Universitaria S.Maria Della Misericordia
- Policlinico G.B.Rossi
- Asahikawa City Hospital
- Juntendo University Hospital
- Juntendo University Hospital
- Chiba University Hospital
- Fukuoka University Chikushi Hospital
- Saiseikai Fukuoka General Hospital
- Fukuoka University Hospital
- Gifu University Hospital
- Matsuda Hospital
- Mito Medical Center - Digestive Organs
- National Hospital Organization Hirosaki General Medical Center
- Hiroshima University Hospital
- Tokai University Hospital
- Izumiotsu Municipal Hospital
- Shimane University Hospital
- Kagoshima IBD Gastroenterology Clinic
- Sameshima Hospital
- Nanpuh Hospital
- Kanazawa University Hospital
- Nara Medical University Hospital
- Tsujinaka Hospital Kashiwanoha
- The Jikei University Hospital
- Aoyama Naika Clinic
- Kobe University Hospital
- National Hospital Organization Kochi National Hospital
- Yamanashi Prefectural Central Hospital
- National Hospital Organization Kure Medical Center and Chugoku Cancer Center
- Kurume University Hospital
- University Hospital Kyoto Perfectural University of Medicine
- JRC Kyoto Daiichi Hospital
- Kyoto University Hospital
- National Hospital Organization Kyoto Medical Center
- Kitasato University Kitasato Institute Hospital
- Kyorin University Hospital
- Osaki Citizen Hospital
- Iwate Medical University Hospital
- Aichi Medical University Hospital
- Nagaoka Red Cross Hospital
- Nagasaki University Hospital
- Nagoya University Hospital
- Nagoya City University Hospital
- The Hospital of Hyogo College of Medicine
- JA Obihiro Kosei Hospital
- Oita Red Cross Hospital
- Okayama Saiseikai General Hospital
- Nakagami Hospital
- Kindai University Hospital
- National Hospital Organization Osaka National Hospital
- Kinshukai Infusion Clinic
- Kitano Hospital
- Japanese Red Cross Osaka Hospital
- Osaka City University Hospital
- National Hospital Organization Higashi Ohmi General Medical Center
- Shiga University of Medical Science Hospital
- Japan Community Health Care Organization Saitama Medical Center
- Tokitokai Tokito Clinic Coloproctology Center
- Saitama Medical University Hospital
- Toho University Sakura Medical Center
- Sapporo IBD Clinic
- Hokkaido University Hospital
- JA Sapporo-Kosei General Hospital - 1st Digestive Organs
- Sapporo Higashi Tokushukai Hospital
- Keio University Hospital
- Tokyo Yamate Medical Center
- Osaka University Hospital
- Takamatsu Red Cross Hospital
- Kagawa Prefectural Central Hospital
- Tokushima University Hospital
- The Jikei University Hospital
- Yuaikai Tomishiro Central Hospital
- Ehime University Hospital
- Toyama City Hospital
- Fujita Health University Hospital
- Mie University Hospital
- Wakayama Medical University Hospital
- Yokohama City University Medical Center
- Khalidi Hospital and Medical Center
- Istishari Hospital
- Jordan University Hospital
- Irbid Specialty Hospital
- King Abdullah University Hospital
- Korea University Ansan Hospital
- Inje University Haeundae Paik Hospital
- Dong-A University Hospital
- Kyongpook national university Medical center
- Kyungpook National University Hospital
- The Catholic university of Korea, St. Vincent's Hospital
- Hallym University Dongtan Sacred Heart Hospital
- Seoul National University Bundang Hospital
- CHA Bundang Medical Center, CHA University
- The Catholic Univ. of Korea, DaeJeon St. Mary's Hospital
- Kangbuk Samsung Hospital
- Yonsei University College of Medicine
- Asan Medical Center
- Samsung Medical Center
- Chung-Ang University Hospital
- Gangnam Severance Hospital
- Wonju Christian Hospital
- Ewha Womans University Mokdong Hospital
- Pauls Stradins Clinical University Hospital
- Alda Pukisa arsta prakse
- Ain Wazein Hospital
- American Universitty of Beirut Medical Center
- St Georges Hospital university medical centre
- Hotel Dieu de France Hospital
- Bellevue Medical Center
- Mount Lebanon Hospital
- Rafik Hariri University Hospital
- Nini Hospital
- Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
- Vilnius University Hospital Santaros Klinikos, Public Institution
- Hospital Ampang
- Hospital Raja Permaisuri Bainun
- Hospital Sultanah Aminah
- Hospital Raja Perempuan Zainab Ii
- University Malaya Medical Centre
- Hospital Tengku Ampuan Afzan
- Academisch Medisch Centrum Universiteit van Amsterdam
- Academisch Ziekenhuis Maastricht
- Stichting Zuyderland Medisch Centrum
- Auckland City Hospital
- Christchurch Hospital
- Dunedin Hospital
- Waikato Hospital
- General City Hospital 8mi Septemvri
- University Clinic of Gastroenterohepatology
- NZOZ Centrum Medyczne KERmed
- Centrum Medyczne Lukamed
- Synexus Polska Sp. z o.o. Oddzial w Czestochowie
- Synexus Polska Sp. z o.o. Oddzial w Gdansku
- Synexus Scm Sp. Z o.o. Oddzial Gdynia
- Prywatna Praktyka Lekarska
- Synexus Polska Sp. z o.o. Oddzial w Katowicach
- Malopolskie Centrum Kliniczne
- Centrum Medyczne Plejady
- Centrum Medyczne Promed
- Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj
- Synexus Polska Sp. z o.o.
- AmiCare Centrum Medyczne
- 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
- Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
- Wojewodzki Szpital Specjalistyczny w Olsztynie
- Twoja Przychodnia
- Oswiecimskie Centrum Badan Klinicznych
- EMC Instytut Medyczny SA
- Solumed S.C.
- Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
- Twoja Przychodnia
- Centrum Medyczne 'Medyk' Sp. z o.o. K.
- Endoskopia Sp z o.o.
- Kiepury Clinic
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- Niepubliczny Zaklad Opieki Zdrowotnej
- GASTROMED, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie
- H-T Centrum Medyczne Endoterapia
- NZOZ Vivamed Zespol Lekarzy Specjalistow
- Wojskowy Instytut Medyczny
- Centralny Szpital Kliniczny MSWiA w Warszawie
- Centrum Medyczne
- Centrum Badawcze Wspolczesnej Terapii
- Szpital Pomnik Centrum Zdrowia Dziecka
- Synexus Polska Sp. z o.o. Oddzial w Warszawie
- Centrum Zdrowia Tuchow
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
- Futuremeds sp. z o.o.
- Melita Medical Sp. z o.o.
- Przychodnia Vistamed
- ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c.
- EuroMediCare Szpital Specjalistyczny z Przychodnia
- Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- ETG Zamosc
- Hospital de Braga
- Centro Hospitalar e Universitário de Coimbra, EPE
- Hosp. Sra. Da Oliveira - Guimaraes
- Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
- H. Santo António - Centro Hospitalar do Porto
- Centro Hospitalar de Entre o Douro e Vouga, E.P.E
- San Juan Bautista School of Medicine
- Kazan State Medical University
- KGBUZ 'Regional Clinical Hospital'
- State Scientific Centre of Coloproctology
- Novgorod Regional Clinical Hospital n.a. N.A. Semashko
- City Clinical Hospital #12
- FSBI 'Scientific Research Institute of Clinical and Experimental Lymphology' of Siberian Branch
- Clinical Diagnostic Center 'Ultramed'
- GBUZ of Moscow Region City Clinical Hospital #3
- GBOU VPO Rostov State Medical University
- City Hospital #20
- Clinical Hospital #122 n.a. after L.G. Sokolov
- City Hospital named after St. Martyr Elizabeth
- The Limited Liability Company Research center Eco-safety
- Medical University Reaviz
- NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
- Saratov City Hospital #5
- St.Petersburg State Medical University n.a.Pavlov
- City Clinical Hospital #31
- Tomsk Regional Clinical Hospital
- Ulyanovsk Regional Clinical Hospital
- GUZ Novgorod Regional Clinical Hospital
- King Abdullah Medical City in Holy Capital
- King Abdul Aziz Medical City for National Guard Health Affairs
- Special hospital for Internal diseases, Oncomed system
- University Clinical Center of Serbia
- Zvezdara University Medical Center
- Clinical Hospital Center Bezanijska Kosa
- University Clinical Center Kragujevac
- General Hospital 'Djordje Joanovic'
- FNsP F.D.R. Banska Bystrica
- ENDOMED s.r.o
- GASTRO I. s.r.o.
- Hosp. Reina Sofia
- Complejo Hosp Univ. de Ferrol
- Hosp. Univ. Dr. Josep Trueta
- Hosp. Gral. Juan Ramon Jimenez
- Hosp. Univ. La Paz
- Hosp. Univ. Central de Asturias
- Hosp. Provincial de Pontevedra
- Hosp. Virgen Del Rocio
- Hosp. Univ. de Torrejon
- Hosp. Alvaro Cunqueiro
- Hosp. Univ. Miguel Servet
- Chang-Hua Christian Hospital
- China Medical University Hospital
- National Taiwan University Hospital
- Chang-Gung Memorial Hospital-Linkou
- Hopital Regional Mohamed Tahar El Maamouri
- Hopital Universitaire Sahloul
- Hospital La Rabta
- Hopital Habib Thameur
- Military Hospital of Instruction of Tunis
- Cukurova University Medical Faculty Balcali Hospital
- Hacettepe University Medical Faculty
- Gulhane Egitim ve Arastirma Hastanesi
- Firat University Hospital
- Mustafa Kemal University Research and Practise Hospital
- Istanbul University Istanbul Medical Faculty
- Acibadem Fulya Hospital
- Sisli Etfal Egitim ve Arastirma Hospital
- BAU Medical Park Goztepe Hospital
- Marmara University Medical Faculty
- Dokuz Eylul University Medical Faculty
- MNCE'City Clinical Hospital №2 named after prof. O.O. Shalimov' of the Kharkiv City Council
- SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'
- KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha
- KNP Kyivska miska klinichna likarnia №18 vykonavchoho orhanu KMR (KMDA)
- LLC Treatment and Diagnostic Center Adonis Plus
- Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
- Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
- Kyiv Regional Clinical Hospital
- Odeska oblasna klinichna likarnia
- Ternopil municipal hospital #1
- MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
- Health Clinic Limited Liability Company
- KU 6 miska klinichna likarnia ZMR
- Barnsley District General Hospital
- Addenbrooke's Hospital
- St. Mark's Hospital
- St George's Healthcare NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
Phase 2 (GALAXI 1): Group 2 (Guselkumab)
Phase 2 (GALAXI 1): Group 3 (Guselkumab)
Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.
Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.
Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.
Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.
Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.
Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.