A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT03466411
Last Updated: 2025-11-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
1409 participants
INTERVENTIONAL
2018-04-13
2028-01-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 2 (GALAXI 1): Group 1 (Guselkumab)
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.
Guselkumab Dose 1
Guselkumab will be administered by IV infusion.
Guselkumab Dose 2
Guselkumab will be administered by SC injection.
Phase 2 (GALAXI 1): Group 2 (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.
Guselkumab Dose 2
Guselkumab will be administered by SC injection.
Guselkumab Dose 3
Guselkumab will be administered by IV infusion.
Phase 2 (GALAXI 1): Group 3 (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.
Guselkumab Dose 4
Guselkumab will be administered by IV infusion.
Guselkumab Dose 5
Guselkumab will be by SC injection.
Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
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.
Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.
Phase 2 (GALAXI 1): Group 5 (Placebo/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.
Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.
Placebo
Placebo will be administered as IV infusion.
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
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.
Guselkumab
Guselkumab will be administered by IV infusion and SC injection.
Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
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.
Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.
Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/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.
Ustekinumab
Ustekinumab will be administered by IV infusion and SC injection.
Placebo
Placebo will be administered as IV infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Internal Medicine Center
Mobile, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Advanced Research Center Inc
Anaheim, California, United States
Paul Wallace MD
Beverly Hills, California, United States
University Of California San Diego
La Jolla, California, United States
Om Research LLC
Lancaster, California, United States
Allameh Medical Corp
Mission Viejo, California, United States
United Gastroenterologists
Murrieta, California, United States
Clinnova Research
Orange, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Clinical Applications Laboratories, Inc
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Pioneer Research Solutions Inc.
Coconut Creek, Florida, United States
InvesClinic, LLC
Fort Lauderdale, Florida, United States
Harmony Medical Research Institute, Inc.
Hialeah, Florida, United States
Elite Research Network - Nature Coast Clinical Research, LLC
Inverness, Florida, United States
SIH Research
Kissimmee, Florida, United States
Auzmer Research
Lakeland, Florida, United States
Florida Research Center Inc.
Lakewood Rch, Florida, United States
Homestead Associates in Research Inc
Miami, Florida, United States
Community Research Foundation, Inc.
Miami, Florida, United States
Sanchez Clinical Research, Inc
Miami, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Gastroenterology Group Of Naples
Naples, Florida, United States
Florida Hospital
Orlando, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
Care Access Research, Orlando
Orlando, Florida, United States
Synexus Clinical Research US Inc
Pinellas Park, Florida, United States
Central Florida Internists
Saint Cloud, Florida, United States
Synergy Clinical Research
St. Petersburg, Florida, United States
Theia Clincial Research, LLC
St. Petersburg, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Florida Hospital Tampa
Tampa, Florida, United States
Alliance Clinical Research
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Atlanta Center For Gastroenterology
Decatur, Georgia, United States
Gastroenterology Consultants
Roswell, Georgia, United States
Atlanta Gastroenterology Specialists PC
Suwanee, Georgia, United States
Carle Foundation Hospital
Urbana, Illinois, United States
IU Health University Hospital
Indianapolis, Indiana, United States
BVL Clinical Research
Leawood, Kansas, United States
Health Science Research Center
Pratt, Kansas, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
Gastroenterology Associates
Baton Rouge, Louisiana, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Woodholme Gastroenterology Associates
Baltimore, Maryland, United States
Digestive Health Specialists PC
Chelmsford, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti, Michigan, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Atlantic Digestive Health Institute/ Atlantic IBD Center
Morristown, New Jersey, United States
A1 Clinical Research
Jackson Heights, New York, United States
Weill Cornell Medical College
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
Care Access Research
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 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
Cumberland Research Associates
Fayetteville, North Carolina, United States
Care Access Research, Kinston
Kinston, North Carolina, United States
Clinical Trials of America
Mount Airy, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Clinical Inquest Center, LTD
Beavercreek, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Synexus Clinical Research US Inc
Columbus, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Southwoods Health
Poland, Ohio, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, United States
Integris Baptist Office
Oklahoma City, Oklahoma, United States
US Digestive Health
Wyomissing, Pennsylvania, United States
Synexus Clinical Research US Inc
Anderson, South Carolina, United States
Gastroenterology Associates P.A.
Greenville, South Carolina, United States
Memorial Health Care System
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Tennessee State University
Johnson, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
DHAT Research Institute
Garland, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Houston Digestive Diseases Consultants
Houston, Texas, United States
CliniCore Houston
Houston, Texas, United States
Caprock Gastro Research
Lubbock, Texas, 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
Texas Digestive Disease Consultants
Southlake, Texas, United States
Texas Gastroenterology Associates - Research
Spring, Texas, United States
Baylor Scott and White Research Institute
Temple, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Center for Gastrointestinal Health
Petersburg, Virginia, United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, United States
Northwest Gastroenterology Associates - USA
Bellevue, Washington, United States
Washington Gastroenterology, PLLC
Tacoma, Washington, United States
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, , Australia
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, , Austria
Akh Wien
Vienna, , Austria
Grodno University Hospital
Grodno, , Belarus
Gomel Regional Clinical Hospital
Homyel, , Belarus
Republican Research Centre of Radiation Medicine and Human E
Homyel, , Belarus
Healthcare Institution,Minsk Scientific center for surgery,
Minsk, , Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, , Belarus
AZ Klina
Brasschaat, , Belgium
CHU Saint-Pierre
Brussels, , Belgium
Hopital Erasme
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Az Groeninge
Kortrijk, , Belgium
Algemeen Ziekenhuis Delta
Roeselare, , Belgium
CHwapi
Tournai, , Belgium
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, , Bosnia and Herzegovina
MK Blumenau Pesquisa Clínica
Blumenau, , Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, , Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília, , 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
Goiânia, , Brazil
Centro de Estudos Clínicos do Interior Paulista - CECIP
Jaú, , 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 André, , Brazil
Praxis pesquisa médica
Santo André, , Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
Santo André, , Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos São Paulo, , Brazil
Kaiser Hospta
São José do Rio Preto, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, , Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, , Brazil
Hemomed
São Paulo, , Brazil
BR Trials
São Paulo, , Brazil
Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
Teresina, , Brazil
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
Columbia Gastroenterology
New Westminster, British Columbia, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Barrie GI Associates
Barrie, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Mount Sinai Hospital-Toronto
Toronto, Ontario, Canada
Pharmaceutical Integrated Research Company
Waterloo, Ontario, Canada
MUHC Montreal General Hospital
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Peking University First Hospital
Beijing, , China
Beijing Friendship 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, , 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
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, , China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, , China
ZhuJiang Hospital of Southern Medical University
Guangzhou, , China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou, , China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
The First 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
Shanghai Ninth Peoples Hospital
Shanghai, , China
Huashan Hospital Fudan University
Shanghai, , China
Second Military Medical University (SMMU)
Shanghai, , China
Tongji Hospital of Tongji University
Shanghai, , China
Ruijin Hospital Shanghai Jiao Tong 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
Wuhan Union Hospital
Wuhan, , China
Renmin Hospital of Wuhan University
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, , China
Medplus Medicina Prepagada S.A.
Bogotá, , Colombia
Clinica de la Mujer
Bogotá, , Colombia
Endocare Ltda.
Bogotá, , Colombia
Centro Médico Imbanaco
Cali, , Colombia
Corporacion para Estudios en Salud Clinica CES - Gastroenterology
Medellín, , Colombia
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, , Croatia
Nemocnice Ceske Budejovice
České Budějovice, , Czechia
NH Hospital, a.s.
Hořovice, , Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Synexus Czech s.r.o.
Prague, , Czechia
ISCARE a.s.
Prague, , Czechia
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, , France
CHU de Nantes hotel Dieu
Nantes, , France
CHU de Nice Hopital de l Archet
Nice, , France
CHU Nimes Hopital Caremeau
Nîmes, , France
Hôpital Bichat
Paris, , France
Groupement Hospitalier Universitaire Ouest
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
Reims, , France
CHU Saint Etienne
Saint-Etienne, , France
Hopital D'Instruction Des Armees
Saint-Mandé, , France
CHRU de Strasbourg - Hopital de Hautepierre
Strasbourg, , France
CHU Toulouse - Hopital de Rangueil
Toulouse, , France
Hopital Rangueil
Toulouse, , France
CHU de Nancy_ Hopital Brabois
Vandœuvre-lès-Nancy, , France
LTD 'Aversi Clinic'
T'bilisi, , Georgia
TSMU The First University Clinic
Tbilisi, , Georgia
Institute of Clinical Cardiology, Ltd.
Tbilisi, , Georgia
LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital'
Tbilisi, , Georgia
LTD Helsicore
Tbilisi, , Georgia
LTD Unimed Kakheti- Telavi Referral Hospital
Telavi, , Georgia
Klinikum Augsburg
Augsburg, , Germany
Charite - Campus Mitte
Berlin, , Germany
Synexus Berlin Research Center
Berlin, , Germany
Universitaetsklinikum Charite, Campus Virchow Klinikum
Berlin, , Germany
Krankenhaus Waldfriede Mitte
Berlin, , Germany
Klinikum Dresden
Dresden, , Germany
Synexus Clinical Research GmbH
Frankfurt, , Germany
JWG-University Hospital
Frankfurt, , Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt am Main, , Germany
Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
Hamburg, , Germany
Asklepios Westklinikum
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
Karlshorst, , Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, , Germany
Eugastro GmbH
Leipzig, , Germany
Gastroenterologie und Hepatologie am Johannisplatz
Leipzig, , Germany
Staedtisches Klinikum Lueneburg
Lüneburg, , 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, , Germany
Laiko General Hospital of Athens
Athens, , Greece
University Hospital of Heraklion
Heraklion, , Greece
Réthy Pál Kórház - Rendelőintézet
Békéscsaba, , Hungary
Synexus Magyarorszag Kft
Budapest, , Hungary
Péterfy Sándor utcai Kórház
Budapest, , Hungary
Meddica Centre Hungarian Defence Froces
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Synexus Magyarorszag Kft
Gyula, , Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, , Hungary
Apex Hospitals Ltd
Jaipur, , India
Fortis Hospital
New Delhi, , India
Fortis Hospital
Noida, , India
Shree Giriraj Multispeciality Hospital
Rajkot, , India
Nirmal Hospital Pvt. Ltd.
Surat, , India
Surat Institute of Digestive Sciences Hospitals
Surat, , India
BAPS Pramukhswami Hospital
Surat, , India
Unity Hospital
Surat, , India
Ha'Emek Medical Center
Afula, , Israel
Barzilai Medical Center
Ashkelon, , Israel
Soroka Medical Center
Bear Sheva, , Israel
Rambam Medical Center
Haifa, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Hebrew University 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, , Israel
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
Milan, , Italy
Universita degli Studi di Padova - Azienda Ospedaliera di Padova
Padua, , Italy
Università Campus Biomedico di Roma
Roma, , Italy
Policlinico Universitario Agostino Gemelli
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, , Italy
Asahikawa City Hospital
Asahikawa, , Japan
Tokyo Medical and Dental University Hospital
Bunkyō City, , Japan
Juntendo University Hospital
Bunkyō City, , Japan
Juntendo University Hospital
Bunkyō City, , Japan
Chiba University Hospital
Chiba, , Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, , Japan
Saiseikai Fukuoka General Hospital
Fukuoka, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Gifu University Hospital
Gifu, , Japan
Tokai University Hachioji Hospital
Hachiōji, , Japan
Matsuda Hospital
Hamamatsu, , Japan
Mito Medical Center - Digestive Organs
Higashiibaraki-gun, , Japan
National Hospital Organization Hirosaki General Medical Center
Hirosaki, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
National Hospital Organization Kanazawa Medical Center
Ishikawa, , Japan
Izumiotsu Municipal Hospital
Izumiōtsu, , Japan
Shimane University Hospital
Izumo, , Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, , Japan
Sameshima Hospital
Kagoshima, , Japan
Nanpuh Hospital
Kagoshima, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Nara Medical University Hospital
Kashihara, , Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, , Japan
The Jikei University Hospital
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
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
JRC Kyoto Daiichi Hospital
Kyoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
Kitasato University Kitasato Institute Hospital
Minatoku, , 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 University Hospital
Nagoya, , Japan
Nagoya City University Hospital
Nagoya, , Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, , Japan
JA Obihiro Kosei Hospital
Obihiro, , Japan
Okayama Saiseikai General Hospital
Okayama, , Japan
Nakagami Hospital
Okinawa, , Japan
Kinshukai Infusion Clinic
Osaka, , Japan
Kitano Hospital
Osaka, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Japanese Red Cross Osaka Hospital
Osaka, , Japan
Osaka City University Hospital
Osaka, , Japan
Oita Red Cross Hospital
Ōita, , Japan
Kindai University Hospital
Ōsaka-sayama, , Japan
Osaki Citizen Hospital
Ōsaki, , Japan
Shiga University of Medical Science Hospital
Ōtsu, , Japan
National Hospital Organization Higashi Ohmi General Medical Center
Ōtsu, , Japan
Japan Community Health Care Organization Saitama Medical Center
Saitama, , Japan
Tokitokai Tokito Clinic Coloproctology Center
Saitama, , Japan
Saitama Medical University Hospital
Saitama, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
JA Sapporo-Kosei General Hospital - 1st Digestive Organs
Sapporo, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, , Japan
Sapporo IBD Clinic
Sapporo Chuo-ku, , Japan
Tokyo Yamate Medical Center
Shinjuku-ku, , Japan
Osaka University Hospital
Suita-shi, , Japan
Takamatsu Red Cross Hospital
Takamatsu, , Japan
Kagawa Prefectural Central Hospital
Takamatsu, , Japan
Tokushima University Hospital
Tokushima, , Japan
The Jikei University Hospital
Tokyo, , Japan
Yuaikai Tomishiro Central Hospital
Tomishiro, , Japan
Toyama City Hospital
Toyama, , Japan
Fujita Health University Hospital
Toyoake, , Japan
Ehime University Hospital
Tōon, , Japan
Mie University Hospital
Tsu, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Khalidi Hospital and Medical Center
Amman, , Jordan
Jordan University Hospital
Amman, , Jordan
Irbid Specialty Hospital
Irbid, , Jordan
King Abdullah University Hospital
Irbid, , Jordan
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Alda Pukisa arsta prakse
Riga, , Latvia
Ain Wazein Hospital
Ain Wazein, , Lebanon
American Universitty of Beirut Medical Center
Beirut, , Lebanon
St Georges Hospital university medical centre
Beirut, , Lebanon
Hotel Dieu de France Hospital
Beirut, , Lebanon
Bellevue Medical Center
Beirut, , Lebanon
Mount Lebanon Hospital
Beirut, , Lebanon
Rafik Hariri University Hospital
Beirut, , Lebanon
Nini Hospital
Tripoli, , Lebanon
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, , Lithuania
Hospital Ampang
Ampang, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Sultanah Aminah
Johor Bharu, , Malaysia
Hospital Raja Perempuan Zainab Ii
Kota Bharu, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Amsterdam UMC locatie VUMC
Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Stichting Zuyderland Medisch Centrum
Sittard-Geleen, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
General City Hospital 8mi Septemvri
Skopje, , North Macedonia
University Clinic of Gastroenterohepatology
Skopje, , North Macedonia
NZOZ Centrum Medyczne KERmed
Bydgoszcz, , Poland
Centrum Medyczne Lukamed
Chojnice, , Poland
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, , 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
Malopolskie Centrum Kliniczne
Krakow, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Centrum Medyczne Promed
Krakow, , Poland
Centrum Opieki Zdrowotnej Orkan Med Stec Michalska sj
Ksawerów, , Poland
Synexus Polska Sp z o o
Lodz, , Poland
AmiCare Centrum Medyczne
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
Oświęcim, , 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.
Rzeszów, , Poland
Endoskopia Sp z o.o.
Sopot, , Poland
Kiepury Clinic
Sosnowiec, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Szczecin, , Poland
GASTROMED Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
Torun, , Poland
H-T Centrum Medyczne Endoterapia
Tychy, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Centrum Medyczne
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, , Poland
Centrum Badawcze Wspolczesnej Terapii
Warsaw, , Poland
NZOZ Vivamed Zespol Lekarzy Specjalistow
Warsaw, , Poland
Szpital Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
Synexus Polska Sp z o o Oddzial w Warszawie
Warsaw, , Poland
Centrum Zdrowia Tuchow
Wierzchosławice, , Poland
Synexus Polska Sp z o o Oddzial we Wroclawiu
Wroclaw, , Poland
Przychodnia Vistamed
Wroclaw, , Poland
Futuremeds sp. z o.o.
Wroclaw, , Poland
Melita Medical Sp. z o.o.
Wroclaw, , Poland
ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c.
Wroclaw, , Poland
EuroMediCare Szpital Specjalistyczny z Przychodnia
Wroclaw, , Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Włocławek, , Poland
ETG Zamosc
Zamość, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , Portugal
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, , Portugal
Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
Portimão, , 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, , Portugal
San Juan Bautista School of Medicine
Caguas, , Puerto Rico
Kazan State Medical University
Kazan', , Russia
KGBUZ 'Regional Clinical Hospital'
Krasnoyarsk, , Russia
State Scientific Centre of Coloproctology
Moscow, , Russia
Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, , Russia
City Clinical Hospital #12
Novosibirsk, , Russia
FSBI 'Scientific Research Institute of Clinical and Experimental Lymphology' of Siberian Branch
Novosibirsk, , Russia
Clinical Diagnostic Center 'Ultramed'
Omsk, , Russia
GBUZ of Moscow Region City Clinical Hospital #3
Podolsk, , Russia
GBOU VPO Rostov State Medical University
Rostov-on-Don, , Russia
City Hospital #20
Rostov-on-Don, , Russia
Clinical Hospital #122 n.a. after L.G. Sokolov
Saint Petersburg, , Russia
City Hospital named after St. Martyr Elizabeth
Saint Petersburg, , Russia
The Limited Liability Company Research center Eco-safety
Saint Petersburg, , Russia
St.Petersburg State Medical University n.a.Pavlov
Saint Petersburg, , Russia
City Clinical Hospital #31
Saint Petersburg, , Russia
Medical University Reaviz
Samara, , Russia
NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
Samara, , Russia
Saratov City Hospital #5
Saratov, , Russia
Tomsk Regional Clinical Hospital
Tomsk, , Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, , Russia
GUZ Novgorod Regional Clinical Hospital
Veliky Novgorod, , Russia
King Abdullah Medical City in Holy Capital
Mecca, , Saudi Arabia
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, , Saudi Arabia
Special hospital for Internal diseases, Oncomed system
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
Zvezdara University Medical Center
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
General Hospital 'Djordje Joanovic'
Zrenjanin, , Serbia
FNsP F.D.R. Banska Bystrica
Banská Bystrica, , Slovakia
ENDOMED s.r.o
Košice, , Slovakia
GASTRO I. s.r.o.
Prešov, , Slovakia
Korea University Ansan Hospital
Ansan-si, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Kyongpook national university Medical center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam, , South Korea
The Catholic Univ of Korea DaeJeon St Mary's Hospital
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Yonsei University College of Medicine
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
Ewha Womans University Mokdong Hospital
Yangch’ŏn-gu, , South Korea
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
Seville, , Spain
Hosp. Univ. de Torrejon
Torrejón de Ardoz, , Spain
Hosp. Alvaro Cunqueiro
Vigo, , Spain
Hosp. Univ. Miguel Servet
Zaragoza, , Spain
Chang-Hua Christian Hospital
Changhua, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang-Gung Memorial Hospital-Linkou
Taoyuan District, , Taiwan
Hopital Regional Mohamed Tahar El Maamouri
Nabeul, , Tunisia
Hopital Universitaire Sahloul
Sousse, , Tunisia
Hopital Habib Thameur
Tunis, , Tunisia
Military Hospital of Instruction of Tunis
Tunis, , Tunisia
Hospital La Rabta
Tunis Jebbari, , Tunisia
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Firat University Hospital
Elâzığ, , Turkey (Türkiye)
Mustafa Kemal University Research and Practise Hospital
Hatay, , Turkey (Türkiye)
Acibadem Fulya Hospital
Istanbul, , Turkey (Türkiye)
Sisli Etfal Egitim ve Arastirma Hospital
Istanbul, , Turkey (Türkiye)
BAU Medical Park Goztepe Hospital
Istanbul, , Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, , Turkey (Türkiye)
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
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
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv, , Ukraine
Kyiv Regional Clinical Hospital
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
Uzhhorod, , Ukraine
Health Clinic Limited Liability Company
Vinnytsia, , Ukraine
KU 6 miska klinichna likarnia ZMR
Zaporizhzhya, , Ukraine
Barnsley District General Hospital
Barnsley, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
St Georges Healthcare NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Panaccione R, Feagan BG, Afzali A, Rubin DT, Reinisch W, Panes J, Danese S, Hisamatsu T, Terry NA, Salese L, Van Rampelbergh R, Sahoo A, Vetter ML, Yee J, Han C, Frustaci ME, Wan KYY, Yang Z, Johanns J, Andrews JM, D'Haens GR, Sands BE; GALAXI 2 & 3 Study Group. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025 Jul 26;406(10501):358-375. doi: 10.1016/S0140-6736(25)00681-6. Epub 2025 Jul 17.
Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
Danese S, Panaccione R, Feagan BG, Afzali A, Rubin DT, Sands BE, Reinisch W, Panes J, Sahoo A, Terry NA, Chan D, Han C, Frustaci ME, Yang Z, Sandborn WJ, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI-1 Study Group. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):133-146. doi: 10.1016/S2468-1253(23)00318-7. Epub 2023 Dec 14.
Sandborn WJ, D'Haens GR, Reinisch W, Panes J, Chan D, Gonzalez S, Weisel K, Germinaro M, Frustaci ME, Yang Z, Adedokun OJ, Han C, Panaccione R, Hisamatsu T, Danese S, Rubin DT, Sands BE, Afzali A, Andrews JM, Feagan BG; GALAXI-1 Investigators. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022 May;162(6):1650-1664.e8. doi: 10.1053/j.gastro.2022.01.047. Epub 2022 Feb 5.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNTO1959CRD3001
Identifier Type: OTHER
Identifier Source: secondary_id
2017-002195-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504736-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108387
Identifier Type: -
Identifier Source: org_study_id