AzTrials
AzTrials

Crohn's DiseasePhase 2/3GALAXINCT03466411

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2/3 study testing Guselkumab Dose 1, Guselkumab Dose 2 and Guselkumab Dose 3 in people with Crohn's Disease, run by Janssen Research & Development, LLC at 579 sites in 43 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Guselkumab Dose 1, Guselkumab Dose 2 and Guselkumab Dose 3
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,409 participants
Where
579 sitesin 43 countries
Study dates
13 Apr 2018to 28 Jan 2028
Phase
Phase 2/3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

579 sites in 43 countries.

579 sites in 43 countries

United States109 sites
  • Advanced Research Center Inc

    Anaheim, California, 92805

  • Synexus Clinical Research US Inc

    Anderson, South Carolina, 29621-2062

  • Asheville Gastroenterology Associates

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30224

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Emory University

    Atlanta, Georgia, 30322

  • Woodholme Gastroenterology Associates

    Baltimore, Maryland, 21208

  • Gastroenterology Associates

    Baton Rouge, Louisiana, 70809

  • Clinical Inquest Center, LTD

    Beavercreek, Ohio, 45432

  • Northwest Gastroenterology Associates - USA

    Bellevue, Washington, 98004

  • Paul Wallace MD

    Beverly Hills, California, 90211

  • University North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Charlotte Gastroenterology and Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • Onsite Clinical Solutions

    Charlotte, North Carolina, 28277

  • Memorial Health Care System

    Chattanooga, Tennessee, 37404

  • Digestive Health Specialists PC

    Chelmsford, Massachusetts, 01824

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Pioneer Research Solutions Inc.

    Coconut Creek, Florida, 33066

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80920

  • Ohio State University

    Columbus, Ohio, 43210

  • Synexus Clinical Research US Inc 2

    Columbus, Ohio, 43212

  • Atlanta Center For Gastroenterology

    Decatur, Georgia, 30033

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • InvesClinic, LLC

    Fort Lauderdale, Florida, 33308

  • DHAT Research Institute

    Garland, Texas, 75044

  • Gastro One

    Germantown, Tennessee, 38138

  • Gastroenterology Associates P.A.

    Greenville, South Carolina, 29615

  • Harmony Medical Research Institute, Inc.

    Hialeah, Florida, 33016

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Houston Digestive Diseases Consultants

    Houston, Texas, 77074

  • CliniCore Houston

    Houston, Texas, 77079

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

  • Elite Research Network - Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • A1 Clinical Research

    Jackson Heights, New York, 11372

  • Tennessee State University

    Johnson, Tennessee, 37614-1700

  • Care Access Research, Kinston

    Kinston, North Carolina, 28501

  • SIH Research

    Kissimmee, Florida, 34759

  • University Of California San Diego

    La Jolla, California, 92093

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana, 70503

  • Auzmer Research

    Lakeland, Florida, 33813

  • Florida Research Center Inc.

    Lakewood Rch, Florida, 34211

  • Om Research LLC

    Lancaster, California, 93534

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • BVL Clinical Research

    Leawood, Kansas, 66211

  • Caprock Gastro Research

    Lubbock, Texas, 79424

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Homestead Associates in Research Inc

    Miami, Florida, 33032

  • Community Research Foundation, Inc.

    Miami, Florida, 33155

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157-6575

  • Visionary Investigators Network

    Miami, Florida, 33180

  • Allameh Medical Corp

    Mission Viejo, California, 92691

  • Internal Medicine Center

    Mobile, Alabama, 36693

  • Atlantic Digestive Health Institute/ Atlantic IBD Center

    Morristown, New Jersey, 07960

  • Clinical Trials of America

    Mount Airy, North Carolina, 27030

  • United Gastroenterologists

    Murrieta, California, 92563

  • Gastroenterology Group Of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212-1610

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Weill Cornell Medical College

    New York, New York, 10021

  • New York Gastroenterology Associates

    New York, New York, 10028

  • Care Access Research

    New York, New York, 10065

  • NYU Langone Medical Center

    New York, New York, 11021

  • Integris Baptist Office

    Oklahoma City, Oklahoma, 73112

  • Clinnova Research

    Orange, California, 92868

  • Florida Hospital

    Orlando, Florida, 32803

  • Omega Research Consultants

    Orlando, Florida, 32808

  • Care Access Research, Orlando

    Orlando, Florida, 32825

  • Center for Gastrointestinal Health

    Petersburg, Virginia, 23805

  • Synexus Clinical Research US Inc 1

    Pinellas Park, Florida, 33781

  • Southwoods Health

    Poland, Ohio, 44514

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Inland Empire Liver Foundation

    Rialto, California, 91106

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia, 24014-1372

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Gastroenterology Consultants

    Roswell, Georgia, 30076

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Central Florida Internists

    Saint Cloud, Florida, 34769

  • Gastroenterology Clinic Of San Antonio P A

    San Antonio, Texas, 78229

  • Gastroenterology Research of America, LLC

    San Antonio, Texas, 78229

  • UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Clinical Applications Laboratories, Inc

    San Diego, California, 91941

  • LSUHSC Shreveport Feist-Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Texas Gastroenterology Associates - Research

    Spring, Texas, 77386

  • Synergy Clinical Research

    St. Petersburg, Florida, 33705

  • Theia Clincial Research, LLC

    St. Petersburg, Florida, 33709

  • Atlanta Gastroenterology Specialists PC

    Suwanee, Georgia, 30024

  • Syracuse VA Medical Center

    Syracuse, New York, 13210

  • Washington Gastroenterology, PLLC

    Tacoma, Washington, 98405

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Florida Hospital Tampa

    Tampa, Florida, 33613

  • Alliance Clinical Research

    Tampa, Florida, 33615

  • Baylor Scott and White Research Institute

    Temple, Texas, 76508

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

  • University of Arizona

    Tucson, Arizona, 85724

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • US Digestive Health

    Wyomissing, Pennsylvania, 19610

  • Huron Gastroenterology Associates Center for Digestive Care

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan77 sites
  • Asahikawa City Hospital

    Asahikawa, 087-8686

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113 8519

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • Juntendo University Hospital 1

    Bunkyō City, 279-0021

  • Chiba University Hospital

    Chiba, 260-8677

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Saiseikai Fukuoka General Hospital

    Fukuoka, 810-0001

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Gifu University Hospital

    Gifu, 501-1194

  • Tokai University Hachioji Hospital

    Hachiōji, 192-0032

  • Matsuda Hospital

    Hamamatsu, 432-8061

  • Mito Medical Center - Digestive Organs

    Higashiibaraki-gun, 311-3193

  • National Hospital Organization Hirosaki General Medical Center

    Hirosaki, 036-8174

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Hospital Organization Kanazawa Medical Center

    Ishikawa, 920 8650

  • Izumiotsu Municipal Hospital

    Izumiōtsu, 595-0027

  • Shimane University Hospital

    Izumo, 693-8501

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

  • Sameshima Hospital

    Kagoshima, 892-0846

  • Nanpuh Hospital

    Kagoshima, 892-8512

  • Kanazawa University Hospital

    Kanazawa, 9208651

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

  • The Jikei University Hospital 1

    Kashiwa, 277-8567

  • Aoyama Naika Clinic

    Kobe, 650-0015

  • Kobe University Hospital

    Kobe, 650-0017

  • National Hospital Organization Kochi National Hospital

    Kochi, 780-8077

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure, 736-0023

  • Kurume University Hospital

    Kurume, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • JRC Kyoto Daiichi Hospital

    Kyoto, 605-0981

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Iwate Medical University Hospital

    Morioka, 020-8505

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Nagaoka Red Cross Hospital

    Nagaoka, 940-2085

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, 663-8501

  • JA Obihiro Kosei Hospital

    Obihiro, 080-0024

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Okayama Saiseikai General Hospital

    Okayama, 700-8511

  • Nakagami Hospital

    Okinawa, 904-2195

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • Kitano Hospital

    Osaka, 530-8480

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Japanese Red Cross Osaka Hospital

    Osaka, 543 8555

  • Osaka City University Hospital

    Osaka, 545-8586

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

  • Osaki Citizen Hospital

    Ōsaki, 989-6183

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • National Hospital Organization Higashi Ohmi General Medical Center

    Ōtsu, 527-8505

  • Japan Community Health Care Organization Saitama Medical Center

    Saitama, 330-0074

  • Tokitokai Tokito Clinic Coloproctology Center

    Saitama, 336-0963

  • Saitama Medical University Hospital

    Saitama, 350-0495

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • JA Sapporo-Kosei General Hospital - 1st Digestive Organs

    Sapporo, 060-0033

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Sapporo IBD Clinic

    Sapporo Chuo-ku, 064-0919

  • Tokyo Yamate Medical Center

    Shinjuku-ku, 169-0073

  • Osaka University Hospital

    Suita-shi, 565-0871

  • Takamatsu Red Cross Hospital

    Takamatsu, 760-0017

  • Kagawa Prefectural Central Hospital

    Takamatsu, 760-85557

  • Tokushima University Hospital

    Tokushima, 770-8503

  • The Jikei University Hospital

    Tokyo, 105 8471

  • Yuaikai Tomishiro Central Hospital

    Tomishiro, 901-0243

  • Ehime University Hospital

    Tōon, 791-0295

  • Toyama City Hospital

    Toyama, 939 8511

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • Mie University Hospital

    Tsu, 514-8507

  • Wakayama Medical University Hospital

    Wakayama, 641-8509

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Poland45 sites
  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85 681

  • Centrum Medyczne Lukamed

    Chojnice, 89-600

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Częstochowa, 42-202

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80 382

  • Synexus Scm Sp Z o o Oddzial Gdynia

    Gdynia, 81 537

  • Prywatna Praktyka Lekarska

    Jelenia Góra, 8 500

  • Synexus Polska Sp z o o Oddzial w Katowicach

    Katowice, 40 040

  • Malopolskie Centrum Kliniczne

    Krakow, 30 149

  • Centrum Medyczne Plejady

    Krakow, 30 363

  • Centrum Medyczne Promed

    Krakow, 31-411

  • Centrum Opieki Zdrowotnej Orkan Med Stec Michalska sj

    Ksawerów, 95-054

  • Synexus Polska Sp z o o

    Lodz, 90 127

  • AmiCare Centrum Medyczne

    Lodz, 90-644

  • 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ W Lublinie

    Lublin, 20 049

  • Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

    Lublin, 20-582

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10 561

  • Twoja Przychodnia 1

    Opole, 45-819

  • Oswiecimskie Centrum Badan Klinicznych

    Oświęcim, 32 600

  • EMC Instytut Medyczny SA

    Poznan, 60 309

  • Solumed S C

    Poznan, 60 529

  • Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

    Poznan, 60-702

  • Twoja Przychodnia

    Poznan, 61-293

  • Centrum Medyczne 'Medyk' Sp. z o.o. K.

    Rzeszów, 35-055

  • Endoskopia Sp z o.o.

    Sopot, 81-756

  • Kiepury Clinic

    Sosnowiec, 41-209

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Niepubliczny Zaklad Opieki Zdrowotnej

    Szczecin, 71-685

  • GASTROMED Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie

    Torun, 87 100

  • H-T Centrum Medyczne Endoterapia

    Tychy, 43-100

  • Wojskowy Instytut Medyczny

    Warsaw, 00 141

  • Centrum Medyczne

    Warsaw, 02 676

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Centrum Badawcze Wspolczesnej Terapii

    Warsaw, 02-679

  • NZOZ Vivamed Zespol Lekarzy Specjalistow

    Warsaw, 03-580

  • Szpital Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730

  • Synexus Polska Sp z o o Oddzial w Warszawie

    Warsaw, 623832

  • Centrum Zdrowia Tuchow

    Wierzchosławice, 33-122

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

    Włocławek, 87-800

  • Synexus Polska Sp z o o Oddzial we Wroclawiu

    Wroclaw, 50 381

  • Przychodnia Vistamed

    Wroclaw, 50 449

  • Futuremeds sp. z o.o.

    Wroclaw, 50-088

  • Melita Medical Sp. z o.o.

    Wroclaw, 50-449

  • ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c.

    Wroclaw, 53-333

  • EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, 54 144

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

China35 sites
  • Peking University First Hospital

    Beijing, 100034

  • Beijing Friendship Hospital

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • The Military General Hospital of Beijing PLA

    Beijing, 100700

  • The second Xiangya Hospital of Central South University

    Changsha, 200120

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004

  • West China Hospital Sichuan University

    Chengdu, 610041

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, 341000

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, 510080

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, 510235

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, 510280

  • Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

    Guangzhou, 510610

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Huai'an 1st Hospital

    Huai'an

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • Shanghai Ninth Peoples Hospital

    Shanghai, 200011

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • Second Military Medical University (SMMU)

    Shanghai, 200433

  • Tongji Hospital of Tongji University

    Shanghai, 430030

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • The first affiliated hospital of suzhou University

    Suzhou

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325003

  • Wuhan Union Hospital

    Wuhan, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Wuxi People s Hospital

    Wuxi, 214023

  • Zhongshan Hospital, Xiamen University

    Xiamen, 361004

  • Yangzhou First People's Hospital

    Yangzhou, 225001

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, 363000

Other trials in China

Brazil24 sites
  • MK Blumenau Pesquisa Clínica

    Blumenau, 89010-506

  • Universidade Estadual Paulista 'Julio De Mesquita Filho'

    Botucatu, 18618-970

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200 730

  • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

    Campinas, 13060-904

  • Hospital Nossa Senhora Das Gracas

    Curitiba, 80810-040

  • Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro

    Goiânia, 74535-170

  • Centro de Estudos Clínicos do Interior Paulista - CECIP

    Jaú, 17201-130

  • CMIP - Centro Mineiro de Pesquisa Ltda

    Juiz de Fora, 36010 570

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Instituto do Aparelho Digestivo

    Porto Alegre, 90560-002

  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina

    Rio de Janeiro, 21941-913

  • Hospital Santa Izabel

    Salvador, 40050-410

  • Pesquisare Saude

    Santo André, 09080-110

  • Praxis pesquisa médica

    Santo André, 09090-790

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    Santo André, 09190-510

  • Irmandade da Santa Casa da Misericórdia de Santos

    Santos São Paulo, 11075-101

  • Kaiser Hospta

    São José do Rio Preto, 15015-110

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090-000

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, 01228-200

  • Hemomed

    São Paulo, 01236-030

  • BR Trials

    São Paulo, 03325-050

  • Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

    Teresina, 64049-550

Other trials in Brazil

France23 sites
  • CHU Amiens

    Amiens, 80054

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

  • CHRU Besancon Hopital Jean Minjoz

    Besançon, 25000

  • Centre Hospitalier Universitaire (CHU) de Caen

    Caen, 14033

  • CHRU de Tours - Hopital Trousseau

    Chambray Les Tours Centre, 37170

  • Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

    Créteil, 94010

  • CHU Grenoble

    Grenoble, 38700

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037

  • Hopital Nord Marseille

    Marseille, 13915

  • CHRU Montpellier - Hopital Saint-Eloi

    Montpellier, 34295

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • CHU de Nice Hopital de l Archet

    Nice, 06202

  • CHU Nimes Hopital Caremeau

    Nîmes, 30029

  • Hôpital Bichat

    Paris, 75877

  • Groupement Hospitalier Universitaire Ouest

    Paris, 75908

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

    Reims, 51092

  • CHU Saint Etienne

    Saint-Etienne, 42270

  • Hopital D'Instruction Des Armees

    Saint-Mandé, 94160

  • CHRU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67098

  • CHU Toulouse - Hopital de Rangueil

    Toulouse, 31059

  • Hopital Rangueil

    Toulouse, 50032

  • CHU de Nancy_ Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany23 sites
  • Klinikum Augsburg

    Augsburg, D-86158

  • Charite - Campus Mitte

    Berlin, 10117

  • Synexus Berlin Research Center

    Berlin, 12627

  • Universitaetsklinikum Charite, Campus Virchow Klinikum

    Berlin, 13353

  • Krankenhaus Waldfriede Mitte

    Berlin, 14163

  • Klinikum Dresden

    Dresden, 1307

  • Synexus Clinical Research GmbH

    Frankfurt, 60313

  • JWG-University Hospital

    Frankfurt, 69590

  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

    Frankfurt am Main, 60431

  • Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

    Hamburg, 20246

  • Asklepios Westklinikum

    Hamburg, 22559

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Gastroenterologische Spezialpraxis - Berlin-Karlshorst

    Karlshorst, 10318

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

  • Eugastro GmbH

    Leipzig, 04103

  • Gastroenterologie und Hepatologie am Johannisplatz

    Leipzig, 04103

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

  • Gemeinschaftspraxis Germania-Campus

    Münster, 48159

  • Praxiszentrum Alte Mälzerei

    Regensburg, 93053

  • Zentrum für Gastroenterologie Saar MVZ GmbH

    Saarbrücken, 66111

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Russia21 sites
  • Kazan State Medical University

    Kazan', 420012

  • KGBUZ 'Regional Clinical Hospital'

    Krasnoyarsk, 660022

  • State Scientific Centre of Coloproctology

    Moscow, 123423

  • Novgorod Regional Clinical Hospital n.a. N.A. Semashko

    Nizhny Novgorod, 603126

  • City Clinical Hospital #12

    Novosibirsk, 630091

  • FSBI 'Scientific Research Institute of Clinical and Experimental Lymphology' of Siberian Branch

    Novosibirsk, 630117

  • Clinical Diagnostic Center 'Ultramed'

    Omsk, 644024

  • GBUZ of Moscow Region City Clinical Hospital #3

    Podolsk, 142105

  • GBOU VPO Rostov State Medical University

    Rostov-on-Don, 344022

  • City Hospital #20

    Rostov-on-Don, 344091

  • Clinical Hospital #122 n.a. after L.G. Sokolov

    Saint Petersburg, 194291

  • City Hospital named after St. Martyr Elizabeth

    Saint Petersburg, 195257

  • The Limited Liability Company Research center Eco-safety

    Saint Petersburg, 196143

  • St.Petersburg State Medical University n.a.Pavlov

    Saint Petersburg, 197022

  • City Clinical Hospital #31

    Saint Petersburg, 197110

  • Medical University Reaviz

    Samara, 443001

  • NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'

    Samara, 443041

  • Saratov City Hospital #5

    Saratov, 410071

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

  • GUZ Novgorod Regional Clinical Hospital

    Velikiy Novgorod, 173008

Other trials in Russia

South Korea18 sites
  • Korea University Ansan Hospital

    Ansan-si, 15355

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Dong-A University Hospital

    Busan, 49201

  • Kyongpook national university Medical center

    Daegu, 41404

  • Kyungpook National University Hospital

    Daegu, 41944

  • The Catholic university of Korea, St. Vincent's Hospital

    Gyeonggi-do, 16247

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, 18450

  • CHA Bundang Medical Center, CHA University

    Seongnam, 13496

  • The Catholic Univ of Korea DaeJeon St Mary s Hospital

    Seongnam, 13620

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Yonsei University College of Medicine

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Chung-Ang University Hospital

    Seoul, 06973

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Wonju Christian Hospital

    Wŏnju, 26426

  • Ewha Womans University Mokdong Hospital

    Yangch’ŏn-gu, 07985

Other trials in South Korea

Italy14 sites
  • Policlinico S.Orsola Malpighi, AOU di Bologna

    Bologna, 40138

  • Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

    Cagliari, 09042

  • Ospedale Santissima Annunziata

    Cento, 44042

  • AOU Policlinico G.Martino

    Messina, 98125

  • Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura

    Milan, 20097

  • Universita degli Studi di Padova - Azienda Ospedaliera di Padova

    Padova, 35128

  • Università Campus Biomedico di Roma

    Roma, 00128

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Complesso Integrato Columbus

    Rome, 00168

  • IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

    Rozzano, 20089

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • S.C. Gastroenterologia

    Torino, 10128

  • Azienda Ospedaliero Universitaria S.Maria Della Misericordia

    Udine, 33100

  • Policlinico G.B.Rossi

    Verona, 37134

Other trials in Italy

Ukraine13 sites
  • MNCE City Clinical Hospital No 2 named after prof O O Shalimov of the Kharkiv City Council

    Kharkiv, 61037

  • SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'

    Kharkiv, 61039

  • KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha

    Kherson, 73000

  • KNP Kyivska miska klinichna likarnia №18 vykonavchoho orhanu KMR (KMDA)

    Kyiv, 01030

  • LLC Treatment and Diagnostic Center Adonis Plus

    Kyiv, 02002

  • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

    Kyiv, 03037

  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

    Kyiv, 03049

  • Kyiv Regional Clinical Hospital

    Kyiv, 4107

  • Odeska oblasna klinichna likarnia

    Odesa, 65025

  • Ternopil municipal hospital #1

    Ternopil, 46000

  • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

    Uzhhorod, 88018

  • Health Clinic Limited Liability Company

    Vinnytsia, 21009

  • KU 6 miska klinichna likarnia ZMR

    Zaporizhzhya, 69035

Other trials in Ukraine

Israel12 sites
  • Ha'Emek Medical Center

    Afula, 1834111

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka Medical Center

    Bear Sheva, 84100

  • Rambam Medical Center

    Haifa, 31096

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Hebrew University Medical Center

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Med Ctr Beilinson Hosp

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Harofeh Medical Center

    Tzrifin, 70300

Other trials in Israel

Spain12 sites
  • Hosp Reina Sofia

    Córdoba, 14004

  • Complejo Hosp Univ. de Ferrol

    Ferrol, 15405

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007

  • Hosp. Gral. Juan Ramon Jimenez

    Huelva, 21005

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Central de Asturias

    Oviedo, 33011

  • Hosp. Provincial de Pontevedra

    Pontevedra, 36071

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Univ. de Torrejon

    Torrejón de Ardoz, 28850

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Australia11 sites
  • The Queen Elizabeth Hospital

    Adelaide, 5011

  • Monash Health, Monash Medical Centre

    Clayton, 3168

  • Concord Hospital

    Concord, 2139

  • Austin Hospital

    Heidelberg, 3084

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Royal Adelaide Hospital

    North Terrace, 5000

  • Royal Melbourne Hospital

    Parkville, 3050

  • Nepean Hospital

    Penrith, 2751

  • The Alfred Hospital

    Prahran, 3004

  • Mater Hospital Brisbane

    South Brisbane, 4101

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Canada11 sites
  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • University of Calgary

    Calgary, Alberta, T2N4Z6

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

  • University of Alberta- Ziedler Ledcor Centre

    Edmonton, Alberta, T6G 2X8

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • MUHC Montreal General Hospital

    Montreal, Quebec, H3H2R9

  • Columbia Gastroenterology

    New Westminster, British Columbia

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Mount Sinai Hospital-Toronto

    Toronto, Ontario, M5G 1X5

  • Pharmaceutical Integrated Research Company

    Waterloo, Ontario, N2J 1C4

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A1R9

Other trials in Canada

Turkey (Türkiye)9 sites
  • Hacettepe University Medical Faculty

    Ankara, 06230

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 6010

  • Firat University Hospital

    Elâzığ, 23200

  • Mustafa Kemal University Research and Practise Hospital

    Hatay, 31001

  • Acibadem Fulya Hospital

    Istanbul, 34349

  • Sisli Etfal Egitim ve Arastirma Hospital

    Istanbul, 34360

  • BAU Medical Park Goztepe Hospital

    Istanbul, 34732

  • Marmara University Medical Faculty

    Istanbul, 34899

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340

Other trials in Turkey (Türkiye)

India8 sites
  • Apex Hospitals Ltd

    Jaipur, 302017

  • Fortis Hospital 1

    New Delhi, 110088

  • Fortis Hospital

    Noida, 201301

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360005

  • Nirmal Hospital Pvt. Ltd.

    Surat, 395002

  • Surat Institute of Digestive Sciences Hospitals

    Surat, 395002

  • BAPS Pramukhswami Hospital

    Surat, 395009

  • Unity Hospital

    Surat, 395010

Other trials in India

Lebanon8 sites
  • Ain Wazein Hospital

    Ain Wazein

  • American Universitty of Beirut Medical Center

    Beirut, 110 72020

  • St Georges Hospital university medical centre

    Beirut, 166378

  • Hotel Dieu de France Hospital

    Beirut, 166830

  • Bellevue Medical Center

    Beirut

  • Mount Lebanon Hospital

    Beirut

  • Rafik Hariri University Hospital

    Beirut

  • Nini Hospital

    Tripoli, NAP

Other trials in Lebanon

Belgium7 sites
  • AZ Klina

    Brasschaat, 2930

  • CHU Saint-Pierre

    Brussels, 1000

  • Hopital Erasme

    Brussels, 1070

  • UZ Gent

    Ghent, 9000

  • Az Groeninge

    Kortrijk, 8500

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

  • CHwapi

    Tournai, 7500

Other trials in Belgium

Hungary7 sites
  • Réthy Pál Kórház - Rendelőintézet

    Békéscsaba, 5600

  • Synexus Magyarorszag Kft

    Budapest, 1036

  • Péterfy Sándor utcai Kórház

    Budapest, 1076

  • Meddica Centre Hungarian Defence Froces

    Budapest, H-1062

  • Semmelweis Egyetem

    Budapest, H-1088

  • Synexus Magyarorszag Kft

    Gyula, 5700

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Croatia6 sites
  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • Opca bolnica Zadar

    Zadar, 23000

  • CH Sestre Milosrdnice

    Zagreb, 10000

  • Poliklinika Solmed

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

  • University Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Czechia6 sites
  • Nemocnice Ceske Budejovice

    České Budějovice, 370 01

  • NH Hospital, a.s.

    Hořovice, 268 31

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Synexus Czech s.r.o.

    Prague, 120 00

  • ISCARE a.s.

    Prague, 190 00

Other trials in Czechia

Georgia6 sites
  • TSMU The First University Clinic

    Tbilisi, 0141

  • Institute of Clinical Cardiology, Ltd.

    Tbilisi, 0159

  • LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital'

    Tbilisi, 0159

  • LTD 'Aversi Clinic'

    Tbilisi, 0160

  • LTD Helsicore

    Tbilisi, 112

  • LTD Unimed Kakheti- Telavi Referral Hospital

    Telavi, 2200

Other trials in Georgia

Malaysia6 sites
  • Hospital Ampang

    Ampang, 68000

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990

  • Hospital Sultanah Aminah

    Johor Bharu, 80100

  • Hospital Raja Perempuan Zainab Ii

    Kota Bharu, 15160

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

Other trials in Malaysia

Portugal6 sites
  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

  • Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

    Guimarães, 4835-044

  • Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

    Portimão, 8500-338

  • H. Santo António - Centro Hospitalar do Porto

    Porto, 4099-001

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Serbia6 sites
  • Special hospital for Internal diseases, Oncomed system

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Zvezdara University Medical Center

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • General Hospital 'Djordje Joanovic'

    Zrenjanin, 23000

Other trials in Serbia

Belarus5 sites
  • Grodno University Hospital

    Grodno, 230017

  • Gomel Regional Clinical Hospital

    Homyel, 246029

  • Republican Research Centre of Radiation Medicine and Human E

    Homyel, 246040

  • Healthcare Institution,Minsk Scientific center for surgery,

    Minsk, 220116

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

Bosnia and Herzegovina5 sites
  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

  • Clinical hospital Mostar

    Mostar, 88000

  • Clinical Center University of Sarajevo

    Sarajevo, 71000

  • Polyclinic Dr. Al-Tawil

    Sarajevo, 71000

  • Cantonal Hospital Zenica

    Zenica, 72000

Other trials in Bosnia and Herzegovina

Colombia5 sites
  • Medplus Medicina Prepagada S.A.

    Bogotá, 110111

  • Clinica de la Mujer

    Bogotá, 110221

  • Endocare Ltda.

    Bogotá, 111111

  • Centro Médico Imbanaco

    Cali, 760042

  • Corporacion para Estudios en Salud Clinica CES - Gastroenterology

    Medellín, 50012

Other trials in Colombia

Tunisia5 sites
  • Hopital Regional Mohamed Tahar El Maamouri

    Nabeul, 8000

  • Hopital Universitaire Sahloul

    Sousse, 4051

  • Hopital Habib Thameur

    Tunis, 1008

  • Military Hospital of Instruction of Tunis

    Tunis

  • Hospital La Rabta

    Tunis Jebbari, 1007

Other trials in Tunisia

Jordan4 sites
  • Khalidi Hospital and Medical Center

    Amman, 11183

  • Jordan University Hospital

    Amman, 11942

  • Irbid Specialty Hospital

    Irbid, 21110

  • King Abdullah University Hospital

    Irbid, 22110

Other trials in Jordan

Netherlands4 sites
  • Amsterdam UMC locatie VUMC

    Amsterdam, 7057-1007 MB

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

  • Stichting Zuyderland Medisch Centrum

    Sittard-Geleen, 6130 MB

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

New Zealand4 sites
  • Auckland City Hospital

    Auckland, 1142

  • Christchurch Hospital

    Christchurch, 8140

  • Dunedin Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3204

Other trials in New Zealand

Taiwan4 sites
  • Chang-Hua Christian Hospital

    Changhua, 500

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang-Gung Memorial Hospital-Linkou

    Taoyuan, 33305

Other trials in Taiwan

North Macedonia3 sites
  • General City Hospital 8mi Septemvri

    Skopje, 1000

  • University Clinic of Gastroenterohepatology 1

    Skopje, 1000

  • University Clinic of Gastroenterohepatology

    Skopje, 1000

Other trials in North Macedonia

Slovakia3 sites
  • FNsP F.D.R. Banska Bystrica

    Banská Bystrica, 975 17

  • ENDOMED s.r.o

    Košice, 040 13

  • GASTRO I. s.r.o.

    Prešov, 080 01

Other trials in Slovakia

United Kingdom3 sites
  • Barnsley District General Hospital

    Barnsley, S75 2EP

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • St Georges Healthcare NHS Trust

    London, SW17 0QT

Other trials in United Kingdom

Austria2 sites
  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020

  • Akh Wien

    Vienna, 1090

Other trials in Austria

Greece2 sites
  • Laiko General Hospital of Athens

    Athens, 11527

  • University Hospital of Heraklion

    Heraklion, 71110

Other trials in Greece

Latvia2 sites
  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • Alda Pukisa arsta prakse

    Riga, LV-1046

Other trials in Latvia

Lithuania2 sites
  • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

    Kaunas, LT-50161

  • Vilnius University Hospital Santaros Klinikos, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

Saudi Arabia2 sites
  • King Abdullah Medical City in Holy Capital

    Mecca, 21955

  • King Abdul Aziz Medical City for National Guard Health Affairs

    Riyadh, 11426

Other trials in Saudi Arabia

Puerto Rico1 site
  • San Juan Bautista School of Medicine

    Caguas, 00726

Other trials in Puerto Rico

About this study

Official title: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

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.

Read the detailed 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.

Conditions
Crohn's Disease
Being tested
Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Guselkumab Dose 4, Guselkumab Dose 5
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guselkumab Dose 1Drug

    Guselkumab will be administered by IV infusion.

  • Guselkumab Dose 2Drug

    Guselkumab will be administered by SC injection.

  • Guselkumab Dose 3Drug

    Guselkumab will be administered by IV infusion.

  • Guselkumab Dose 4Drug

    Guselkumab will be administered by IV infusion.

  • Guselkumab Dose 5Drug

    Guselkumab will be by SC injection.

  • GuselkumabDrug

    Guselkumab will be administered by IV infusion and SC injection.

  • UstekinumabDrug

    Ustekinumab will be administered by IV infusion and SC injection.

  • PlaceboDrug

    Placebo will be administered as IV infusion.

Study groups in NCT03466411
Study groupRoleWhat they receive
Phase 2 (GALAXI 1): Group 1 (Guselkumab)ExperimentalParticipants 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.
Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2
Phase 2 (GALAXI 1): Group 2 (Guselkumab)ExperimentalParticipants 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.
Receives: Drug: Guselkumab Dose 2; Drug: Guselkumab Dose 3
Phase 2 (GALAXI 1): Group 3 (Guselkumab)ExperimentalParticipants 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.
Receives: Drug: Guselkumab Dose 4; Drug: Guselkumab Dose 5
Phase 2 (GALAXI 1): Group 4 (Ustekinumab)Active comparatorParticipants 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.
Receives: Drug: Ustekinumab
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)ExperimentalParticipants 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.
Receives: Drug: Ustekinumab; Drug: Placebo
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)ExperimentalParticipants 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.
Receives: Drug: Guselkumab
Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)Active comparatorParticipants 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.
Receives: Drug: Ustekinumab
Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)ExperimentalParticipants 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.
Receives: Drug: Ustekinumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12

    The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity. Baseline was defined as the last observation prior to or at the date of the first study intervention.

    Measured: Baseline and Week 12

  2. Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

    Clinical response was defined as a decrease from baseline (BL) in CDAI score greater than or equal to (>=) 100 points or CDAI score <150. Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Measured: Weeks 48

  3. Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

    CR: decrease from BL in CDAI score >=100/<150. ER: >=50% improvement from BL in SES-CD score/SES-CD score <=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

    Measured: Weeks 48

  4. Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48

    Clinical response was defined as a decrease from baseline in CDAI score >= 100 points or CDAI score <150. Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Measured: Weeks 48

  5. Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48

    CR: decrease from BL in CDAI score >=100/<150. ER: >=50% improvement from BL in SES-CD score/SES-CD score <=2. CDAI(8 variables):extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid/soft stools, abdominal pain/cramps, general well-being. Last 3 variables scored over 7 eligible days by participant on diary. Total CDAI score ranged:0-600(in general):higher score=higher disease activities. Decrease in total CDAI score over time=improvement in disease. SES-CD evaluated 4 endoscopic components (presence \& size of ulcer, extent of ulcerated surface, extent of affected surface, presence \& type of narrowing) across 5 ileocolonic segments (ileum; right, left \& transverse colon; rectum) each scored 0(best) to 3(worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. SES-CD score: sum of all component scores(all segments) ranged:0-56, higher scores=more severe disease.

    Measured: Weeks 48

  6. Regional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12

    Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Measured: Week 12

  7. Regional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12

    Endoscopic response was defined as >=50% improvement from baseline in SES-CD score or SES-CD score <=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

    Measured: Week 12

  8. Regional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12

    Clinical remission was defined as a CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 eligible days by the participant on a diary card. The total CDAI score ranged from 0 to 600 in general: higher score indicated higher disease activities. A decrease in total CDAI score over time indicates improvement in disease activity.

    Measured: Week 12

  9. Regional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12

    Endoscopic response was defined as >=50% improvement from baseline in SES-CD score or SES-CD score <=2. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, rectum), each scored 0 (best) to 3 (worst) except narrowing component for which maximum total score (that is, stricturing) was 11 points. Total SES-CD score: sum of all component scores across all segments, ranged: 0 to 56, higher scores = more severe disease.

    Measured: Week 12

Secondary outcomes (29)
  1. GALAXI 1: Percentage of Participants With Clinical Remission at Week 12

    Measured: At Week 12

  2. GALAXI 1: Percentage of Participants With Clinical Response at Week 12

    Measured: At Week 12

  3. GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12

    Measured: At Week 12

  4. GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12

    Measured: At Week 12

  5. GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12

    Measured: At Week 12

  6. Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4

    Measured: At Week 4

  7. Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12

    Measured: At Week 12

  8. Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12

    Measured: At Week 12

  9. Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12

    Measured: At Week 12

  10. Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12

    Measured: At Week 12

  11. Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12

    Measured: At Week 12

  12. Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Corticosteroid-Free Clinical Remission at Week 48

    Measured: At Week 48

  13. Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Response at Week 12 and Endoscopic Remission at Week 48

    Measured: At Week 48

  14. Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48

    Measured: At Week 48

  15. Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48

    Measured: At Week 48

  16. Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48

    Measured: At Week 48

  17. Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48

    Measured: At Week 48

  18. Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48

    Measured: At Week 48

  19. Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12

    Measured: At Week 12

  20. Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12

    Measured: At Week 12

  21. Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12

    Measured: At Week 12

  22. Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48

    Measured: At Week 48

  23. Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48

    Measured: At Week 48

  24. Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48

    Measured: At Week 48

  25. Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48

    Measured: At Week 48

  26. Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48

    Measured: At Week 48

  27. Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48

    Measured: At Week 48

  28. Regional: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission at Week 48 and Endoscopic Response at Week 48

    Measured: At Week 48

  29. Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Remission at Week 48

    Measured: At Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2018
  2. Study start13 Apr 2018
  3. Primary completion20 Oct 2023
  4. Study completion28 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03466411
Sponsor's protocol ID
CR108387
Other IDs
CNTO1959CRD3001, 2017-002195-13, 2023-504736-18-00, 2023, 2017
Acronym
GALAXI
Status last verified
Sep 2026
First submitted
8 Mar 2018
Last updated
28 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Afzali A, Danese S, Panaccione R, Rubin DT, Sands BE, Reinisch W, Panes J, Van Rampelbergh R, Terry NA, Salese L, Vetter ML, Yee J, Corbett C, van Duijnhoven W, Hisamatsu T, Andrews JM, D'Haens GR; GALAXI 1 investigators. Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial. Inflamm Bowel Dis. 2026 May 1:izag055. doi: 10.1093/ibd/izag055. Online ahead of print.

    PubMed 42065683
  • 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.

    PubMed 40684778
  • 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.

    PubMed 40357993
  • 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.

    PubMed 38104569
  • 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.

    PubMed 35134323

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