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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
New Zealand4 sites
Auckland City Hospital
Auckland, 1142
Christchurch Hospital
Christchurch, 8140
Dunedin Hospital
Dunedin, 9016
Waikato Hospital
Hamilton, 3204
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
North Macedonia3 sites
General City Hospital 8mi Septemvri
Skopje, 1000
University Clinic of Gastroenterohepatology 1
Skopje, 1000
University Clinic of Gastroenterohepatology
Skopje, 1000
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
United Kingdom3 sites
Barnsley District General Hospital
Barnsley, S75 2EP
Addenbrooke's Hospital
Cambridge, CB2 0QQ
St Georges Healthcare NHS Trust
London, SW17 0QT
Austria2 sites
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, 5020
Akh Wien
Vienna, 1090
Greece2 sites
Laiko General Hospital of Athens
Athens, 11527
University Hospital of Heraklion
Heraklion, 71110
Latvia2 sites
Pauls Stradins Clinical University Hospital
Riga, LV-1002
Alda Pukisa arsta prakse
Riga, LV-1046
Lithuania2 sites
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas, LT-50161
Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, LT-08661
Saudi Arabia2 sites
King Abdullah Medical City in Holy Capital
Mecca, 21955
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, 11426
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 group | Role | What they receive |
|---|---|---|
| Phase 2 (GALAXI 1): Group 1 (Guselkumab) | Experimental | 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. Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2 |
| Phase 2 (GALAXI 1): Group 2 (Guselkumab) | Experimental | 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. Receives: Drug: Guselkumab Dose 2; Drug: Guselkumab Dose 3 |
| Phase 2 (GALAXI 1): Group 3 (Guselkumab) | Experimental | 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. Receives: Drug: Guselkumab Dose 4; Drug: Guselkumab Dose 5 |
| Phase 2 (GALAXI 1): Group 4 (Ustekinumab) | Active comparator | 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. Receives: Drug: Ustekinumab |
| Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) | Experimental | 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. Receives: Drug: Ustekinumab; Drug: Placebo |
| Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) | Experimental | 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. Receives: Drug: Guselkumab |
| Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab) | Active comparator | 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. Receives: Drug: Ustekinumab |
| Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab) | Experimental | 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. Receives: Drug: Ustekinumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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
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
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)
GALAXI 1: Percentage of Participants With Clinical Remission at Week 12
Measured: At Week 12
GALAXI 1: Percentage of Participants With Clinical Response at Week 12
Measured: At Week 12
GALAXI 1: Percentage of Participants With Patient-Reported Outcome (PRO) 2 Remission at Week 12
Measured: At Week 12
GALAXI 1: Percentage of Participants With Clinical-Biomarker Response at Week 12
Measured: At Week 12
GALAXI 1: Percentage of Participants With Endoscopic Response at Week 12
Measured: At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Response at Week 4
Measured: At Week 4
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 12
Measured: At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 12
Measured: At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
Measured: At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 12
Measured: At Week 12
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
Measured: At Week 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
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
Global: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
Measured: At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Measured: At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Both Clinical Remission and Endoscopic Response at Week 48
Measured: At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
Measured: At Week 48
Global: GALAXI 2 and 3: Percentage of Participants With Deep Remission at Week 48
Measured: At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 12
Measured: At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Fatigue Response at Week 12
Measured: At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 12
Measured: At Week 12
Regional: GALAXI 2 and 3: Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48
Measured: At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Response at Week 48
Measured: At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Endoscopic Remission at Week 48
Measured: At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Clinical Remission at Week 48
Measured: At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With Durable Clinical Remission at Week 48
Measured: At Week 48
Regional: GALAXI 2 and 3: Percentage of Participants With PRO-2 Remission at Week 48
Measured: At Week 48
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
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.
- First posted15 Mar 2018
- Study start13 Apr 2018
- Primary completion20 Oct 2023
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 42065683Panaccione 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 40684778Hasskamp 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 40357993Danese 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 38104569Sandborn 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