Crohn DiseasePhase 3GRAVITINCT05197049
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Guselkumab Dose 1, Guselkumab Dose 2 and Guselkumab Dose 3 in people with Crohn Disease, run by Janssen Research & Development, LLC at 345 sites in 27 countries.
Trial summary
The purpose of this study is to evaluate the efficacy 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 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
- 350 participants
- Where
- 345 sitesin 27 countries
- Study dates
- 19 Jan 2022to 30 Oct 2028
- Phase
- Phase 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
- Diagnosis of Crohn's disease (CD) of at least 3 months in duration
- Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Who cannot join
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
- Unstable doses of concomitant Crohn's disease therapy
Trial locations and contacts
345 sites in 27 countries.
345 sites in 27 countries
United States77 sites
Clinnova Research
Anaheim, California, 92805
Atlanta Gastroenterology Specialists, PC
Atlanta, Georgia, 30224
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Institute for Digestive Health and Liver Disease
Baltimore, Maryland, 21202-2102
USF Asthma, Allergy, Immunology Clinical Research Unit
Boise, Idaho, 83706
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Burke Internal Medicine and Research
Burke, Virginia, 22015
Advanced Gastro P.C
Chandler, Arizona, 85224-1636
Carolinas Medical Center
Charlotte, North Carolina, 28207
Onsite Clinical Solutions
Charlotte, North Carolina, 28277
Digestive Health Specialists PC
Chelmsford, Massachusetts, 01824
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Gastroenterology Associates of SW Florida
Clearwater, Florida, 33762-5323
Pioneer Research Solutions Inc.
Coconut Creek, Florida, 33066
Central Ohio Endoscopy Center LLC
Columbus, Ohio, 43214
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017
Western Connecticut Health Network/Danbury Hospital
Danbury, Connecticut, 06810
Dayton Gastroenterology, Inc
Dayton, Ohio, 45440
Omega Research Consultants
DeBary, Florida, 32713
Atlanta Center For Gastroenterology
Decatur, Georgia, 30033
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061
Amel Med LLC Research
Grand Junction, Colorado, 81505-1027
Carolina Research
Greenville, North Carolina, 27834
Gastroenterology Associates P.A.
Greenville, South Carolina, 29615
Harmony Medical Research Institute, Inc.
Hialeah, Florida, 33016
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Smart Medical Research
Jackson Heights, New York, 11372
University of Kansas Medical Center
Kansas City, Kansas, 66103-2937
Central Florida Gastro Research
Kissimmee, Florida, 34741
Om Research LLC 1
Lancaster, California, 93534
Om Research LLC
Lancaster, California, 93534
BVL Clinical Research
Leawood, Kansas, 66211
Moore Clinical Trials, LLC
Little Rock, Arkansas, 72205-6414
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72223
Detroit Clinical Research Center
Livonia, Michigan, 48152
United Gastroenterologists
Los Alamitos, California, 90720
Paul Wallace MD
Los Angeles, California, 90048
West Texas Clinical Research
Lubbock, Texas, 79424
Gastroenterolgy Associates of Central GA
Macon, Georgia, 31201
Tandem Clinical Research
Marrero, Louisiana, 70072
Great Lakes Gastroenterology
Mentor, Ohio, 44060
Community Research Foundation, Inc.
Miami, Florida, 33155
Crystal Run Healthcare LLP
Middletown, New York, 10941
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572
Gastroenterology Group Of Naples
Naples, Florida, 34102
New York Gastroenterology Associates
New York, New York, 10075
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, 11758
Lemah Creek Clinical Research
Oakbrook Terrace, Illinois, 60618
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
Integris Baptist Office
Oklahoma City, Oklahoma, 73112
Central Sooner Research
Oklahoma City, Oklahoma, 73120
Center for Digestive Health
Orlando, Florida, 32803-1853
Central Florida Internists
Orlando, Florida, 32819
Digestive System Healthcare
Pasadena, California, 77505-3950
The Oregon Clinic
Portland, Oregon, 97220-9428
A1 Clinical Network
Queens, New York, 11375
Victoria Gastroenterology
Richmond, Texas, 77407
Gastroenterology Consultants
Roswell, Georgia, 30076-4943
Care Access Research- Salt Lake City
Salt Lake City, Utah, 84124
Gastroenterology Clinic Of San Antonio P A
San Antonio, Texas, 78229
Wellness Clinical Research
San Antonio, Texas, 78232
Northshore Gastroenterology Research, LLC
San Diego, California, 92103-2120
Clinical Applications Laboratories, Inc
San Diego, California, 92103
Santa Maria Gastroenterology
Santa Maria, California, 93454
Reliance Research
Scottsdale, Arizona, 85260
Frontier Clinical Research
Smithfield, Pennsylvania, 15478
FC Research, LLC
South Dartmouth, Massachusetts, 02747
Texas Digestive Disease Consultants
Southlake, Texas, 76092
Synergy Clinical Research
St. Petersburg, Florida, 33705
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606
Essential Medical Research
Tulsa, Oklahoma, 74137-7061
Digestive Health Specialists of Tyler
Tyler, Texas, 75701
Clinical Research of California
Walnut Creek, California, 94598
Gastroenterology Associates of the Piedmont, P.A.
Winston-Salem, North Carolina, 27103
Poland44 sites
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok, 15-322
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85 231
Centrum Medyczne Lukamed Sp z o o
Chojnice, 89 600
Centrum Medyczne Lukamed
Chojnice, 89-600
Sahlgrenska University Hospital
Chrzanów, 32-500
MZ Badania Slowik Zymla Spolka jawna
Knurów, 44 190
Malopolskie Centrum Kliniczne
Krakow, 30 149
Centrum Medyczne Plejady
Krakow, 30 363
Centrum Medyczne ProMiMed
Krakow, 31 637
AmiCare Centrum Medyczne
Lodz, 90-644
IP Clinic Sp. z o.o.
Lodz, 90-752
Centrum Medyczne Med Gastr
Lodz, 91 034
REUMED Zespol Poradni Specjalistycznych Filia nr 2
Lublin, 20 582
ETG Lublin
Lublin, 20-412
Allmedica
Nowy Targ, 34 400
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10 561
Twoja Przychodnia 1
Opole, 45-819
Centrum Medyczne
Piotrkow Trybunalski, 97 300
EMC Instytut Medyczny SA PL CERTUS
Poznan, 60 309
Twoja Przychodnia
Poznan, 61 324
Synexus Polska Sp z o o
Poznan, 61 441
Centrum Medyczne Medyk
Rzeszów, 35-326
Centrum Medyczne Promed
Skorzewo, 60-185
Endoskopia Sp z o.o.
Sopot, 81-756
Kiepury Clinic
Sosnowiec, 41-200
KO Med Centrum Medyczne
Straszów, 28 200
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
Sonomed Sp. z o.o.
Szczecin, 71-685
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, 87 100
H-T Centrum Medyczne Endoterapia
Tychy, 43-100
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw, 00 632
Endoterapia
Warsaw, 02 653
Medical Concierge Centrum Medyczne
Warsaw, 02 798
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, 02-507
NZOZ Vivamed
Warsaw, 03 580
Gabinety Lekarskie Bodyclinic
Warsaw, 03-712
IBD Point Profesor Kierkus
Warsaw, 04-501
Centrum Zdrowia Tuchow
Wierzchosławice, 33-122
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Włocławek, 87-800
Centrum Medyczne Melita Medical 2
Wroclaw, 50-449
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, 50-556
Przychodnia Vistamed
Wroclaw, 53 149
Centrum Medyczne Melita Medical
Wroclaw, 53 611
Pro Life Medica Sp z o o ETG Zamosc
Zamość, 22-400
Japan42 sites
Juntendo University Hospital
Bunkyō City, 113-8431
Ginza central clinic
Chūōku, 1040061
Fukui Prefectural Hospital
Fukui-ken, 910-8526
Fukuoka University Hospital
Fukuoka, 814-0180
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555
National Hospital Organization Fukuyama Medical Center
Fukuyama, 720-8520
Gamagori City Hospital
Gamagōri, 443-8501
Gunma University Hospital
Gunma, 371-0034
Hachinohe City Hospital
Hachinohe, 031-8555
Hamamatsu University Hospital
Hamamatsu, 431 3192
Matsuda Hospital
Hamamatsu, 432-8061
National Hospital Organization Mito Medical Center
Higashi-Ibaraki, 311-3193
Kure Kyosai Hospital
Hiroshima, 737-8505
National Hospital Organization Shikoku Cancer Center
Iizuka-shi, 820-8505
Kagoshima University Hospital
Kagoshima, 890-8520
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871
Kyushu Rosai Hospital
Kitakyushu, 800-0229
Kobe University Hospital
Kobe, 650 0017
Yamanashi Prefectural Central Hospital
Kofu, 400-8506
Dokkyo Medical University Saitama Medical Center
Koshigaya, 343-8555
Hidaka Coloproctologic Clinic
Kurume, 839-0809
Japanese Red Cross Kyoto Daini Hospital
Kyoto, 602-8026
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Iwate Medical University Hospital
Morioka, 020-8505
Nagasaki University Hospital
Nagasaki, 852-8501
Yokoyama IBD Clinic
Nagoya, 460-0022
University of the Ryukyus Hospital
Nakagami-gun, 901-2132
Niigata University Medical And Dental Hospital
Niigata, 951 8520
Nishinomiya Municipal Central Hospital
Nishinomiya, 663-8014
Oita Red Cross Hospital
Ōita, 870-0033
Kinshukai Infusion Clinic
Osaka, 530-0011
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Japanese Red Cross Osaka Hospital
Osaka, 543-8555
Osaka General Medical Center
Osaka, 558-8558
Shiga University of Medical Science Hospital
Ōtsu, 520-2192
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033
Takagi Clinic
Sendai, 981-3213
National Hospital Organization Shizuoka Medical Center
Sunto-gun, 411-8611
Tokyo Medical University Hospital
Tokyo, 160-0023
Toyota Kosei Hospital
Toyota, 470-0396
Yokohama City University Medical Center
Yokohama, 232 0024
Brazil28 sites
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, 18608-025
CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
Brasília, 70200-730
Chronos Clinica Medica Ltda
Brasília, 72145 450
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, 13060-904
CDC - Centro Digestivo de Curitiba
Curitiba, 80430-180
Universidade Federal Do Ceara
Fortaleza, 60430-370
Centro de Estudos Clínicos do Interior Paulista - CECIP
Jaú, 17201-130
Cliged
Macaé, 27910-020
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000
Instituto Mederi de Pesquisa e Saude
Passo Fundo, 99010-120
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-003
Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
Porto Alegre, 90160-092
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, 90430-001
Hospital das Clinicas - Universidade Federal de Pernambuco
Recife, 51011040
Universidade Federal da Bahia - Hospital Professor Edgard Santos
Salvador, 40110-060
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, 40150150
Pesquisare Saude
Santo André, 09080-110
Irmandade da Santa Casa da Misericórdia de Santos
Santos, 11075-101
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09715-090
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
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo, 03325-050
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo, 04039-004
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 04543-000
Hepatogastro
São Paulo, 04543-011
Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
Teresina, 64049-550
Integral Centro de Pesquisas Clinicas
Votuporanga, 15501 405
China26 sites
The Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
Xiangya Hospital Central South University
Changsha, 410008
The second Xiangya Hospital of Central South University
Changsha, 410011
Changzhou No 2 Peoples Hospital
Changzhou, 213004
West China Hospital Sichuan University
Chengdu, 610041
Chongqing Medical University
Chongqing, 400013
The First People's Hospital of Foshan
Foshan, 528010
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005
First Affiliated Hospital of Gannan Medical University
Ganzhou, 341000
Guangdong Provincial People's Hospital
Guangzhou, 510080
Guangzhou First Municipal People's Hospital
Guangzhou, 510180
Guangzhou Medical University
Guangzhou, 510260
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, 310006
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
The First Affiliated Hospital of NanChang University
Nanchang, 330006
Nanjing 1st Hospital
Nanjing, 210006
Nanjing Drum Tower Hospital
Nanjing, 210008
The First Hospital of Quanzhou
Quanzhou, 362002
Huashan Hospital Fudan University
Shanghai, 200040
Shanghai East Hospital
Shanghai, 200120
Shengjing Hospital Of China Medical University
Shenyang, 110022
The first affiliated hospital of suzhou University
Suzhou
Wuxi People s Hospital
Wuxi, 214023
Yangzhou First People's Hospital
Yangzhou, 225001
ZhuZhou Central Hospital
Zhuzhou, 412007
South Korea18 sites
Kyungpook National University Chilgok Hospital
Busan, 41404
Inje University Haeundae Paik Hospital
Busan, 48108
Kosin University Gospel Hospital
Busan, 49267
DongA Medical Center
Busan, 602739
Yeungnam University Medical Center
Daegu, 42415
The Catholic University of Korea Seoul St.Mary's Hospital
Daejeon, 34943
Kyung Hee University Hospital
Dongdaemun-gu, 02447
Dongguk University Ilsan Hospital
Goyang-si, 10326
Chonnam National University Hospital
Gwangju, 61469
CHA Bundang Medical Center, CHA University
Gyeonggi-do, 13496
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, 16247
Kangbuk Samsung Hospital
Seoul, 03181
Yonsei University College of Medicine
Seoul, 03722
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
Ajou University Hospital
Suwon, 16499
Wonju Christian Hospital
Wŏnju, 26426
Ewha Womans University Mokdong Hospital
Yangch’ŏn-gu, 07985
Germany13 sites
Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
Berlin, 10117
CED Studienzentrum Karlshorst
Berlin, 10318
DRK Kliniken Westend
Berlin, 14050
Krankenhaus Waldfriede Mitte
Berlin, 14163
Staedtisches Klinikum Braunschweig
Braunschweig, 38126
Evangelisches Krankenhaus Kalk
Cologne, 51103
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau, 85221
MVZ Sanaklinikum Duisburg
Duisburg, 47055
Studiengesellschaft Mitteldeutschland GmbH
Halle, 6108
Medizinische Hochschule Hannover
Hanover, 30625
Praxisgemeinschaft Jerichow
Jerichow, 39319
Universitaetsklinikum Mannheim
Mannheim, 68167
Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
Nordhausen, 99734
France11 sites
Centre Hospitalier de la Cote Basque
Bayonne, 64100
CHRU Besancon Hopital Jean Minjoz
Besançon, 25000
Hopital Louis Mourier
Colombes, 92701
CHU de Nantes hotel Dieu
Nantes, 44093
CHU de Nice Hopital de l Archet
Nice, 06202
Hôpital Bichat
Paris, 75877
Hospices Civils de Lyon HCL
Pierre-Bénite, 69495
Hôpital Robert Debré
Reims, 51092
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270
CHRU Strasbourg
Strasbourg, 67098
CHU Rangueil
Toulouse, 31059
Hungary10 sites
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036
Egyesített Szent István és Szent László Kórház
Budapest, 1097
Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
Budapest, 1125
Mh Egészségügyi Központ
Budapest, 1126
Semmelweis Egyetem
Budapest, H-1088
Pannónia Magánorvosi Centrum Kft
Budapest, H-1136
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143
Mohacsi Korhaz
Mohács, 7700
Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
Pécs, 7624
Markusovszky Egyetemi Oktatokorhaz
Szombathely, H-9700
Turkey (Türkiye)8 sites
Ankara Numune Egitim ve Arastirma Hastanesi
Ankara, 06100
Hacettepe University Hospital
Ankara, 06230
Gazi University Medical Faculty
Ankara, 06560
Acibadem Fulya Hospital
Istanbul, 34349
Ege Universitesi Tip Fakultesi
Izmir, 35040
Mersin University Medical Faculty
Mersin, 33343
Ondokuz Mayis University
Samsun, 55420
Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
Zonguldak, 67000
Spain7 sites
Hosp. de Cabuenes
Gijón, 33394
Hosp. Gral. Juan Ramon Jimenez 1
Huelva, 21002
Hosp. Gral. Juan Ramon Jimenez
Huelva, 21005
Hosp. Univ. Infanta Leonor
Madrid, 28031
Hosp. Virgen Macarena
Seville, 41009
Hosp. Alvaro Cunqueiro
Vigo, 36213
Hosp. de La Marina Baixa
Villajoyosa, 03570
Bosnia and Herzegovina6 sites
University hospital Clinical centre Banja Luka
Banja Luka, 78000
Clinical Center University of Sarajevo
Sarajevo, 71000
Polyclinic Dr. Al-Tawil
Sarajevo, 71000
General Hospital Tesanj
Tešanj, 74260
Plava poliklinika Tuzla
Tuzla, 75000
Cantonal Hospital Zenica
Zenica, 72000
Jordan6 sites
Khalidi Hospital and Medical Center
Amman, 11183
The Speciality Hospital (TSH) / Advanced Clinical Center
Amman, 11194
Istiklal Hospital
Amman, 11196
Abdali Hospital
Amman, 1184
Irbid Specialty Hospital
Irbid, 21110
Pharmaceutical Research Center Jordan University of Science and Technology Rheumatology
Irbid, 22110
Belgium5 sites
OLV Ziekenhuis Aalst
Aalst, 9300
CHU Saint-Pierre
Brussels, 1000
Hopital Erasme
Brussels, 1070
Universitair Ziekenhuis Gent
Ghent, 9000
Algemeen Ziekenhuis Delta
Roeselare, 8800
Czechia5 sites
Fakultni nemocnice Brno
Brno, 636 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Oblastni nemocnice Kladno a.s.
Kladno, 27259
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Nemocnice Slany
Slaný, 274 01
Israel5 sites
Haemek Medical Center
Afula, 1834111
Soroka University Medical Center
Beersheba, 84101
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Kaplan Medical Center
Rehovot, 76100
Assaf Harofeh Medical Center
Tzrifin, 70300
Malaysia5 sites
Hospital Sultanah Aminah
Johor Bharu, 80100
Hospital University Sains Malaysia
Kota Bharu, 16150
Hospital Raja Permaisuri Bainun
Kota Kinabalu, 88586
University Malaya Medical Centre
Kuala Lumpur, 59100
Hospital Tengku Ampuan Afzan
Kuantan, 25100
Taiwan5 sites
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaoshiung, 80756
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital, Division of Infectious Diseases
Taipei, 100
Taipei Medical University
Taipei, 110301
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Croatia4 sites
Opca bolnica Bjelovar
Bjelovar, 43000
University Hospital Center Split
Split, 21000
Opca bolnica Zadar
Zadar, 23000
Poliklinika Solmed
Zagreb, 10000
Italy4 sites
Policlinico Sant'Orsola Malpighi
Bologna, 40138
Istituto Clinico Humanitas Rozzano, IRCCS
Milan, 20132
Università Campus Biomedico di Roma
Roma, 00128
Policlinico Universitario Agostino Gemelli
Roma, 168
Netherlands3 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
Sint Franciscus Gasthuis
Rotterdam, 3045 PM
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
Slovakia3 sites
FNsP F.D.R. Banska Bystrica
Banská Bystrica, 974 01
ENDOMED s.r.o
Košice, 040 13
GASTRO I. s.r.o.
Prešov, 080 01
Australia2 sites
Monash Health, Monash Medical Centre
Clayton, 3168
Coral Sea Clinical Research Institute
North Mackay, 4740
Canada2 sites
London Health Sciences Centre
London, Ontario, N6A 5A5
North Bay Dermatology Centre
North Bay, Ontario, P1B 2H3
Denmark2 sites
Sydvestjysk Sygehus
Esbjerg, 6700
Nordsjaellands Hospital - Hillerod
Hilleroed, 3400
Lithuania2 sites
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas, 44307
Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, LT-08661
New Zealand2 sites
Christchurch Hospital
Christchurch, 8011
Dunedin Hospital
Dunedin, 9016
About this study
Official title: CNTO1959CRD3004: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
- Conditions
- Crohn Disease
- Being tested
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Placebo
- 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 (Dose 1) will be administered by subcutaneous (SC) injection.
Guselkumab Dose 2Drug
Guselkumab (Dose 2) will be administered by SC injection.
Guselkumab Dose 3Drug
Guselkumab (Dose 3) will be administered by SC injection.
PlaceboDrug
Placebo will be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Guselkumab | Experimental | Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously. Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2 |
| Group 2: Guselkumab | Experimental | Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously. Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 3 |
| Group 3: Placebo | Placebo comparator | Participants will receive placebo injection subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Clinical Remission at Week 12
Clinical remission was defined as a Crohn's Disease Activity Index (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 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
Measured: At Week 12
Percentage of Participants Who Achieved Endoscopic Response at Week 12
Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Measured: At Week 12
Secondary outcomes (6)
Percentage of Participants Who Achieved Clinical Remission at Week 24
Percentage of participants who achieved clinical remission at Week 24 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (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 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
Measured: At Week 24
Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12
Percentage of participants who achieved PRO-2 remission at Week 12 were reported. PRO-2 remission was defined as an abdominal pain (AP) mean daily score <=1, and stool frequency (SF) mean daily score <=3, and no worsening of AP or SF from baseline. Mean daily AP score based on the CDAI was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score based on the CDAI was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease.
Measured: At Week 12
Percentage of Participants Who Achieved Clinical Response at Week 12
Clinical response was defined as a decrease from baseline in CDAI score >= 100 points or 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 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
Measured: At Week 12
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48
Percentage of participants with TEAEs through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent.
Measured: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48
Percentage of participants with TESAEs through Week 48 were reported. An SAE was any untoward medical occurrence in a clinical study participant resulting in any of the following outcomes or was deemed significant for any other reason: death, life-threatening (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. An AE does not necessarily have a causal relationship with the study drug. Any SAE that occurred at or after the initial administration of study drug (Week 0) through the data cutoff of Week 48 was considered treatment-emergent.
Measured: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48
Percentage of participants with TEAEs leading to discontinuation of study drug through Week 48 were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant participating in a clinical study and does not necessarily have a causal relationship with the study drug. An AE that occurred at or after the initial administration of study drug (Week 0) through data cutoff of Week 48 was considered treatment-emergent.
Measured: Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start19 Jan 2022
- Primary completion4 Jul 2023
- Study completion30 Oct 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 (1)Papers the sponsor has linked to this study.
- Other trials for Crohn 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 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
- NCT05197049
- Sponsor's protocol ID
- CR109125
- Other IDs
- CNTO1959CRD3004, 2020-006165-11, 2023-504737-41-00, 2023
- Acronym
- GRAVITI
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2022
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Hart A, Panaccione R, Steinwurz F, Danese S, Hisamatsu T, Cao Q, Ritter T, Seidler U, Olurinde M, Vetter ML, Yee J, Yang Z, Wang Y, Johanns J, Han C, Sahoo A, Terry NA, Sands BE, D'Haens G; GRAVITI Study Group. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study. Gastroenterology. 2025 Aug;169(2):308-325. doi: 10.1053/j.gastro.2025.02.033. Epub 2025 Mar 18.
PubMed 40113101