A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease (GRAVITI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Placebo; Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2; Drug: Guselkumab Dose 3

Detailed Description

Crohn's disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease. The overall study duration is up to 109 weeks.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Clayton, Australia, 3168
    • Monash Health, Monash Medical Centre
  • North Mackay, Australia, 4740
    • Coral Sea Clinical Research Institute
• Belgium
  • Aalst, Belgium, 9300
    • OLV Ziekenhuis Aalst
  • Brussels, Belgium, 1070
    • Hopital Erasme
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University hospital Clinical centre Banja Luka
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinical Center University of Sarajevo
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Polyclinic Dr. Al-Tawil
  • Tešanj, Bosnia and Herzegovina, 74260
    • General Hospital Tesanj
  • Tuzla, Bosnia and Herzegovina, 75000
    • Plava poliklinika Tuzla
  • Zenica, Bosnia and Herzegovina, 72000
    • Cantonal Hospital Zenica
• Brazil
  • Botucatu, Brazil, 18608-025
    • Universidade Estadual Paulista 'Julio De Mesquita Filho'
  • Brasília, Brazil, 70200-730
    • CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
  • Brasília, Brazil, 72145 450
    • Chronos Clinica Medica Ltda
  • Campinas, Brazil, 13060-904
    • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
  • Curitiba, Brazil, 80430-180
    • CDC - Centro Digestivo de Curitiba
  • Fortaleza, Brazil, 60430-370
    • Universidade Federal Do Ceara
  • Jaú, Brazil, 17201-130
    • Centro de Estudos Clínicos do Interior Paulista - CECIP
  • Macaé, Brazil, 27910-020
    • Cliged
  • Natal, Brazil, 59062 000
    • Liga Norte Riograndense Contra O Cancer
  • Passo Fundo, Brazil, 99010-120
    • Instituto Mederi de Pesquisa e Saude
  • Porto Alegre, Brazil, 90035-003
    • Hospital das Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 90035-001
    • Associacao Hospitalar Moinhos de Vento
  • Porto Alegre, Brazil, 90160-092
    • Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
  • Porto Alegre, Brazil, 90430-001
    • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
  • Recife, Brazil, 51011040
    • Hospital das Clinicas - Universidade Federal de Pernambuco
  • Salvador, Brazil, 40110-060
    • Universidade Federal da Bahia - Hospital Professor Edgard Santos
  • Salvador, Brazil, 40150150
    • SER - Servicos Especializados em Reumatologia da Bahia
  • Santo André, Brazil, 09080-110
    • Pesquisare Saude
  • Santos, Brazil, 11075-101
    • Irmandade da Santa Casa da Misericórdia de Santos
  • São Bernardo do Campo, Brazil, 09715-090
    • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • São José do Rio Preto, Brazil, 15015-110
    • Kaiser Hospta
  • São José do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
  • São Paulo, Brazil, 04543-000
    • Instituto D Or de Pesquisa e Ensino IDOR
  • São Paulo, Brazil, 03325-050
    • BR TRIALS Ensaios Clinicos e Consultoria Ltda
  • São Paulo, Brazil, 04039-004
    • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  • São Paulo, Brazil, 04543-011
    • Hepatogastro
  • Teresina, Brazil, 64049-550
    • Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
  • Votuporanga, Brazil, 15501 405
    • Integral Centro de Pesquisas Clinicas
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • North Bay, Ontario, Canada, P1B 2H3
      • North Bay Dermatology Centre
• China
  • Bengbu, China, 233004
    • The Affiliated Hospital of Bengbu Medical College
  • Changsha, China, 410008
    • Xiangya Hospital Central South University
  • Changsha, China, 410011
    • The second Xiangya hospital of central south university
  • Changzhou, China, 213004
    • Changzhou No 2 Peoples Hospital
  • Chengdu, China, 610041
    • West China Hospital Sichuan University
  • Chongqing, China, 400013
    • Chongqing Medical University
  • Foshan, China, 528010
    • The First People's Hospital of Foshan
  • Fuzhou, China, 350005
    • The First Affiliated Hospital of Fujian Medical University
  • Ganzhou, China, 341000
    • First Affiliated Hospital of Gannan Medical University
  • Guangzhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510260
    • Guangzhou Medical University
  • Hangzhou, China, 310006
    • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Hefei, China, 230022
    • The First Affiliated Hospital of Anhui Medical University
  • Nanchang, China, 330006
    • The First Affiliated Hospital of NanChang University
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 210006
    • Nanjing 1st Hospital
  • Quanzhou, China, 362002
    • The First Hospital of Quanzhou
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University
  • Shanghai, China, 200120
    • Shanghai East Hospital
  • Shenyang, China, 110022
    • Shengjing Hospital Of China Medical University
  • Suzhou, China
    • The first affiliated hospital of suzhou University
  • Wuxi, China, 214023
    • Wuxi People s Hospital
  • Yangzhou, China, 225001
    • Yangzhou First People's Hospital
  • Zhuzhou, China, 412007
    • ZhuZhou Central Hospital
• Croatia
  • Bjelovar, Croatia, 43000
    • Opca bolnica Bjelovar
  • Split, Croatia, 21000
    • University Hospital Center Split
  • Zadar, Croatia, 23000
    • Opca bolnica Zadar
  • Zagreb, Croatia, 10000
    • Poliklinika Solmed
• Czechia
  • Brno, Czechia, 636 00
    • Fakultni nemocnice Brno
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Kladno, Czechia, 27259
    • Oblastni nemocnice Kladno a.s.
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Slaný, Czechia, 274 01
    • Nemocnice Slany
• Denmark
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Sygehus
  • Hilleroed, Denmark, 3400
    • Nordsjaellands Hospital - Hillerod
• France
  • Bayonne, France, 64100
    • Centre Hospitalier de la Cote Basque
  • Besançon, France, 25000
    • CHRU Besancon Hopital Jean Minjoz
  • Colombes, France, 92701
    • Hôpital Louis Mourier
  • Nantes, France, 44093
    • CHU de Nantes hotel Dieu
  • Nice, France, 06202
    • CHU de Nice Hopital de l Archet
  • Paris, France, 75877
    • Hôpital Bichat
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon HCL
  • Reims, France, 51092
    • Hôpital Robert Debré
  • Saint-Priest-en-Jarez, France, 42270
    • CHU Saint Etienne Hopital Nord
  • Strasbourg, France, 67098
    • CHRU Strasbourg
  • Toulouse, France, 31059
    • CHU Rangueil
• Germany
  • Berlin, Germany, 14050
    • DRK Kliniken Westend
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede Mitte
  • Berlin, Germany, 10117
    • Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
  • Braunschweig, Germany, 38126
    • Staedtisches Klinikum Braunschweig
  • Cologne, Germany, 51103
    • Evangelisches Krankenhaus Kalk
  • Dachau, Germany, 85221
    • Medizinisches Versorgungszentrum (MVZ) Dachau
  • Duisburg, Germany, 47055
    • MVZ Sanaklinikum Duisburg
  • Halle, Germany, 6108
    • BSF Studiengesellschaft
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Jerichow, Germany, 39319
    • Praxisgemeinschaft Jerichow
  • Karlshorst, Germany, 10318
    • Gastroenterologische Spezialpraxis - Berlin-Karlshorst
  • Mannheim, Germany, 68167
    • Universitaetsklinikum Mannheim
  • Nordhausen, Germany, 99734
    • Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Budapest, Hungary, H-1088
    • Semmelweis Egyetem
  • Budapest, Hungary, H-1136
    • Pannónia Magánorvosi Centrum Kft
  • Budapest, Hungary, 1097
    • Egyesített Szent István és Szent László Kórház
  • Budapest, Hungary, 1126
    • Mh Egészségügyi Központ
  • Budapest, Hungary, 1125
    • Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Mohács, Hungary, 7700
    • Mohacsi Korhaz
  • Pécs, Hungary, 7624
    • Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
  • Szombathely, Hungary, H-9700
    • Markusovszky Egyetemi Oktatokorhaz
• Israel
  • Afula, Israel, 1834111
    • Haemek Medical Center
  • Beersheba, Israel, 84101
    • Soroka University Medical Center
  • Ramat Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Tzrifin, Israel, 70300
    • Assaf Harofeh Medical Center
• Italy
  • Bologna, Italy, 40138
    • Policlinico Sant'Orsola Malpighi
  • Milan, Italy, 20132
    • Istituto Clinico Humanitas Rozzano, IRCCS
  • Roma, Italy, 168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00128
    • Università Campus Biomedico di Roma
• Japan
  • Bunkyō City, Japan, 113-8431
    • Juntendo University Hospital
  • Chūōku, Japan, 1040061
    • Ginza central clinic
  • Fukui-ken, Japan, 910-8526
    • Fukui Prefectural Hospital
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Fukuoka, Japan, 815-8555
    • Japanese Red Cross Fukuoka Hospital
  • Fukuyama, Japan, 720-8520
    • National Hospital Organization Fukuyama Medical Center
  • Gamagōri, Japan, 443-8501
    • Gamagori City Hospital
  • Gunma, Japan, 371-0034
    • Gunma University Hospital
  • Hachinohe, Japan, 031-8555
    • Hachinohe City Hospital
  • Hamamatsu, Japan, 431 3192
    • Hamamatsu University Hospital
  • Hamamatsu, Japan, 432-8061
    • Matsuda Hospital
  • Higashi-Ibaraki, Japan, 311-3193
    • National Hospital Organization Mito Medical Center
  • Hiroshima, Japan, 737-8505
    • Kure Kyosai Hospital
  • Iizuka-shi, Japan, 820-8505
    • National Hospital Organization Shikoku Cancer Center
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kagoshima, Japan, 892-0843
    • Kagoshima IBD Gastroenterology Clinic
  • Kashiwa, Japan, 277-0871
    • Tsujinaka Hospital Kashiwanoha
  • Kitakyushu, Japan, 800-0229
    • Kyushu Rosai Hospital
  • Kobe, Japan, 650 0017
    • Kobe University Hospital
  • Kofu, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
  • Koshigaya, Japan, 343-8555
    • Dokkyo Medical University Saitama Medical Center
  • Kurume, Japan, 839-0809
    • Hidaka Coloproctologic Clinic
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Kyoto, Japan, 602-8026
    • Japanese Red Cross Kyoto Daini Hospital
  • Morioka, Japan, 020-8505
    • Iwate Medical University Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Nagoya, Japan, 460-0022
    • Yokoyama IBD Clinic
  • Nakagami-gun, Japan, 901-2132
    • University of the Ryukyus Hospital
  • Niigata, Japan, 951 8520
    • Niigata University Medical And Dental Hospital
  • Nishinomiya, Japan, 663-8014
    • Nishinomiya Municipal Central Hospital
  • Osaka, Japan, 540-0006
    • National Hospital Organization Osaka National Hospital
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Osaka, Japan, 543-8555
    • Japanese Red Cross Osaka Hospital
  • Osaka, Japan, 530-0011
    • Kinshukai Infusion Clinic
  • Sapporo, Japan, 065-0033
    • Sapporo Higashi Tokushukai Hospital
  • Sendai, Japan, 981-3213
    • Takagi Clinic
  • Sunto-gun, Japan, 411-8611
    • National Hospital Organization Shizuoka Medical Center
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Toyota, Japan, 470-0396
    • Toyota Kosei Hospital
  • Yokohama, Japan, 232 0024
    • Yokohama City University Medical Center
  • Ōita, Japan, 870-0033
    • Oita Red Cross Hospital
  • Ōtsu, Japan, 520-2192
    • Shiga University of Medical Science Hospital
• Jordan
  • Amman, Jordan, 11183
    • Khalidi Hospital and Medical Center
  • Amman, Jordan, 11194
    • The Speciality Hospital (TSH) / Advanced Clinical Center
  • Amman, Jordan, 11196
    • Istiklal Hospital
  • Amman, Jordan, 1184
    • Abdali Hospital
  • Irbid, Jordan, 22110
    • King Abdullah University Hospital
  • Irbid, Jordan, 21110
    • Irbid Specialty Hospital
• Lithuania
  • Kaunas, Lithuania, 44307
    • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos, Public Institution
• Malaysia
  • Johor Bharu, Malaysia, 80100
    • Hospital Sultanah Aminah
  • Kota Bharu, Malaysia, 16150
    • Hospital University Sains Malaysia
  • Kota Kinabalu, Malaysia, 88586
    • Hospital Raja Permaisuri Bainun
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuantan, Malaysia, 25100
    • Hospital Tengku Ampuan Afzan
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis
  • Rotterdam, Netherlands, 3045 PM
    • Sint Franciscus Gasthuis
  • Tilburg, Netherlands, 5022 GC
    • Elisabeth-TweeSteden Ziekenhuis
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
• Poland
  • Bialystok, Poland, 15-322
    • Gastromed Kralisz Romatowski Stachurska Sp. j.
  • Bydgoszcz, Poland, 85-681
    • 10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ
  • Chojnice, Poland, 89-600
    • Centrum Medyczne Lukamed
  • Chrzanów, Poland, 32-500
    • Sahlgrenska University Hospital
  • Gdynia, Poland, 81-157
    • Private Practice - Dr. Krzysztof Cymerman
  • Grudziądz, Poland, 86-300
    • Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.
  • Krakow, Poland, 30 149
    • Malopolskie Centrum Kliniczne
  • Krakow, Poland, 30 363
    • Centrum Medyczne Plejady
  • Krakow, Poland, 31 637
    • Centrum Medyczne ProMiMed
  • Lodz, Poland, 90-644
    • AmiCare Centrum Medyczne
  • Lodz, Poland, 90-752
    • IP Clinic Sp. z o.o.
  • Lodz, Poland, 91 034
    • Centrum Medyczne Med Gastr
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Lublin, Poland, 20-582
    • Niepubliczny Zaklad Opieki Zdrowotnej
  • Nowy Targ, Poland, 34 400
    • Allmedica
  • Olsztyn, Poland, 10 561
    • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Opole, Poland, 45-819
    • Twoja Przychodnia 1
  • Piotrkow Trybunalski, Poland, 97 300
    • Centrum Medyczne
  • Poznan, Poland, 61-293
    • Twoja Przychodnia
  • Poznan, Poland, 60 309
    • EMC Instytut Medyczny SA PL CERTUS
  • Poznan, Poland, 61 441
    • Synexus Polska Sp z o o
  • Rzeszów, Poland, 35-326
    • Centrum Medyczne MEDYK
  • Skorzewo, Poland, 60-185
    • Centrum Medyczne Promed
  • Sopot, Poland, 81-756
    • Endoskopia Sp z o.o.
  • Sosnowiec, Poland, 41-200
    • Kiepury Clinic
  • Straszów, Poland, 28 200
    • KO Med Centrum Medyczne
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Szczecin, Poland, 71-685
    • Sonomed Sp. z o.o.
  • Torun, Poland, 87 100
    • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
  • Tychy, Poland, 43-100
    • H-T Centrum Medyczne Endoterapia
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Warsaw, Poland, 02 653
    • Endoterapia
  • Warsaw, Poland, 00 632
    • Centrum Zdrowia Matki Dziecka i Mlodziezy
  • Warsaw, Poland, 02 798
    • Medical Concierge Centrum Medyczne
  • Warsaw, Poland, 03 580
    • NZOZ Vivamed
  • Warsaw, Poland, 03-712
    • Gabinety Lekarskie Bodyclinic
  • Warsaw, Poland, 04-501
    • IBD Point Profesor Kierkus
  • Wierzchosławice, Poland, 33-122
    • Centrum Zdrowia Tuchow
  • Wroclaw, Poland, 50-449
    • Centrum Medyczne Melita Medical
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
  • Wroclaw, Poland, 50 449
    • Melita Medical Sp. z o.o.
  • Wroclaw, Poland, 53 149
    • Przychodnia Vistamed
  • Włocławek, Poland, 87-800
    • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
  • Zamość, Poland, 22-400
    • ETG Zamosc
• Slovakia
  • Banská Bystrica, Slovakia, 974 01
    • FNsP F.D.R. Banska Bystrica
  • Košice, Slovakia, 040 13
    • ENDOMED s.r.o
  • Prešov, Slovakia, 080 01
    • GASTRO I. s.r.o.
• South Korea
  • Busan, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Busan, South Korea, 49267
    • Kosin University Gospel Hospital
  • Busan, South Korea, 602739
    • DongA Medical Center
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center
  • Daejeon, South Korea, 34943
    • The Catholic University of Korea Seoul St.Mary's Hospital
  • Dongdaemun-gu, South Korea, 02447
    • Kyung Hee University Hospital
  • Goyang-si, South Korea, 10326
    • Dongguk University Ilsan Hospital
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, South Korea, 16247
    • The Catholic university of Korea, St. Vincent's Hospital
  • Gyeonggi-do, South Korea, 13496
    • CHA Bundang Medical Center, CHA University
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 03722
    • Yonsei University College of Medicine
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Suwon, South Korea, 16499
    • Ajou University Hospital
  • Wŏnju, South Korea, 26426
    • Wonju Christian Hospital
  • Yangch’ŏn-gu, South Korea, 07985
    • Ewha Womans University Mokdong Hospital
• Spain
  • Gijón, Spain, 33394
    • Hosp. de Cabuenes
  • Huelva, Spain, 21005
    • Hosp. Gral. Juan Ramon Jimenez
  • Huelva, Spain, 21002
    • Hosp. Gral. Juan Ramon Jimenez 1
  • Madrid, Spain, 28031
    • Hosp. Univ. Infanta Leonor
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
  • Vigo, Spain, 36213
    • Hosp. Alvaro Cunqueiro
  • Villajoyosa, Spain, 03570
    • Hosp. de La Marina Baixa
• Taiwan
  • Kaoshiung, Taiwan, 80756
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital, Division of Infectious Diseases
  • Taipei, Taiwan, 110301
    • Taipei Medical University
  • Taoyuan, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Ankara Numune Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Hospital
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34349
    • Acibadem Fulya Hospital
  • Izmir, Turkey (Türkiye), 35040
    • Ege Universitesi Tip Fakultesi
  • Mersin, Turkey (Türkiye), 33343
    • Mersin University Medical Faculty
  • Samsun, Turkey (Türkiye), 55420
    • Ondokuz Mayis University
  • Zonguldak, Turkey (Türkiye), 67000
    • Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists of the Southeast
  • Arizona
    • Chandler, Arizona, United States, 85224-1636
      • Advanced Gastro P.C
    • Scottsdale, Arizona, United States, 85260
      • Reliance Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-6414
      • Moore Clinical Trials, LLC
    • Little Rock, Arkansas, United States, 72223
      • Central Arkansas Veterans Healthcare System
  • California
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Lancaster, California, United States, 93534
      • Om Research LLC 1
    • Los Alamitos, California, United States, 90720
      • United Gastroenterologists
    • Los Angeles, California, United States, 90048
      • Paul Wallace MD
    • Orange, California, United States, 92868
      • Clinnova Research
    • Pasadena, California, United States, 77505-3950
      • Digestive System Healthcare
    • San Diego, California, United States, 92103
      • Clinical Applications Laboratories, Inc
    • San Diego, California, United States, 92103-2120
      • Northshore Gastroenterology Research, LLC
    • Santa Maria, California, United States, 93454
      • Santa Maria Gastroenterology
    • Walnut Creek, California, United States, 94598
      • Clinical Research of California
  • Colorado
    • Grand Junction, Colorado, United States, 81505-1027
      • Amel Med LLC Research
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Western Connecticut Health Network/Danbury Hospital
  • Florida
    • Clearwater, Florida, United States, 33762-5323
      • Gastroenterology Associates of SW Florida
    • Coconut Creek, Florida, United States, 33066
      • Pioneer Research Solutions Inc.
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants
    • Hialeah, Florida, United States, 33016
      • Harmony Medical Research Institute, Inc.
    • Kissimmee, Florida, United States, 34741
      • Central Florida Gastro Research
    • Miami, Florida, United States, 33155
      • Community Research Foundation, Inc.
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Orlando, Florida, United States, 32803-1853
      • Center for Digestive Health
    • Orlando, Florida, United States, 32819
      • Central Florida Internists
    • St. Petersburg, Florida, United States, 33705
      • Synergy Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
    • Atlanta, Georgia, United States, 30224
      • Atlanta Gastroenterology Specialists, PC
    • Decatur, Georgia, United States, 30033
      • Atlanta Center For Gastroenterology
    • Macon, Georgia, United States, 31201
      • Gastroenterolgy Associates of Central GA
    • Roswell, Georgia, United States, 30076-4943
      • Gastroenterology Consultants
  • Idaho
    • Boise, Idaho, United States, 83706
      • USF Asthma, Allergy, Immunology Clinical Research Unit
    • Idaho Falls, Idaho, United States, 83404
      • Grand Teton Research Group, PLLC
  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60618
      • Lemah Creek Clinical Research
  • Kansas
    • Kansas City, Kansas, United States, 66103-2937
      • University of Kansas Medical Center
    • Leawood, Kansas, United States, 66211
      • BVL Clinical Research
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Digestive Health Center
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology Assoc
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21202-2102
      • Institute for Digestive Health and Liver Disease
    • Glen Burnie, Maryland, United States, 21061
      • Woodholme Gastroenterology Associates
  • Massachusetts
    • Chelmsford, Massachusetts, United States, 01824
      • Digestive Health Specialists PC
    • South Dartmouth, Massachusetts, United States, 02747
      • FC Research, LLC
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Livonia, Michigan, United States, 48152
      • Detroit Clinical Research Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY downstate Medical Center
    • Jackson Heights, New York, United States, 11372
      • Smart Medical Research
    • Middletown, New York, United States, 10941
      • Crystal Run Healthcare LLP
    • New York, New York, United States, 10075
      • New York Gastroenterology Associates
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Institute for Medical Education & Research
    • Queens, New York, United States, 11375
      • A1 Clinical Network
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28277
      • Onsite Clinical Solutions
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • Winston-Salem, North Carolina, United States, 27103
      • Gastroenterology Associates of the Piedmont, P.A.
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Central Ohio Endoscopy Center LLC
    • Dayton, Ohio, United States, 45440
      • Dayton Gastroenterology, Inc
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Science Center
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Office
    • Oklahoma City, Oklahoma, United States, 73120
      • Central Sooner Research
    • Tulsa, Oklahoma, United States, 74137-7061
      • Essential Medical Research
  • Oregon
    • Portland, Oregon, United States, 97220-9428
      • The Oregon Clinic
  • Pennsylvania
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Gastroenterology Associates P.A.
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Health Specialists
  • Texas
    • Lubbock, Texas, United States, 79424
      • West Texas Clinical Research
    • Richmond, Texas, United States, 77407
      • Victoria Gastroenterology
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Clinic Of San Antonio P A
    • San Antonio, Texas, United States, 78232
      • Wellness Clinical Research
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants
    • Tyler, Texas, United States, 75701
      • Digestive Health Specialists of Tyler
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Care Access Research- Salt Lake City
  • Virginia
    • Burke, Virginia, United States, 22015
      • Burke Internal Medicine and Research
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Guselkumab; Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.	Drug: Guselkumab Dose 1; Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.; Drug: Guselkumab Dose 2; Guselkumab (Dose 2) will be administered by SC injection.
Experimental: Group 2: Guselkumab; Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.	Drug: Guselkumab Dose 1; Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.; Drug: Guselkumab Dose 3; Guselkumab (Dose 3) will be administered by SC injection.
Placebo Comparator: Group 3: Placebo; Participants will receive placebo injection subcutaneously.	Drug: Placebo; Placebo will be administered by SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): July 4, 2023
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CR109125; 2020-006165-11 (EudraCT Number); CNTO1959CRD3004 (Other Identifier: Janssen Research & Development, LLC); 2023-504737-41-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No