AzTrials
AzTrials

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.

Active, not recruiting

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

Official record

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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

Other trials in United States

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

Other trials in Poland

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

Other trials in Japan

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

Other trials in Brazil

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

Other trials in China

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

Other trials in South Korea

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

Other trials in Germany

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

Other trials in France

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

Other trials in Hungary

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

Other trials in Turkey (Türkiye)

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

Other trials in Spain

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

Other trials in Bosnia and Herzegovina

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

Other trials in Jordan

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

Other trials in Belgium

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

Other trials in Czechia

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

Other trials in Israel

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

Other trials in Malaysia

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

Other trials in Taiwan

Croatia4 sites
  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • University Hospital Center Split

    Split, 21000

  • Opca bolnica Zadar

    Zadar, 23000

  • Poliklinika Solmed

    Zagreb, 10000

Other trials in Croatia

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

Other trials in Italy

Netherlands3 sites
  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

  • Sint Franciscus Gasthuis

    Rotterdam, 3045 PM

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC

Other trials in Netherlands

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

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Australia2 sites
  • Monash Health, Monash Medical Centre

    Clayton, 3168

  • Coral Sea Clinical Research Institute

    North Mackay, 4740

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Canada2 sites
  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 2H3

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Denmark2 sites
  • Sydvestjysk Sygehus

    Esbjerg, 6700

  • Nordsjaellands Hospital - Hillerod

    Hilleroed, 3400

Other trials in Denmark

Lithuania2 sites
  • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

    Kaunas, 44307

  • Vilnius University Hospital Santaros Klinikos, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

New Zealand2 sites
  • Christchurch Hospital

    Christchurch, 8011

  • Dunedin Hospital

    Dunedin, 9016

Other trials in New Zealand

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 groups in NCT05197049
Study groupRoleWhat they receive
Group 1: GuselkumabExperimentalParticipants 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: GuselkumabExperimentalParticipants 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: PlaceboPlacebo comparatorParticipants 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted19 Jan 2022
  2. Study start19 Jan 2022
  3. Primary completion4 Jul 2023
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
350 participants (actual)
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
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

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