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

NCT05197049 | Active Not Recruiting Phase 3 Results FDA Drug

• 4 other identifiers: CR109125CNTO1959CRD30042020-006165-112023-504737-41-00
• Study Type: interventional
• Target: 350
• Locations: 27 countries
• Sites: 345

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percentage of Participants Who Achieved Clinical Remission at Week 24

  At Week 24

• Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12

  At Week 12

• Percentage of Participants Who Achieved Clinical Response at Week 12

  At Week 12

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48

  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

  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

Study Arms (3)

Group 1: Guselkumab

EXPERIMENTAL

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

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.

Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 3

Group 3: Placebo

PLACEBO COMPARATOR

Participants will receive placebo injection subcutaneously.

Drug: Placebo

Interventions

Guselkumab Dose 1 DRUG

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Group 1: Guselkumab; Group 2: Guselkumab

Guselkumab Dose 2 DRUG

Guselkumab (Dose 2) will be administered by SC injection.

Group 1: Guselkumab

Guselkumab Dose 3 DRUG

Guselkumab (Dose 3) will be administered by SC injection.

Group 2: Guselkumab

Placebo DRUG

Placebo will be administered by SC injection.

Group 3: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (345)

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Advanced Gastro P.C

Chandler, Arizona, 85224-1636, United States

Location

Reliance Research

Scottsdale, Arizona, 85260, United States

Location

Moore Clinical Trials, LLC

Little Rock, Arkansas, 72205-6414, United States

Location

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72223, United States

Location

Om Research LLC 1

Lancaster, California, 93534, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

United Gastroenterologists

Los Alamitos, California, 90720, United States

Location

Paul Wallace MD

Los Angeles, California, 90048, United States

Location

Clinnova Research

Orange, California, 92868, United States

Location

Digestive System Healthcare

Pasadena, California, 77505-3950, United States

Location

Northshore Gastroenterology Research, LLC

San Diego, California, 92103-2120, United States

Location

Clinical Applications Laboratories, Inc

San Diego, California, 92103, United States

Location

Santa Maria Gastroenterology

Santa Maria, California, 93454, United States

Location

Clinical Research of California

Walnut Creek, California, 94598, United States

Location

Amel Med LLC Research

Grand Junction, Colorado, 81505-1027, United States

Location

Western Connecticut Health Network/Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Gastroenterology Associates of SW Florida

Clearwater, Florida, 33762-5323, United States

Location

Pioneer Research Solutions Inc.

Coconut Creek, Florida, 33066, United States

Location

Omega Research Consultants

DeBary, Florida, 32713, United States

Location

Harmony Medical Research Institute, Inc.

Hialeah, Florida, 33016, United States

Location

Central Florida Gastro Research

Kissimmee, Florida, 34741, United States

Location

Community Research Foundation, Inc.

Miami, Florida, 33155, United States

Location

Gastroenterology Group Of Naples

Naples, Florida, 34102, United States

Location

Center for Digestive Health

Orlando, Florida, 32803-1853, United States

Location

Central Florida Internists

Orlando, Florida, 32819, United States

Location

Synergy Clinical Research

St. Petersburg, Florida, 33705, United States

Location

Atlanta Gastroenterology Specialists, PC

Atlanta, Georgia, 30224, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

Atlanta Center For Gastroenterology

Decatur, Georgia, 30033, United States

Location

Gastroenterolgy Associates of Central GA

Macon, Georgia, 31201, United States

Location

Gastroenterology Consultants

Roswell, Georgia, 30076-4943, United States

Location

USF Asthma, Allergy, Immunology Clinical Research Unit

Boise, Idaho, 83706, United States

Location

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Lemah Creek Clinical Research

Oakbrook Terrace, Illinois, 60618, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66103-2937, United States

Location

BVL Clinical Research

Leawood, Kansas, 66211, United States

Location

Cotton O'Neil Digestive Health Center

Topeka, Kansas, 66606, United States

Location

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, 41017, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Institute for Digestive Health and Liver Disease

Baltimore, Maryland, 21202-2102, United States

Location

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, 21061, United States

Location

Digestive Health Specialists PC

Chelmsford, Massachusetts, 01824, United States

Location

FC Research, LLC

South Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Detroit Clinical Research Center

Livonia, Michigan, 48152, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Smart Medical Research

Jackson Heights, New York, 11372, United States

Location

Crystal Run Healthcare LLP

Middletown, New York, 10941, United States

Location

New York Gastroenterology Associates

New York, New York, 10075, United States

Location

DiGiovanna Institute for Medical Education & Research

North Massapequa, New York, 11758, United States

Location

A1 Clinical Network

Queens, New York, 11375, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

Onsite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Carolina Research

Greenville, North Carolina, 27834, United States

Location

Gastroenterology Associates of the Piedmont, P.A.

Winston-Salem, North Carolina, 27103, United States

Location

Central Ohio Endoscopy Center LLC

Columbus, Ohio, 43214, United States

Location

Dayton Gastroenterology, Inc

Dayton, Ohio, 45440, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Oklahoma University Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Integris Baptist Office

Oklahoma City, Oklahoma, 73112, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73120, United States

Location

Essential Medical Research

Tulsa, Oklahoma, 74137-7061, United States

Location

The Oregon Clinic

Portland, Oregon, 97220-9428, United States

Location

Frontier Clinical Research

Smithfield, Pennsylvania, 15478, United States

Location

Gastroenterology Associates P.A.

Greenville, South Carolina, 29615, United States

Location

Carolina Health Specialists

Myrtle Beach, South Carolina, 29572, United States

Location

West Texas Clinical Research

Lubbock, Texas, 79424, United States

Location

Victoria Gastroenterology

Richmond, Texas, 77407, United States

Location

Gastroenterology Clinic Of San Antonio P A

San Antonio, Texas, 78229, United States

Location

Wellness Clinical Research

San Antonio, Texas, 78232, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Digestive Health Specialists of Tyler

Tyler, Texas, 75701, United States

Location

Care Access Research- Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Burke Internal Medicine and Research

Burke, Virginia, 22015, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Monash Health, Monash Medical Centre

Clayton, 3168, Australia

Location

Coral Sea Clinical Research Institute

North Mackay, 4740, Australia

Location

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Algemeen Ziekenhuis Delta

Roeselare, 8800, Belgium

Location

University hospital Clinical centre Banja Luka

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Polyclinic Dr. Al-Tawil

Sarajevo, 71000, Bosnia and Herzegovina

Location

General Hospital Tesanj

Tešanj, 74260, Bosnia and Herzegovina

Location

Plava poliklinika Tuzla

Tuzla, 75000, Bosnia and Herzegovina

Location

Cantonal Hospital Zenica

Zenica, 72000, Bosnia and Herzegovina

Location

Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, 18608-025, Brazil

Location

CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia

Brasília, 70200-730, Brazil

Location

Chronos Clinica Medica Ltda

Brasília, 72145 450, Brazil

Location

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, 13060-904, Brazil

Location

CDC - Centro Digestivo de Curitiba

Curitiba, 80430-180, Brazil

Location

Universidade Federal Do Ceara

Fortaleza, 60430-370, Brazil

Location

Centro de Estudos Clínicos do Interior Paulista - CECIP

Jaú, 17201-130, Brazil

Location

Cliged

Macaé, 27910-020, Brazil

Location

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000, Brazil

Location

Instituto Mederi de Pesquisa e Saude

Passo Fundo, 99010-120, Brazil

Location

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035-001, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-003, Brazil

Location

Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles

Porto Alegre, 90160-092, Brazil

Location

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, 90430-001, Brazil

Location

Hospital das Clinicas - Universidade Federal de Pernambuco

Recife, 51011040, Brazil

Location

Universidade Federal da Bahia - Hospital Professor Edgard Santos

Salvador, 40110-060, Brazil

Location

SER - Servicos Especializados em Reumatologia da Bahia

Salvador, 40150150, Brazil

Location

Pesquisare Saude

Santo André, 09080-110, Brazil

Location

Irmandade da Santa Casa da Misericórdia de Santos

Santos, 11075-101, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, 09715-090, Brazil

Location

Kaiser Hospta

São José do Rio Preto, 15015-110, Brazil

Location

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

São José do Rio Preto, 15090-000, Brazil

Location

BR TRIALS Ensaios Clinicos e Consultoria Ltda

São Paulo, 03325-050, Brazil

Location

Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

São Paulo, 04039-004, Brazil

Location

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, 04543-000, Brazil

Location

Hepatogastro

São Paulo, 04543-011, Brazil

Location

Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

Teresina, 64049-550, Brazil

Location

Integral Centro de Pesquisas Clinicas

Votuporanga, 15501 405, Brazil

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 2H3, Canada

Location

The Affiliated Hospital of Bengbu Medical College

Bengbu, 233004, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

The second Xiangya Hospital of Central South University

Changsha, 410011, China

Location

Changzhou No 2 Peoples Hospital

Changzhou, 213004, China

Location

West China Hospital Sichuan University

Chengdu, 610041, China

Location

Chongqing Medical University

Chongqing, 400013, China

Location

The First People's Hospital of Foshan

Foshan, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350005, China

Location

First Affiliated Hospital of Gannan Medical University

Ganzhou, 341000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, 510080, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, 510180, China

Location

Guangzhou Medical University

Guangzhou, 510260, China

Location

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, 310006, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

Location

The First Affiliated Hospital of NanChang University

Nanchang, 330006, China

Location

Nanjing 1st Hospital

Nanjing, 210006, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

The First Hospital of Quanzhou

Quanzhou, 362002, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Shanghai East Hospital

Shanghai, 200120, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110022, China

Location

The first affiliated hospital of suzhou University

Suzhou, China

Location

Wuxi People s Hospital

Wuxi, 214023, China

Location

Yangzhou First People's Hospital

Yangzhou, 225001, China

Location

ZhuZhou Central Hospital

Zhuzhou, 412007, China

Location

Opca bolnica Bjelovar

Bjelovar, 43000, Croatia

Location

University Hospital Center Split

Split, 21000, Croatia

Location

Opca bolnica Zadar

Zadar, 23000, Croatia

Location

Poliklinika Solmed

Zagreb, 10000, Croatia

Location

Fakultni nemocnice Brno

Brno, 636 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Oblastni nemocnice Kladno a.s.

Kladno, 27259, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Nemocnice Slany

Slaný, 274 01, Czechia

Location

Sydvestjysk Sygehus

Esbjerg, 6700, Denmark

Location

Nordsjaellands Hospital - Hillerod

Hilleroed, 3400, Denmark

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

CHRU Besancon Hopital Jean Minjoz

Besançon, 25000, France

Location

Hopital Louis Mourier

Colombes, 92701, France

Location

CHU de Nantes hotel Dieu

Nantes, 44093, France

Location

CHU de Nice Hopital de l Archet

Nice, 06202, France

Location

Hôpital Bichat

Paris, 75877, France

Location

Hospices Civils de Lyon HCL

Pierre-Bénite, 69495, France

Location

Hôpital Robert Debré

Reims, 51092, France

Location

CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, 42270, France

Location

CHRU Strasbourg

Strasbourg, 67098, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

Berlin, 10117, Germany

Location

DRK Kliniken Westend

Berlin, 14050, Germany

Location

Krankenhaus Waldfriede Mitte

Berlin, 14163, Germany

Location

Staedtisches Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Evangelisches Krankenhaus Kalk

Cologne, 51103, Germany

Location

Medizinisches Versorgungszentrum (MVZ) Dachau

Dachau, 85221, Germany

Location

MVZ Sanaklinikum Duisburg

Duisburg, 47055, Germany

Location

BSF Studiengesellschaft

Halle, 6108, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Praxisgemeinschaft Jerichow

Jerichow, 39319, Germany

Location

Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Karlshorst, 10318, Germany

Location

Universitaetsklinikum Mannheim

Mannheim, 68167, Germany

Location

Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum

Nordhausen, 99734, Germany

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Egyesített Szent István és Szent László Kórház

Budapest, 1097, Hungary

Location

Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu

Budapest, 1125, Hungary

Location

Mh Egészségügyi Központ

Budapest, 1126, Hungary

Location

Semmelweis Egyetem

Budapest, H-1088, Hungary

Location

Pannónia Magánorvosi Centrum Kft

Budapest, H-1136, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Mohacsi Korhaz

Mohács, 7700, Hungary

Location

Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

Pécs, 7624, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz

Szombathely, H-9700, Hungary

Location

Haemek Medical Center

Afula, 1834111, Israel

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Assaf Harofeh Medical Center

Tzrifin, 70300, Israel

Location

Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

Istituto Clinico Humanitas Rozzano, IRCCS

Milan, 20132, Italy

Location

Università Campus Biomedico di Roma

Roma, 00128, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 168, Italy

Location

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

Location

Ginza central clinic

Chūōku, 1040061, Japan

Location

Fukui Prefectural Hospital

Fukui-ken, 910-8526, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Japanese Red Cross Fukuoka Hospital

Fukuoka, 815-8555, Japan

Location

National Hospital Organization Fukuyama Medical Center

Fukuyama, 720-8520, Japan

Location

Gamagori City Hospital

Gamagōri, 443-8501, Japan

Location

Gunma University Hospital

Gunma, 371-0034, Japan

Location

Hachinohe City Hospital

Hachinohe, 031-8555, Japan

Location

Hamamatsu University Hospital

Hamamatsu, 431 3192, Japan

Location

Matsuda Hospital

Hamamatsu, 432-8061, Japan

Location

National Hospital Organization Mito Medical Center

Higashi-Ibaraki, 311-3193, Japan

Location

Kure Kyosai Hospital

Hiroshima, 737-8505, Japan

Location

National Hospital Organization Shikoku Cancer Center

Iizuka-shi, 820-8505, Japan

Location

Kagoshima University Hospital

Kagoshima, 890-8520, Japan

Location

Kagoshima IBD Gastroenterology Clinic

Kagoshima, 892-0843, Japan

Location

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871, Japan

Location

Kyushu Rosai Hospital

Kitakyushu, 800-0229, Japan

Location

Kobe University Hospital

Kobe, 650 0017, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, 400-8506, Japan

Location

Dokkyo Medical University Saitama Medical Center

Koshigaya, 343-8555, Japan

Location

Hidaka Coloproctologic Clinic

Kurume, 839-0809, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, 602-8026, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Iwate Medical University Hospital

Morioka, 020-8505, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Yokoyama IBD Clinic

Nagoya, 460-0022, Japan

Location

University of the Ryukyus Hospital

Nakagami-gun, 901-2132, Japan

Location

Niigata University Medical And Dental Hospital

Niigata, 951 8520, Japan

Location

Nishinomiya Municipal Central Hospital

Nishinomiya, 663-8014, Japan

Location

Kinshukai Infusion Clinic

Osaka, 530-0011, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Japanese Red Cross Osaka Hospital

Osaka, 543-8555, Japan

Location

Osaka General Medical Center

Osaka, 558-8558, Japan

Location

Oita Red Cross Hospital

Ōita, 870-0033, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, 520-2192, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033, Japan

Location

Takagi Clinic

Sendai, 981-3213, Japan

Location

National Hospital Organization Shizuoka Medical Center

Sunto-gun, 411-8611, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Toyota Kosei Hospital

Toyota, 470-0396, Japan

Location

Yokohama City University Medical Center

Yokohama, 232 0024, Japan

Location

Khalidi Hospital and Medical Center

Amman, 11183, Jordan

Location

The Speciality Hospital (TSH) / Advanced Clinical Center

Amman, 11194, Jordan

Location

Istiklal Hospital

Amman, 11196, Jordan

Location

Abdali Hospital

Amman, 1184, Jordan

Location

Irbid Specialty Hospital

Irbid, 21110, Jordan

Location

King Abdullah University Hospital

Irbid, 22110, Jordan

Location

Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

Kaunas, 44307, Lithuania

Location

Vilnius University Hospital Santaros Klinikos, Public Institution

Vilnius, LT-08661, Lithuania

Location

Hospital Sultanah Aminah

Johor Bharu, 80100, Malaysia

Location

Hospital University Sains Malaysia

Kota Bharu, 16150, Malaysia

Location

Hospital Raja Permaisuri Bainun

Kota Kinabalu, 88586, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Sint Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Elisabeth-TweeSteden Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Gastromed Kralisz Romatowski Stachurska Sp. j.

Bialystok, 15-322, Poland

Location

10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ

Bydgoszcz, 85-681, Poland

Location

Centrum Medyczne Lukamed

Chojnice, 89-600, Poland

Location

Sahlgrenska University Hospital

Chrzanów, 32-500, Poland

Location

Private Practice - Dr. Krzysztof Cymerman

Gdynia, 81-157, Poland

Location

Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.

Grudziądz, 86-300, Poland

Location

Malopolskie Centrum Kliniczne

Krakow, 30 149, Poland

Location

Centrum Medyczne Plejady

Krakow, 30 363, Poland

Location

Centrum Medyczne ProMiMed

Krakow, 31 637, Poland

Location

AmiCare Centrum Medyczne

Lodz, 90-644, Poland

Location

IP Clinic Sp. z o.o.

Lodz, 90-752, Poland

Location

Centrum Medyczne Med Gastr

Lodz, 91 034, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Lublin, 20-582, Poland

Location

Allmedica

Nowy Targ, 34 400, Poland

Location

Wojewodzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10 561, Poland

Location

Twoja Przychodnia 1

Opole, 45-819, Poland

Location

Centrum Medyczne

Piotrkow Trybunalski, 97 300, Poland

Location

EMC Instytut Medyczny SA PL CERTUS

Poznan, 60 309, Poland

Location

Synexus Polska Sp z o o

Poznan, 61 441, Poland

Location

Twoja Przychodnia

Poznan, 61-293, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-326, Poland

Location

Centrum Medyczne Promed

Skorzewo, 60-185, Poland

Location

Endoskopia Sp z o.o.

Sopot, 81-756, Poland

Location

Kiepury Clinic

Sosnowiec, 41-200, Poland

Location

KO Med Centrum Medyczne

Straszów, 28 200, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

Sonomed Sp. z o.o.

Szczecin, 71-685, Poland

Location

GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii

Torun, 87 100, Poland

Location

H-T Centrum Medyczne Endoterapia

Tychy, 43-100, Poland

Location

Centrum Zdrowia Matki Dziecka i Mlodziezy

Warsaw, 00 632, Poland

Location

Endoterapia

Warsaw, 02 653, Poland

Location

Medical Concierge Centrum Medyczne

Warsaw, 02 798, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, 02-507, Poland

Location

NZOZ Vivamed

Warsaw, 03 580, Poland

Location

Gabinety Lekarskie Bodyclinic

Warsaw, 03-712, Poland

Location

IBD Point Profesor Kierkus

Warsaw, 04-501, Poland

Location

Centrum Zdrowia Tuchow

Wierzchosławice, 33-122, Poland

Location

Melita Medical Sp. z o.o.

Wroclaw, 50 449, Poland

Location

Centrum Medyczne Melita Medical

Wroclaw, 50-449, Poland

Location

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, 50-556, Poland

Location

Przychodnia Vistamed

Wroclaw, 53 149, Poland

Location

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

Włocławek, 87-800, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

FNsP F.D.R. Banska Bystrica

Banská Bystrica, 974 01, Slovakia

Location

ENDOMED s.r.o

Košice, 040 13, Slovakia

Location

GASTRO I. s.r.o.

Prešov, 080 01, Slovakia

Location

Kyungpook National University Chilgok Hospital

Busan, 41404, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

DongA Medical Center

Busan, 602739, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

The Catholic University of Korea Seoul St.Mary's Hospital

Daejeon, 34943, South Korea

Location

Kyung Hee University Hospital

Dongdaemun-gu, 02447, South Korea

Location

Dongguk University Ilsan Hospital

Goyang-si, 10326, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

CHA Bundang Medical Center, CHA University

Gyeonggi-do, 13496, South Korea

Location

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

Gyeonggi-do, 16247, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Wonju Christian Hospital

Wŏnju, 26426, South Korea

Location

Ewha Womans University Mokdong Hospital

Yangch’ŏn-gu, 07985, South Korea

Location

Hosp. de Cabuenes

Gijón, 33394, Spain

Location

Hosp. Gral. Juan Ramon Jimenez 1

Huelva, 21002, Spain

Location

Hosp. Gral. Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36213, Spain

Location

Hosp. de La Marina Baixa

Villajoyosa, 03570, Spain

Location

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaoshiung, 80756, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital, Division of Infectious Diseases

Taipei, 100, Taiwan

Location

Taipei Medical University

Taipei, 110301, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Ankara Numune Egitim ve Arastirma Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

Location

Acibadem Fulya Hospital

Istanbul, 34349, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi

Izmir, 35040, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, 33343, Turkey (Türkiye)

Location

Ondokuz Mayis University

Samsun, 55420, Turkey (Türkiye)

Location

Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi

Zonguldak, 67000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40113101 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Senior Medical Leader IMM
• Organization: Janssen-Cilag International NV

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 19, 2022
• Study Start: January 19, 2022
• Primary Completion: July 4, 2023
• Study Completion (Estimated): October 30, 2028
• Last Updated: April 13, 2026
• Results First Posted: February 21, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (3); IT (4); BE (5); HU (10); NZ (2); JO (6); BO (6); CN (26); JP (42); CZ (5); TW (5); BR (28); CR (4); DK (2); AU (2); US (77); DE (13); SL (3); KR (18); MY (5); CA (2); FR (11); PL (44); ES (7); IL (5); LI (2); TU (8)