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

Crohn's Disease Clinical Trial

— DUET-CD  

Official title:

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242471
• Other study ID #: CR109178
• Secondary ID: 2021-003314-3978
• Status: Recruiting
• Phase: Phase 2
• Start date: July 22, 2022
• Est. completion date: March 27, 2029

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 715
• Est. completion date: March 27, 2029
• Est. primary completion date: May 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
• Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
• Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
• If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

• Complications of CD that may be anticipated to require surgery
• Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
• Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
• Has a draining (example, functioning) stoma or ostomy
• Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
• Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Guselkumab
Guselkumab will be administered as subcutaneous injection.
• Golimumab
Golimumab will be administered as subcutaneous injection.
• JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.

Drug:
• Placebo
Placebo will be administered as subcutaneous injection.

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Adelaide
Australia	Box Hill Hospital	Box Hill
Australia	Monash Health, Monash Medical Centre	Clayton
Australia	Western Health	Footscray
Australia	St Vincent's hospital	Melbourne
Australia	Royal Prince Alfred Hospital	Newtown
Australia	Royal Adelaide Hospital	North Terrace
Australia	Royal Melbourne Hospital	Parkville
Austria	Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III	Salzburg
Austria	Akh Wien	Vienna
Austria	Klinikum Wels Grieskirchen	Wels
Austria	Akh Wien	Wien
Belgium	GZA Ziekenhuizen	Antwerpen
Belgium	Algemeen Ziekenhuis Sint-Jan	Brugge
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	AZ Maria Middelares	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liege	Liege
Belgium	CHC MontLegia	Liège
Belgium	Az Sint-Maarten	Mechelen
Belgium	Algemeen Ziekenhuis Delta	Roeselare
Belgium	Vitaz	Sint-Niklaas
Brazil	Hospital Das Clinicas Da Ufmg	Belo Horizonte - MG
Brazil	Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)	Botucatu
Brazil	Chronos Clinica Medica Ltda	Brasilia
Brazil	Impar Servicos Hospitalares S/A - Hospital Brasilia	Brasilia
Brazil	Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica	Curitiba
Brazil	Centro de Estudos Clínicos do Interior Paulista - CECIP	Jau
Brazil	Liga Norte Riograndense Contra O Cancer	Natal
Brazil	Associacao Hospitalar Moinhos de Vento	Porto Alegre
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul	Porto Alegre
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP	Ribeirao Preto
Brazil	Universidade Federal do Rio de Janeiro - Faculdade de Medicina	Rio de Janeiro
Brazil	Pesquisare Saude	Santo Andre
Brazil	Irmandade da Santa Casa da Misericórdia de Santos	Santos
Brazil	Kaiser Hospta	São José Do Rio Preto
Brazil	BR Trials	Sao Paulo
Brazil	CPQuali Pesquisa Clinica LTDA ME	Sao Paulo
Brazil	Hepatogastro	Sao Paulo
Brazil	Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE	Sao Paulo
Brazil	Instituto D Or de Pesquisa e Ensino (IDOR)	São Paulo
Bulgaria	MHAT Tzaritza Joanna	Sofia
Bulgaria	UMHAT 'Aleksandrovska' EAD	Sofia
Canada	Barrie GI Associates	Barrie	Ontario
Canada	Viable Clinical Research	Bridgewater
Canada	Foothills Hospital	Calgary	Alberta
Canada	Viable Clinical Research	Dartmouth	Nova Scotia
Canada	Covenant Health/Grey Nuns hospital	Edmonton	Alberta
Canada	Gastroenterology and Internal Medicine Research Institute (GIRI)	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	McGill University - Health Centre - Montreal General Hospital	Montreal	Quebec
Canada	Fraser Clinical Trials Inc.	New Westminster	British Columbia
Canada	Hopital Chicoutimi	Saguenay
Canada	St. Jerome Medical Research	Saint-Jerome	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Toronto Immune & Digestive Health Institute Inc.	Toronto	Ontario
Canada	GIRI Gastrointestinal Research Institute	Vancouver	British Columbia
Canada	The Gordon & Leslie Diamond Health Care Center	Vancouver	British Columbia
Canada	The Medical Arts Health Research Group	Vancouver	British Columbia
Canada	PerCuro Clinical Research Ltd.	Victoria	British Columbia
Canada	CMIIM, Centre médical L'Enjeu	Ville Mont-Royal	Quebec
Canada	Winnipeg Health Sciences Centre	Winnipeg	Manitoba
China	China Japan Friendship Hospital	Beijing
China	The second Xiangya Hospital of Central South University	Changsha
China	Changzhou No 2 Peoples Hospital	Changzhou City
China	West China Hospital Sichuan University	Chengdu
China	Chongqing Medical University	Chongqing
China	The First People's Hospital of Foshan	Foshan
China	Guangzhou First Municipal People's Hospital	Guangzhou
China	Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital	Guangzhou
China	Hainan General Hospital	Haikou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Jinhua municipal central hospital	Jinhua
China	The First Affiliated Hospital of NanChang University	Nanchang
China	Nanjing Drum Tower Hospital	Nanjing
China	Zhongda Hospital Southeast University	Nanjing
China	Ruijin Hospital Shanghai Jiao Tong University	Shanghai
China	Shanghai East Hospital	Shanghai
China	Renmin Hospital of Wuhan University	Wuhan
China	The Central Hospital of Wuhan	Wuhan
China	Wuhan Union Hospital	Wuhan
China	Wuxi People s Hospital	Wuxi
China	Zhongshan Hospital, Xiamen University	Xiamen
China	Yangzhou First People's Hospital	Yangzhou
China	ZhuZhou Central Hospital	ZhuZhou
Croatia	Opca bolnica Bjelovar	Bjelovar
Croatia	University Hospital Center Split	Split
Croatia	University Hospital Dubrava	Zagreb
Czechia	Vojenska nemocnice Brno	Brno
Czechia	ISCARE a.s.	Praha 9
Czechia	Detska klinika Masarykovy nemocnice v Usti nad Labem	Usti nad Labem
Denmark	Aarhus University Hospital	Aarhus
Denmark	Bispebjerg Og Frederiksberg Hospital	Copenhagen
Denmark	Herlev Hospital, University of Copenhagen	Herlev
Denmark	Odense Universitetshospital	Odense
Estonia	Tallinn Children's Hospital	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
France	CHU Amiens - Hopital Sud	AMIENS cedex 1
France	CHRU De Besancon	Besancon
France	Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor	Créteil
France	CHU Grenoble	Grenoble
France	Hopital Nord Marseille	Marseille
France	CHU de Nantes hotel Dieu	Nantes
France	Clinique Ambroise Pare	Neuilly-sur-Seine
France	CHU de Nice Hopital de l Archet	Nice
France	Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	CHRU Hopital de Pontchaillou	Rennes
France	Hôpital Yves Le Foll	Saint-Brieuc
France	Centre hospitalier universitaire de St Etienne	Saint-Etienne
France	CHU Rangueil	Toulouse
France	CHRU Nancy Brabois	Vandoeuvre les Nancy
Germany	Charite Campus Benjamin Franklin	Berlin
Germany	Charite Universitaetsmedizin Berlin - Campus Charite Mitte	Berlin
Germany	Krankenhaus Waldfriede Mitte	Berlin
Germany	Praxis Für Gastroenteroligie	Berlin
Germany	Gastroenterologische Spezialpraxis - Berlin-Karlshorst	Berlin-Karlshorst
Germany	Medizinisches Versorgungszentrum (MVZ) Dachau	Dachau
Germany	University Hospital Dresden	Dresden
Germany	MVZ Sanaklinikum Duisburg	Duisburg
Germany	Universitaetsklinik Erlangen	Erlangen
Germany	Universitaetsklinikum Essen	Essen
Germany	JWG-University Hospital	Frankfurt
Germany	Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus	Frankfurt/Main
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Klinikum Fulda - Tumorklinik - Germany	Fulda
Germany	Curiositas ad Sanum Studien und Beratungs GmBH	Haag
Germany	BSF Studiengesellschaft	Halle
Germany	Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk	Halle Saale
Germany	CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd	Heidelberg
Germany	University Hospital Heidelberg	Heidelberg
Germany	Universitatsklinikum Jena	Jena
Germany	Praxisgemeinschaft Jerichow	Jerichow
Germany	Gastroenterologie Opernstrasse	Kassel
Germany	Universitatsklinikum Schleswig Holstein Kiel	Kiel
Germany	Evangelisches Krankenhaus Kalk	Köln
Germany	Eugastro GmbH	Leipzig
Germany	Staedtisches Klinikum Lueneburg	Lueneburg
Germany	Medizinische Fakultät Mannheim der Universität Heidelberg	Mannheim
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Germany	Klinikum der Universitaet Muenchen	Munich
Germany	Universitatsklinikum Munster	Munster
Germany	MVZ Portal 10	Münster
Germany	Medius Klinik Nürtingen	Nürtingen
Germany	Universitaetsklinikum Regensburg	Regensburg
Germany	Universitaetsmedizin Rostock	Rostock
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH	Saarbrücken
Germany	Universitatsklinikum Tubingen	Tübingen
Germany	Universitatsklinikum Ulm	Ulm
Germany	Universitatsklinikum Wurzburg	Würzburg
Greece	General Hospital of Athens 'Ippokrateion'	Athens
Greece	Sotiria General State Hospital of Chest Diseases	Athens
Greece	Hippokration Hospital	Thessaloniki
Hungary	Obudai Egeszsegugyi Centrum Kft	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Semmelweis Egyetem I.Belgyogyaszati Klinika	Budapest
Hungary	Bugat Pal Korhaz	Gyongyos
Hungary	Szegedi Tudomanyegyetem	Szeged
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
India	ICON Hospital Orchid Medi services and Research Private Limited	Ahmedabad
India	M S Ramaiah Medical College and Hospital	Bengaluru
India	Siksha O Anusandhan University - Institute of Medical Scienc	Bhubaneswar
India	Srm Institutes For Medical Science (Sims)	Chennai
India	Fortis Memorial Research Institute	Gurugram
India	Asian Institute Of Gastroenterology	Hyderabad
India	Yashoda Super Speciality Hospitals	Hyderabad
India	P.D. Hinduja National Hospital and - Medical Research Center	Mumbai
India	All India Institute of Medical Sciences	New Delhi
India	Yashoda Super Speciality Hospitals	Secunderabad
India	Gujarat Gastro and Vascular Hospital	Surat
India	Surat Institute of Digestive Sciences Hospitals	Surat
Israel	Haemek Medical Center - Afula	Afula
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Hebrew University Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Med Ctr Beilinson Hosp	Petah Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Chaim Sheba Medical Center	Tel Hashomer
Israel	Assaf Harofeh Medical Center	Tzrifin
Italy	Università degli Studi di Bari	Bari
Italy	A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale	Catania
Italy	AOU Policlinico G.Martino	Messina
Italy	Ospedale San Raffaele	Milano
Italy	Ospedale Specializzato in Gastroenterologia Saverio de Bellis	Monopoli
Italy	Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato	Monserrato
Italy	Azienda Ospedaliera San Gerardo	Monza
Italy	Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar	Negrar ( Ve)
Italy	Ospedale Villa Sofia-Cervello	Palermo
Italy	Catholic University of Sacred Hearth	Roma
Italy	IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali	Rozzano
Italy	Ospedale Molinette, AO Città della Salute e della Scienza di	Torino
Japan	Asahikawa Medical University Hospital	Asahikawa
Japan	Tokyo Medical and Dental University Hospital	Bunkyo Ku
Japan	Fukuoka University Chikushi Hospital	Chikushino
Japan	Fukuoka University Hospital	Fukuoka-shi
Japan	Tokai University Hachioji Hospital	Hachioji
Japan	Hamamatsu University Hospital	Hamamatsu
Japan	Hirosaki University Hospital	Hirosaki
Japan	National Hospital Organization Hirosaki General Medical Center	Hirosaki
Japan	Hitachi General Hospital	Hitachi
Japan	Hospital of the University of Occupational and Environmental Health	Hukuoka
Japan	The Hospital of Hyogo College of Medicine	Hyogo
Japan	Kagoshima IBD Gastroenterology Clinic	Kagoshima
Japan	Kagoshima University Hospital	Kagoshima
Japan	Ofuna Chuo Hospital	Kamakura
Japan	Kanazawa University Hospital	Kanazawa
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa
Japan	Saitama Medical University Saitama Medical Center	Kawagoe
Japan	Kyushu Rosai Hospital	Kitakyushu
Japan	Kobe University Hospital	Kobe
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Kurume University Hospital	Kurume
Japan	University Hospital Kyoto Perfectural University of Medicine	Kyoto
Japan	Kyorin University Hospital	Mitaka
Japan	Iwate Medical University Hospital	Morioka
Japan	Nagaoka Red Cross Hospital	Nagaoka
Japan	Nagasaki University Hospital	Nagasaki
Japan	Nagoya University Hospital	Nagoya
Japan	Niigata University Medical And Dental Hospital	Niigata
Japan	Okayama University Hospital	Okayama-shi
Japan	Japan Community Health Care Organization Osaka Hospital	Osaka
Japan	Kinshukai Infusion Clinic	Osaka
Japan	Osaka City University Hospital	Osaka
Japan	Shiga University of Medical Science Hospital	Otsu
Japan	Saga University Hospital	Saga-shi
Japan	Tokitokai Tokito Clinic Coloproctology Center	Saitama
Japan	Toho University Sakura Medical Center	Sakura
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital	Sapporo
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo
Japan	Sapporo Medical University Hospital	Sapporo
Japan	Sapporo Tokushukai Hospital	Sapporo
Japan	Tohoku University Hospital	Sendai
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun
Japan	Jichi Medical University Hospital	Shimotsuke
Japan	Tokyo Women's Medical University Hospital	Shinjuku-Ku
Japan	Tokyo Metropolitan Bokutoh Hospital	Sumida ku
Japan	Takamatsu Red Cross Hospital	Takamatsu
Japan	Kitasato University Kitasato Institute Hospital	Tokyo
Japan	National Center for Global Health and Medicine	Tokyo
Japan	The Jikei University Hospital	Tokyo
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Ieda Hospital	Toyota
Japan	Mie University Hospital	Tsu
Japan	Yokohama City University Medical Center	Yokohama
Jordan	Abdali Hospital	Amman
Jordan	Jordan University Hospital	Amman
Jordan	Irbid Specialty Hospital	Irbid
Jordan	King Abdullah University Hospital	Irbid
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si
Korea, Republic of	Chosun university hospital	Gwangju
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St.Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St.Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Ampang	Ampang
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Netherlands	Academisch Medisch Centrum Universiteit van Amsterdam	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Erasmus MC	Rotterdam
Netherlands	UMC Utrecht	Utrecht
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Hutt Hospital	Lower Hutt
New Zealand	Wellington Hospital	Wellington
Norway	Alesund sjukehus	Alesund
Norway	Akershus Universitetssykehus	Lørenskog
Norway	Oslo University Hospital HF Ulleval sykehus	Oslo
Norway	Universitetssykehuset Nord-Norge HF	Tromso
Poland	Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Medyczne Plejady	Krakow
Poland	Centrum Medyczne Promed	Krakow
Poland	AmiCare Centrum Medyczne	Lodz
Poland	Gastromed ZOZ	Lublin
Poland	Wojewodzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Synexus Polska Sp. z o.o.	Poznan
Poland	Twoja Przychodnia	Poznan
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Endoskopia Sp z o.o.	Sopot
Poland	Sonomed Sp. z o.o.	Szczecin
Poland	GASTROMED Sp. z o.o.	Torun
Poland	Centralny Szpital Kliniczny Mswia	Warszawa
Poland	Centrum Zdrowia Matki, Dziecka i Mlodziezy	Warszawa
Poland	NZOZ Vivamed	Warszawa
Poland	Reumatika-Centrum Reumatologii, NZOZ	Warszawa
Poland	Wojskowy Instytut Medyczny	Warszawa
Poland	Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska	Wloclawek
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	Melita Medical Sp. z o.o.	Wroclaw
Poland	ETG Zamosc	Zamosc
Portugal	Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria	Lisboa
Portugal	Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio	Portimao
Portugal	Centro Hospitalar Vila Nova de Gaia	Porto
Portugal	Centro Hospitalar de Entre o Douro e Vouga, E.P.E	Santa Maria da Feira
Singapore	Gi Associates Gastroenterology	Singapore
Singapore	KL Ling Gastroenterology and Liver Clinic	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Slovenia	Splosna bolnisnica Celje	Celje
Slovenia	Univerzitetni klinicni center Ljubljana	Ljubljana
South Africa	Worthwhile Clinical Trials Lakeview Hospital	Benoni
South Africa	Clinical Research Centre University of Cape Town	Cape Town
South Africa	Groote Schur Hospital	Cape Town
South Africa	Inspired GI Care	Cape Town
South Africa	Mediclinic Panorama	Cape Town
South Africa	Hillcrest private	Durban
Spain	Hosp. Univ. La Paz	Madrid
Spain	Hosp. de Navarra	Pamplona
Spain	Hosp. Montecelo	Pontevedra
Spain	Corporacio Sanitari Parc Tauli	Sabadell
Spain	Hosp. Univ. Marques de Valdecilla	Santander
Spain	Hosp. Univ. de Torrejon	Torrejón de Ardoz
Sweden	Universitetssjukhuset Orebro	Orebro
Sweden	Karolinska University Hospital	Solna
Sweden	Ersta sjukhus	Stockholm
Switzerland	Universitatsspital Basel	Basel
Switzerland	Gastroenterologische Praxis Balsiger und Seibold	Bern
Switzerland	INSELSPITAL Universitatsspital Bern	Bern
Switzerland	Kantonsspital St Gallen	St. Gallen
Switzerland	UniversitaetsSpital Zuerich	Zuerich
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Velocity Clinical Research	High Wycombe
United Kingdom	St George's Healthcare NHS Trust	London
United Kingdom	Whipps Cross University Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	New Cross Hospital	Wolverhampton.
United States	Om Research LLC	Apple Valley	California
United States	Valley Gastroenterology Medical Group	Arcadia	California
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	University of Mississippi Medical Center	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Amel Med LLC Research	Austin	Texas
United States	Washington Gastroenterology, PLLC	Bellevue	Washington
United States	University of Alabama Liver Center	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Tryon Medical Group	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Brigham & Women's Hospital	Chestnut Hill	Massachusetts
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Pioneer Research Solutions Inc.	Coconut Creek	Florida
United States	Southern California Research Center	Coronado	California
United States	Tri-State Gastroenterology Assoc	Crestview Hills	Kentucky
United States	Baylor University Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Gastrointestinal Associates LLP	Flowood	Mississippi
United States	Saint Francis Hospital	Germantown	Tennessee
United States	Northwell Health	Great Neck	New York
United States	Medical Research Center of Connecticut	Hamden	Connecticut
United States	Susquehanna Gastroenterology Associates	Harrisburg	Pennsylvania
United States	Galen Medical Group	Hixson	Tennessee
United States	Homestead Associates in Research Inc	Homestead	Florida
United States	Accurate Clinical Research	Houston	Texas
United States	Marshall Health Clinical Research Center	Huntington	West Virginia
United States	IU Health University Hospital	Indianapolis	Indiana
United States	A1 Clinical Research	Jackson Heights	New York
United States	Etsu Quillen College Of Medicine	Johnson City	Tennessee
United States	Osceola Mental Health D/B/A Park Place Behavioral Health Care	Kissimmee	Florida
United States	Gastroenterology Clinic of Acadiana	Lafayette	Louisiana
United States	Florida Research Center Inc.	Lakewood Ranch	Florida
United States	Desert Gastroenterology Associates	Lancaster	California
United States	Care Access Las Vegas	Las Vegas	Nevada
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Dartmouth Hitchcock	Lebanon	New Hampshire
United States	University of Kentucky	Lexington	Kentucky
United States	Moore Clinical Trials, LLC	Little Rock	Arkansas
United States	Detroit Clinical Research Center	Livonia	Michigan
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Gastroenterolgy Associates of Central GA	Macon	Georgia
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	University of Miami Hospital	Miami	Florida
United States	Gastroenterology Group Of Naples	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Gastroenterology of Southern Indiana	New Albany	Indiana
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Omega Research Consultants	Orlando	Florida
United States	University of Pennsylvania - Perelman School of Medicine	Philadelphia	Pennsylvania
United States	The Oregon Clinic	Portland	Oregon
United States	Hunter Holmes McGuire Veterans Affairs Medical Center	Richmond	Virginia
United States	Digestive Disease Associates	Rock Hill	South Carolina
United States	Synergy Clinical Research	Saint Petersburg	Florida
United States	Care Access Research- Salt Lake City	Salt Lake City	Utah
United States	Gastroenterology Clinic Of San Antonio P A	San Antonio	Texas
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington Digestive Disease Center	Seattle	Washington
United States	Frontier Clinical Research	Smithfield	Pennsylvania
United States	FC Research, LLC	South Dartmouth	Massachusetts
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Digestive Health Specialists	Tacoma	Washington
United States	GCP Clinical Research	Tampa	Florida
United States	Cotton O'Neil Digestive Health Center	Topeka	Kansas
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	Digestive Health Specialists	Tyler	Texas
United States	Mohawk Valley Endoscopy Center	Utica	New York
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Northshore Gastroenterology Research, LLC	Westlake	Ohio
United States	Ascension via Christi Research	Wichita	Kansas
United States	Univ. of KS School of Med	Wichita	Kansas
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	Huron Gastroenterology Associates Center for Digestive Care	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Jordan,  Korea, Republic of,  Malaysia,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Singapore,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Clinical Remission at Week 48	Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).	Week 48
Primary	Percentage of Participants with Endoscopic Response at Week 48	Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 48
Secondary	Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48	Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.	Week 48
Secondary	Percentage of Participants with Endoscopic Remission at Week 48	Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD.	Week 48
Secondary	Percentage of Participants with Clinical Remission at Week 24	Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).	Week 24
Secondary	Percentage of Participants with Endoscopic Response at Week 24	Percentage of participants with endoscopic response at Week 24 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 24
Secondary	Percentage of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.	Up to Week 48
Secondary	Percentage of Participants with Serious Adverse Events (SAEs)	A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.	Up to Week 48
Secondary	Serum Concentrations of Guselkumab Over Time	Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.	Up to Week 48
Secondary	Serum Concentrations of Golimumab Over Time	Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.	Up to Week 48
Secondary	Percentage of Participants with Antibodies to Guselkumab	Percentage of participants with antibodies to guselkumab will be reported.	Up to Week 48
Secondary	Titers of Antibodies to Guselkumab	Titers of antibodies to guselkumab will be reported.	Up to Week 48
Secondary	Percentage of Participants with Antibodies to Golimumab	Percentage of participants with antibodies to golimumab will be reported.	Up to Week 48
Secondary	Titers of Antibodies to Golimumab	Titers of antibodies to golimumab will be reported.	Up to Week 48
Secondary	Percentage of Participants with Neutralizing Antibodies to Guselkumab.	Percentage of participants with neutralizing antibodies to guselkumab will be reported.	Up to Week 48
Secondary	Percentage of Participants with Neutralizing Antibodies to Golimumab	Percentage of participants with neutralizing antibodies to golimumab will be reported.	Up to Week 48