A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

— DUET-UC  

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 Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242484
• Other study ID #: CR109179
• Secondary ID: 78934804UCO20012
• Status: Recruiting
• Phase: Phase 2
• Start date: September 19, 2022
• Est. completion date: October 10, 2029

Study information

• Verified date: April 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 and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: October 10, 2029
• Est. primary completion date: May 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
• Moderately to severely active UC as assessed by the modified Mayo Score
• Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
• If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

• Has severe extensive colitis as defined in the protocol
• Extent of inflammatory disease limited to the rectum
• Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
• 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
• Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

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
Argentina	Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo	Ciudad Autonoma Buenos Aires
Argentina	CIPREC	Ciudad Autonoma de Buenos Aires
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autonoma de Buenos Aires
Argentina	Sanatorio Duarte Quiroz	Cordoba
Argentina	Centro de Investigaciones Medicas Mar Del Plata	Mar Del Plata
Argentina	Hospital Provincial del Centenario	Rosario
Australia	Box Hill Hospital	Box Hill
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	Monash Health, Monash Medical Centre	Clayton
Australia	Concord Hospital	Concord
Australia	Western Health	Footscray
Australia	Coastal Digestive Health	Maroochydore
Australia	Fiona Stanley Hospital	Murdoch
Australia	Royal Adelaide Hospital	North Terrace
Australia	Royal Melbourne Hospital	Parkville
Australia	The Alfred Hospital	Prahran
Austria	Universitaetsklinikum Salzburg - Landeskrankenhaus	Salzburg
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	Krankenhaus der Barmherzigen Brüder	Wien
Austria	Medizinische Universitat Wien	Wien
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	Algemeen Ziekenhuis Sint-Jan	Brugge
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	AZ Maria Middelares	Gent
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liege	Liege
Belgium	CHC MontLegia	Liège
Belgium	Vitaz	Sint-Niklaas
Brazil	Universidade Estadual Paulista 'Julio De Mesquita Filho'	Botucatu
Brazil	Chronos Clinica Medica LTDA - Chronos Pesquisa Clinica	Brasilia
Brazil	L2IP Instituto de Pesquisas Clinicas	Brasilia
Brazil	Fundacao Universidade de Caxias do Sul	Caxias Do Sul
Brazil	Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica	Curitiba
Brazil	Associacao Hospitalar Moinhos de Vento	Porto Alegre
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre
Brazil	Universidade Federal do Rio de Janeiro - Faculdade de Medicina	Rio de Janeiro
Brazil	SER - Servicos Especializados em Reumatologia da Bahia	Salvador
Brazil	Pesquisare Saude	Santo Andre
Brazil	Irmandade da Santa Casa da Misericórdia de Santos	Santos
Brazil	BR Trials	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	Medical Centre Hipocrat	Haskovo
Bulgaria	Diagnostic Consulting Center I Sliven	Sliven
Bulgaria	UMHAT 'Tsaritsa Yoanna'	Sofia
Bulgaria	University Hospital Alexandrovska - Clinic of Nephrology	Sofia-Grad
Bulgaria	Medical Center -Medika Plus	Veliko Tarnovo
Bulgaria	Multriprofile Hospital for Active Treatment Hristo Botev	Vratsa
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	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	London Health Sciences Centre - University Campus	London	Ontario
Canada	CMIIM, Centre médical L'Enjeu	Mont-Royal	Quebec
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	Columbia Gastroenterology	New Westminster	British Columbia
Canada	Hopital Chicoutimi	Saguenay
Canada	St. Jerome Medical Research	Saint-Jerome	Quebec
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	PerCuro Clinical Research Ltd.	Victoria	British Columbia
Canada	Health Sciences Centre	Winnipeg	Manitoba
Chile	Hospital Clinico Regional Dr. Guillermo Grant Benavente	Concepcion
Chile	Centro de Estudios Clínicos e Investigación Médica (CeCim)	Santiago
Chile	Clinica Dermacross S A	Santiago
Chile	Complejo Asistencial Hospital Dr. Sótero del Río	Santiago
China	China-Japan Friendship Hospital	Chaoyang
China	West China Hospital Sichuan University	Chengdu
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Jinhua municipal central hospital	Jinhua
China	Zhongda Hospital Southeast University	Nanjing
China	Union Hospital Tongji Medical College of Huazhong University of Science and Technology	Wuhan
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
Denmark	Aalborg Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Bispebjerg Og Frederiksberg Hospital	Copenhagen
Denmark	Herlev Hospital, University of Copenhagen	Herlev
Denmark	Odense Universitetshospital	Odense
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
France	CHU Amiens - Hopital Sud	AMIENS cedex 1
France	Hopital Louis Mourier	Colombes Cedex
France	Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor	Créteil
France	CHU Grenoble	Grenoble
France	Centre Hospitalier Départemental VENDEE	La Roche sur Yon
France	CHRU de Lille - Hopital Claude Huriez	Lille
France	Hopital Nord Marseille	Marseille
France	Hopital Saint Eloi	Montpellier
France	Clinique Ambroise Pare	Neuilly-sur-Seine
France	CHU de Nice Hopital de l Archet	Nice cedex 03
France	CHU Nimes Hopital Caremeau	Nîmes
France	Hopital Haut-Leveque, CMC Magellan	Pessac
France	Hospices Civils de Lyon HCL	Pierre Bénite
France	CHU Saint-etienne	Saint Etienne
France	Hopital de Rangueil	Toulouse cedex 09
France	CHRU Nancy-Brabois	Vandoeuvre-les-Nancy
Germany	Charite - Universitaetsmedizin Berlin (CCM)	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	University Hospital Dresden	Dresden
Germany	Universitaetsklinik Erlangen	Erlangen
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	BSF Studiengesellschaft	Halle
Germany	Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk	Halle (Saale)
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	Eugastro GmbH	Leipzig
Germany	Staedtisches Klinikum Lueneburg	Lueneburg
Germany	Universitaetsklinikum Mannheim	Mannheim
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Germany	Klinikum der Universitaet Muenchen	Munich
Germany	Praxis fur Innere Medizin und Gastroenterologie	Munster
Germany	MVZ Portal 10	Münster
Germany	Medius Klinik Nürtingen	Nürtingen
Germany	Siloah St Trudpert Klinikum	Pforzheim
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH	Saarbrücken
Germany	Universitaetsklinik Tuebingen	Tübingen
Germany	Universitatsklinikum Ulm	Ulm
Germany	Gemeinschaftspraxis Jakobeit	Wipperfürth
Germany	Universitatsklinikum Wurzburg	Würzburg
Greece	Alexandra General Hospital of Athens	Athens
Greece	Sotiria General State Hospital of Chest Diseases	Athens
Greece	Nikaia General Hospital	Piraievs
Greece	Hippokration Hospital	Thessaloniki
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft	Budapest
Hungary	Pannónia Magánorvosi Centrum Kft	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Bugat Pal Korhaz	Gyongyos
Hungary	Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp	Szeged
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
India	M S Ramaiah Medical College and Hospital	Bangalore
India	Siksha O Anusandhan University - Institute of Medical Scienc	Bhubaneswar
India	Apex Hospitals Ltd	Jaipur
India	All India Institute of Medical Sciences	New Delhi
India	Fortis Hospital	New Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	Yashoda Super Speciality Hospitals	Secunderabad
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 Medical Center Beilinson Campus	Petah Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv Yafo
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 HSR Istituto Scientifico Universitario San Raffaele	Milano
Italy	Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato	Monserrato
Italy	Azienda Ospedaliera San Gerardo	Monza
Italy	Ospedale Sacro Cuore Don Calabria	Negrar Di Valpolicella
Italy	Ospedale Villa Sofia-Cervello	Palermo
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Università Campus Biomedico di Roma	Roma
Italy	IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali	Rozzano
Italy	Casa Sollievo della Sofferenza	San Giovanni Rotondo
Japan	Asahikawa Medical University Hospital	Asahikawa
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-Ku
Japan	Fukuoka University Chikushi Hospital	Chikushino
Japan	Kitakyushu Municipal Medical Center	Fukuoka-ken
Japan	Gifu Prefectural General Medical Center	Gifu
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	Tokai University Hospital	Isehara
Japan	Kagoshima IBD Gastroenterology Clinic	Kagoshima
Japan	Kagoshima University Hospital	Kagoshima
Japan	Ofuna Chuo Hospital	Kamakura
Japan	Matsushima Clinic	Kanagawa
Japan	Nara Medical University Hospital	Kashihara
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa
Japan	Kobe University Hospital	Kobe
Japan	Yamanashi Prefectural Central Hospital	Kofu-Shi
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kurume University Hospital	Kurume
Japan	Kyoto University Hospital	Kyoto
Japan	University Hospital Kyoto Perfectural University of Medicine	Kyoto
Japan	Gunma University Hospital	Maebashi
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku
Japan	Kyorin University Hospital	Mitaka
Japan	Iwate Medical University Hospital	Morioka
Japan	Nagoya City University Hospital	Nagoya
Japan	Nagoya University Hospital	Nagoya
Japan	The Hospital of Hyogo College of Medicine	Nishinomiya
Japan	Ogaki Municipal Hospital	Ogaki
Japan	Oita Red Cross Hospital	Oita
Japan	Japan Community Health Care Organization Osaka Hospital	Osaka
Japan	Kinshukai Infusion Clinic	Osaka
Japan	Osaka City University Hospital	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka-shi
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 Tokushukai Hospital	Sapporo
Japan	Sapporo IBD Clinic	Sapporo Chuo-ku
Japan	Tokyo Metropolitan Bokutoh Hospital	Sumida-ku
Japan	National Hospital Organization Tokyo Medical Center	Tokyo
Japan	The Jikei University Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Tokyo Saiseikai Central Hospital	Tokyo
Japan	Oji General Hospital	Tomakomai
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Toyota Kosei Hospital	Toyota
Japan	Mie University Hospital	Tsu
Japan	University of Tsukuba Hospital	Tsukuba-City
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Yokohama City University Medical Center	Yokohama
Jordan	Istishari 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	Yeungnam University Hospital	Daegu
Korea, Republic of	Chosun university hospital	Gwangju
Korea, Republic of	The Catholic university of Korea, St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si
Korea, Republic of	Asan Medical Center	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
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju, Gangwon-do
Netherlands	Academisch Medisch Centrum Universiteit van Amsterdam	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	UMC Utrecht	Utrecht
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Hutt Hospital	Lower Hutt
New Zealand	Wellington Hospital	Wellington
Norway	Alesund sjukehus	Alesund
Norway	Vestre Viken HF Baerum Sykehus	Gjettum
Norway	Sykehuset Immlandet HF Gjøvik	Gjøvik
Norway	Akershus Universitetssykehus	Lørenskog
Norway	Oslo University Hospital HF Ulleval sykehus	Oslo
Norway	Universitetssykehuset Nord-Norge HF	Tromso
Poland	Szpital Uniwersytecki No2	Bydgoszcz
Poland	Centrum Medyczne Plejady	Krakow
Poland	Centrum Medyczne Promed	Krakow
Poland	AmiCare Centrum Medyczne	Lodz
Poland	ETG Lublin	Lublin
Poland	Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.	Lublin
Poland	Allmedica	Nowy Targ
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	Twoja Przychodnia - Szczecinskie Centrum Medyczne	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	EuroMediCare Szpital Specjalistyczny z Przychodnia	Wroclaw
Poland	Melita Medical Sp. z o.o.	Wroclaw
Poland	Przychodnia Vistamed	Wroclaw
Poland	ETG Zamosc	Zamosc
Portugal	Centro Hospitalar de Lisboa Norte Hospital Santa Maria	Lisboa
Portugal	Hospital Beatriz Angelo	Loures
Portugal	Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio	Portimao
Portugal	Centro Hospitalar de Entre o Douro e Vouga, E.P.E	Santa Maria da Feira
Portugal	Chvng - Unidade I	Vila Nova de Gaia
Slovakia	FNsP F.D.R. Banska Bystrica	Banska Bystrica
Slovakia	Cliniq s.r.o.	Bratislava
Slovakia	GASTRO I. s.r.o.	Presov
Slovakia	Gastroenterology Department ENDOMED, s.r.o.	Vranov nad Toplou
Slovenia	Splosna bolnisnica Celje	Celje
Slovenia	Univerzitetni klinicni center Ljubljana	Ljubljana
South Africa	Worthwhile Clinical Trials Lakeview Hospital	Benoni
South Africa	Groote Schur Hospital	Cape Town
South Africa	Mediclinic Panorama	Cape Town
South Africa	Practice Dr Naeem Moosa	Johannesburg
South Africa	Emmed Research	Pretoria
Spain	Hosp. Clinic de Barcelona	Barcelona
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
Spain	Hosp. Alvaro Cunqueiro	Vigo
Sweden	Karolinska Universitetssjukhuset Solna	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	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital, Division of Infectious Diseases	Taipei
Taiwan	Chang-Gung Memorial Hospital, LinKou Branch	Taoyuan
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Velocity Clinical Research	High Wycombe
United Kingdom	Chelsea And Westminster Hospital	London
United Kingdom	St George's University Hospital NHS Foundation Trust	London
United Kingdom	John Radcliffe Hospital	Oxford
United States	Valley Gastroenterology Medical Group	Arcadia	California
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Washington Gastroenterology, PLLC	Bellevue	Washington
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Onsite Clinical Solutions	Charlotte	North Carolina
United States	Tryon Medical Group	Charlotte	North Carolina
United States	Brigham & Women's Hospital	Chestnut Hill	Massachusetts
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Pioneer Research Solutions Inc.	Coconut Creek	Florida
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Southern California Research Center	Coronado	California
United States	Tri-State Gastroenterology Assoc	Crestview Hills	Kentucky
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Gastro One	Germantown	Tennessee
United States	Medical Research Center of Connecticut	Hamden	Connecticut
United States	GI Specialists of Houston	Houston	Texas
United States	Grand Teton Gastroenterology	Idaho Falls	Idaho
United States	IU Health University Hospital	Indianapolis	Indiana
United States	Etsu Quillen College Of Medicine	Johnson City	Tennessee
United States	Care Access Research, Kinston	Kinston	North Carolina
United States	Digestive and Liver Disease Institute	Kissimmee	Florida
United States	Osceola Regional Hospital	Kissimmee	Florida
United States	Florida Research Center Inc.	Lakewood Ranch	Florida
United States	Om Research LLC	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 Chandler Medical Center	Lexington	Kentucky
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Gastroenterolgy Associates of Central GA	Macon	Georgia
United States	Atlanta Gastroenterology Associates	Marietta	Georgia
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	University of Miami	Miami	Florida
United States	Medical College Of Wisconsin	Milwaukee	Wisconsin
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	New Haven	Connecticut
United States	Lenox Hill Hospital	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Omega Research Consultants	Orlando	Florida
United States	Medical College Of Virginia Hospital	Richmond	Virginia
United States	Digestive Disease Associates	Rock Hill	South Carolina
United States	Gastroenterology Consultants	Roswell	Georgia
United States	Synergy Clinical Research	Saint Petersburg	Florida
United States	Gastroenterology Clinic Of San Antonio P A	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Digestive Health Specialists	Tacoma	Washington
United States	GCP Clinical Research	Tampa	Florida
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Frontier Clinical Research	Uniontown	Pennsylvania
United States	Mohawk Valley Endoscopy Center	Utica	New York
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Jordan,  Korea, Republic of,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Slovakia,  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 based on the modified Mayo subscores.	Week 48
Secondary	Percentage of Participants with Endoscopic Improvement at Week 48	Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.	Week 48
Secondary	Percentage of Participants with Symptomatic Remission at Week 48	Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.	Week 48
Secondary	Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48	Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.	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 based on the modified Mayo subscores	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 concentration 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