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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
Official title: A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
644
Start Date
2026-05-23
Completion Date
2030-10-16
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Guselkumab
Guselkumab will be administered subcutaneously.
Locations (170)
Clinnova Research
Anaheim, California, United States
Gastro SB Clinic
Chula Vista, California, United States
United Medical Doctors
Los Alamitos, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Florida Research Center Inc.
Lakewood Rch, Florida, United States
Sanchez Clinical Research, Inc
Miami, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Atlanta Gastroenterology Specialists
Suwanee, Georgia, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
New York Gastroenterology Associates
New York, New York, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
Gastro One
Cordova, Tennessee, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
GI Alliance Tacoma
Tacoma, Washington, United States
GEDYT
AAI, Argentina
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, Argentina
Globalpsy
La Plata, Argentina
HIGEA
Mendoza, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina
MR Medicina Reumatologica
San Fernando, Argentina
Banksia Trials SA
Adelaide, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Monash Medical Centre
Clayton, Australia
The Melbourne Gut Clinic Epworth Hospital
East Melbourne, Australia
SA Gastrointestinal Services
Kurralta Park, Australia
Fiona Stanley Hospital
Murdoch, Australia
John Hunter Hospital
New Lambton Heights, Australia
Mater Misericordiae Hospital
South Brisbane, Australia
Imelda Bonheiden
Bonheiden, Belgium
AZ Sint-Lucas
Bruges, Belgium
ULB Erasme Ziekenhuis
Brussels, Belgium
UZ Brussel
Brussels, Belgium
AZ Maria Middelares
Ghent, Belgium
Ghent University Hospital
Ghent, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
CDC - Centro Digestivo de Curitiba
Curitiba, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, Brazil
Pesquisare Saude
Santo André, Brazil
BR Trials
São Paulo, Brazil
Rocco And Nazato Servicos Medicos Ltda
São Paulo, Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, Brazil
MHAT Sv. Karidad EAD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
Sofia, Bulgaria
Diagnostic Consultative Center Neoclinic EAD
Sofia, Bulgaria
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, Canada
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, Canada
Viable Clinical Research
Kentville, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
Charlton Digestive Disease Centre
Hamilton, Ontario, Canada
London Digestive Disease Institute
London, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, Canada
Clinique IMD
Montreal, Quebec, Canada
Beijing Friendship Hospital Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
Changzhou No 2 Peoples Hospital
Changzhou, China
Chongqing General Hospital
Chongqing, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou, China
Huai'an 1st Hospital
Huai'an, China
Ningbo medical center lihuili hospital
Ningbo, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
ZhuZhou Central Hospital
Zhuzhou, China
Nemocnice Ceske Budejovice a s
České Budějovice, Czechia
Gastroenterologie, s.r.o., Hradec Kralove
Hradec Kralova, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
Fakultni Thomayerova nemocnice
Prague, Czechia
ISCARE a.s.
Prague, Czechia
Herlev Hospital
Herlev, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
CHU de Lille Hopital Claude Huriez
Lille, France
CHU de Nantes hotel Dieu
Nantes, France
CHU de Reims
Reims, France
Krankenhaus Waldfriede Mitte
Berlin, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, Germany
Eugastro GmbH
Leipzig, Germany
Universitaetsklinikum Mannheim
Mannheim, Germany
Universitaetsmedizin Rostock
Rostock, Germany
Sushruta Multispecialty Hospital and Research Centre
Hubballi, India
Asian Institute Of Gastroenterology
Hyderabad, India
S. R. Kalla Memorial General Hospital
Jaipur, India
Lisie Hospital
Kochi, India
Yashoda Super Speciality Hospitals
Secunderabad, India
SIDS Hospital & Research Centre
Surat, India
Gujarat Gastro and Vascular Hospital
Surat, India
Assuta Medical center
Ashdod, Israel
Rambam Medical Center
Haifa, Israel
Bnai Zion Medical Center
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Galilee Medical Center
Nahariya, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Hamamatsu University Hospital
Hamamatsu, Japan
Matsuda Hospital
Hamamatsu, Japan
National Hospital Organization Mito Medical Center
Higashi-Ibaraki, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, Japan
Kumamoto University Hospital
Kumamoto, Japan
Takano Hospital
Kumamoto, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, Japan
Aichi Medical University Hospital
Nagakute, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Oita Red Cross Hospital
Ōita, Japan
Saga University Hospital
Saga, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Japan
National Hospital Organization Shizuoka Medical Center
Shimizu, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku Ku, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, Japan
Hospital Ampang
Ampang, Malaysia
Sultan Idris Shah Hospital
Kajang, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Malaysia
Radboud Umcn
Nijmegen, Netherlands
Alesund sjukehus
Ålesund, Norway
Sykehuset Innlandet HF Gjøvik
Gjøvik, Norway
Universitetssykehuset Nord-Norge HF
Tromsø, Norway
St. Olavs Hospital
Trondheim, Norway
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, Poland
Centrum Medyczne Promed
Krakow, Poland
Medrise Sp. z o.o.
Lublin, Poland
Centrum Medyczne Medyk
Rzeszów, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland
Sonomed Sp. z o.o.
Szczecin, Poland
EMC Instytut Medyczny S A Penta Hospitals Przychodnie
Wroclaw, Poland
ETG Zamosc
Zamość, Poland
Uls Braga - Hosp. Braga
Braga, Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal
FNsP F. D. Roosevelta Banska Bystrica
Banská Bystrica, Slovakia
Cliniq s.r.o.
Bratislava, Slovakia
ENDOMED s.r.o
Košice, Slovakia
KM Management spol. s r.o.
Nitra, Slovakia
GASTRO I. s.r.o.
Prešov, Slovakia
Gastro LM s.r.o.
Prešov, Slovakia
Inje University Haeundae Paik Hospital
Busan, South Korea
The Catholic University of Korea Daejeon St Mary's Hospital
Daejeon, South Korea
Samsung Medical Center
Gangnam Gu, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hosp. Gral. Univ. Dr. Balmis
Alicante, Spain
Hosp. Univ. Infanta Leonor
Madrid, Spain
Taipei Mackay Memorial Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Antalya Training And Research Hospital
Antalya, Turkey (Türkiye)
Sanko Universitesi Hastanesi
Gaziantep, Turkey (Türkiye)
Bezmialem University Medical Faculty
Istanbul, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Izmir Sehir Hastanesi
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, Turkey (Türkiye)
Kings College Hospital
London, United Kingdom
St Georges Healthcare NHS Trust
London, United Kingdom