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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).
Official title: A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2026-05-22
Completion Date
2030-07-12
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Guselkumab
Guselkumab will be administered subcutaneously.
Locations (287)
Mayo Clinic
Scottsdale, Arizona, United States
GIA Sun City
Sun City, Arizona, United States
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
Endoscopic Research Inc
Orlando, 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
GIA Metairie
Metairie, Louisiana, United States
GIA Kansas City
Lee's Summit, Missouri, United States
New York Gastroenterology Associates
New York, New York, United States
GIA Rochester
Rochester, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 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
Michigan Center of Medical Research
Farmington Hill, Pennsylvania, United States
Palmetto Primary and Specialty Care Physicians, Charleston
Summerville, South Carolina, United States
Gastro One
Cordova, Tennessee, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
GIA Webster
Webster, Texas, United States
GIA Richmond
Richmond, Virginia, United States
GI Alliance Tacoma
Tacoma, Washington, United States
Sanatorio Duarte Quiroz
Córdoba, Argentina
GEDYT
Famailla, Argentina
Globalpsy
La Plata, Argentina
HIGEA
Mendoza, Argentina
Cer Instituto Medico
Quilmes, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
Banksia Trials SA
Adelaide, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Monash Medical Centre
Clayton, Australia
SA Gastrointestinal Services IBD SA
Kurraba Point, Australia
Macquarie University
Macquarie Island, Australia
Fiona Stanley Hospital
Murdoch, Australia
John Hunter Hospital
New Lambton, Australia
Mater Misericordiae Hospital
South Brisbane, Australia
The Melbourne Gut Clinic Epworth Hospital
West Melbourne, Australia
Kepler Universitatsklinikum GmbH
Linz, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, Austria
Klinikum Wels Grieskirchen
Wels, Austria
O L V Ziekenhuis
Aalst, Belgium
Cliniques Universitaires Saint Luc
Brussel (Bruxelles), Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Ghent University Hospital
Gent (Ghent), Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Algemeen Ziekenhuis Delta
Roeselare, Belgium
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília, Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, Brazil
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Jaú, Brazil
Galileo Medical Research Ltda
Juiz de Fora, Brazil
Cliged
Macaé, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Complexo Hospitalar de Niteroi
Niterói, 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
Clinica Ibis Medicina Ltda
Salvador, Brazil
Pesquisare Saude
Santo André, Brazil
BR Trials
São Paulo, Brazil
Solare Trials
São Paulo, Brazil
Rocco And Nazato Servicos Medicos Ltda
São Paulo, Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, Brazil
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
Nova Scotia Health Victoria General Site
Halifax, Nova Scotia, Canada
Viable Clinical Research
Kentville, Nova Scotia, Canada
London Digestive Disease Institute
London, Ontario, Canada
West GTA Research Inc
Mississauga, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
Toronto Digestive Disease Associates Inc
Vaughan, Ontario, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, Canada
Clinique IMD
Montreal, Quebec, Canada
Peking University Third Hospital
Beijing, China
The second Xiangya Hospital of Central South University
Changsha, China
Changzhou No 2 Peoples Hospital
Changzhou, China
West China Hospital Si Chuan University
Chengdu, China
Chongqing General Hospital
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Huai'an 1st Hospital
Huai'an, China
Lanzhou University Second Hospital
Lanzhou, China
Jiangsu Province Hospital
Nanjing, China
Ningbo medical center lihuili hospital
Ningbo, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The Central Hospital of Wuhan
Wuhan, China
Wuxi People s Hospital
Wuxi, China