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RECRUITING
NCT07577856
PHASE3

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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: 78934804UCO3001: 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 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

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

JNJ-78934804

JNJ-78934804 will be administered subcutaneously.

DRUG

Guselkumab

Guselkumab will be administered subcutaneously.

Locations (318)

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

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

Frontier Clinical Research

Uniontown, Pennsylvania, United States

Palmetto Primary and Specialty Care Physicians, Charleston

Summerville, South Carolina, 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

GIA Webster

Webster, Texas, United States

GIA Richmond

Richmond, Virginia, United States

GI Alliance Tacoma

Tacoma, Washington, United States

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, Argentina

GEDYT

Famailla, Argentina

Globalpsy

La Plata, Argentina

HIGEA

Mendoza, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

MR Medicina Reumatologica

San Fernando, Argentina

Banksia Trials SA

Adelaide, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

Monash Medical Centre

Clayton, Australia

SA Gastrointestinal Services

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

Imelda Bonheiden

Bonheiden, Belgium

AZ Sint-Lucas

Brugge (Bruges), Belgium

UZ Brussel

Brussel (Bruxelles), Belgium

Cliniques Universitaires Saint Luc

Brussel (Bruxelles), Belgium

AZ Maria Middelares

Gent (Ghent), Belgium

Ghent University Hospital

Gent (Ghent), Belgium

ULB Erasme Ziekenhuis

Koekelberg/Brussel (Bruxelles), Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

CHC MontLegia

Liège, Belgium

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, Brazil

CDC - Centro Digestivo de Curitiba

Curitiba, Brazil

CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda

Jaú, 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

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

MHAT Sv. Karidad EAD

Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

Sofia, Bulgaria

Diagnostic Consultative Center Neoclinic EAD

Sofia, Bulgaria

St Ivan Rilski University Multiprofile Hospital For Active Treatment

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment - Tsaritsa Yoanna - ISUL, EAD

Sofia, Bulgaria

DCC Convex EOOD

Sofia, Bulgaria

Acibadem City Clinic - Oncology Center

Sofia, Bulgaria

Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

Varna, 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

China Japan Friendship Hospital

Beijing, China

Beijing Friendship Hospital Capital Medical University

Beijing, China

Peking University Third Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, 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

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, China

And 218 more locations on ClinicalTrials.gov