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RECRUITING
NCT07577843
PHASE3

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

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 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

DRUG

JNJ-78934804

JNJ-78934804 will be administered subcutaneously.

DRUG

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

And 187 more locations on ClinicalTrials.gov