RecruitingPhase 3NCT07577843

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

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


Sponsor

Janssen Research & Development, LLC

Enrollment

460 participants

Start Date

May 22, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Guselkumab and a drug called JNJ-78934804 for people with crohn disease. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGJNJ-78934804

JNJ-78934804 will be administered subcutaneously.

DRUGGuselkumab

Guselkumab will be administered subcutaneously.


Locations(142)

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

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

Gastro One

Cordova, Tennessee, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

GI Alliance Tacoma

Tacoma, Washington, United States

GEDYT

AAI, Argentina

Globalpsy

La Plata, Argentina

HIGEA

Mendoza, Argentina

Cer Instituto Medico

Quilmes, 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

IBD SA

Kurralta Park, Australia

John Hunter Hospital

New Lambton Heights, Australia

Mater Misericordiae Hospital

South Brisbane, Australia

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Ghent University Hospital

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

CDC - Centro Digestivo de Curitiba

Curitiba, Brazil

Cliged

Macaé, Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, Brazil

Hospital Ernesto Dornelles

Porto Alegre, 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

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

London Digestive Disease Institute

London, Ontario, Canada

West GTA Research Inc

Mississauga, 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

Peking University Third Hospital

Beijing, China

Changzhou No 2 Peoples Hospital

Changzhou, China

Chongqing General Hospital

Chongqing, 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

Huai'an 1st Hospital

Huai'an, China

Ningbo medical center lihuili hospital

Ningbo, China

ZhuZhou Central Hospital

Zhuzhou, China

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, Czechia

Fakultni Thomayerova nemocnice

Prague, Czechia

ISCARE a.s.

Prague, Czechia

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 (Surat Institute of Digestive Sciences) Hospital and Research Centre

Surat, India

Gujarat Gastro and Vascular Hospital

Surat, India

Assuta Medical center

Ashdod, Israel

Bnai Zion Medical Center

Haifa, Israel

Rambam 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

National Hospital Organization Hirosaki National Hospital

Hirosaki, Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa, Japan

Kobe University Hospital

Kobe, Japan

Kumamoto University Hospital

Kumamoto, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan

Takano Hospital

Kumamoto, Japan

Kitasato University Kitasato Institute Hospital

Minatoku, Japan

Nagoya City University Hospital

Nagoya, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Japanese Red Cross Osaka Hospital

Osaka, 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

Takamatsu Red Cross Hospital

Takamatsu, Japan

Yamanashi Prefectural Central Hospital

Yamanashi, Japan

Hospital Ampang

Ampang, Malaysia

Sultan Idris Shah Hospital

Kajang, Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia

Hospital Sultanah Nur Zahirah

Kuala, Malaysia

University Malaya Medical Centre

Petaling Jaya, Malaysia

Radboud Umcn

Nijmegen, Netherlands

Alesund sjukehus

Ålesund, 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' Sp. z o.o. K.

Rzeszów, Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland

ETG Zamosc

Zamość, Poland

Uls Braga - Hosp. Braga

Braga, Portugal

Ulsam - Hosp. Santa Luzia

Viana do Castelo, 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

Asan Medical Center

Seoul, South Korea

Hosp. Univ. Infanta Leonor

Madrid, Spain

Hosp. Alvaro Cunqueiro

Vigo, Spain

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Antalya Training And Research Hospital

Antalya, Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, Turkey (Türkiye)

Marmara University Pendik Training Hospital

Istanbul, Turkey (Türkiye)

Izmir Sehir Hastanesi

Izmir, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07577843


Related Trials