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NCT07577843PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

5/22/2026

Completion Date

7/12/2030

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 Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \>= 220 but less than or equal to (\<=) 450 and either: a. Mean daily stool frequency (SF) count \>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>= 2.0, based on the unweighted CDAI component of abdominal pain (AP) * Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria * Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies Exclusion criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC * Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study * Presence of draining (that is, functioning) stoma or ostomy * Has a history of short bowel syndrome, is missing greater than (\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention * Currently has or is suspected of having an abscess

Interventions

DRUG

JNJ-78934804

DRUG

Guselkumab

Interested in This Trial?

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Conditions

Crohn Disease

Locations

Clinnova Research

Anaheim, California 92805

United States

Gastro SB Clinic

Chula Vista, California 91910

United States

United Medical Doctors

Los Alamitos, California 90720

United States

Medical Associates Research Group, Inc.

San Diego, California 92123

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Florida Research Center Inc.

Lakewood Rch, Florida 34211

United States

Sanchez Clinical Research, Inc

Miami, Florida 33157-6575

United States

GCP Clinical Research

Tampa, Florida 33609

United States

Atlanta Gastroenterology Specialists

Suwanee, Georgia 30024

United States

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky 41017

United States

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana 70503

United States

Michigan Center of Medical Research

Farmington Hills, Michigan 48334

United States

New York Gastroenterology Associates

New York, New York 10075

United States

University of North Carolina Hospital

Chapel Hill, North Carolina 27599

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma 73114

United States

The Oregon Clinic

Portland, Oregon 97220

United States

Gastro One

Cordova, Tennessee 38018

United States

Tyler Research Institute, LLC

Tyler, Texas 75701

United States

GI Alliance Tacoma

Tacoma, Washington 98405

United States

GEDYT

AAI, C1425BGC

Argentina

Globalpsy

La Plata, 1896

Argentina

HIGEA

Mendoza, M5500DPS

Argentina

Cer Instituto Medico

Quilmes, B1878DVB

Argentina

Banksia Trials SA

Adelaide, 5000

Australia

Royal Prince Alfred Hospital

Camperdown, 2050

Australia

Monash Medical Centre

Clayton, 3168

Australia

The Melbourne Gut Clinic Epworth Hospital

East Melbourne, 3002

Australia

IBD SA

Kurralta Park, 5037

Australia

John Hunter Hospital

New Lambton Heights, 2305

Australia

Mater Misericordiae Hospital

South Brisbane, 4101

Australia

Universitair Ziekenhuis Antwerpen

Edegem, 2650

Belgium

Ghent University Hospital

Ghent, 9000

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Algemeen Ziekenhuis Delta

Roeselare, 8800

Belgium

CDC - Centro Digestivo de Curitiba

Curitiba, 80430 180

Brazil

Cliged

Macaé, 27910-020

Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035 903

Brazil

Hospital Ernesto Dornelles

Porto Alegre, 90160 093

Brazil

Pesquisare Saude

Santo André, 09080-110

Brazil

BR Trials

São Paulo, 01236 030

Brazil

Rocco And Nazato Servicos Medicos Ltda

São Paulo, 04077-020

Brazil

INTEGRAL Pesquisa e Ensino

Votuporanga, 15500-269

Brazil

South Edmonton Gastroenterology Research Clinic

Edmonton, Alberta Code: T6K 4B2

Canada

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta T5R 1W2

Canada

GI Research Institute (G.I.R.I.)

Vancouver, British Columbia V6Z 2K5

Canada

Viable Clinical Research

Kentville, Nova Scotia B4N 0A3

Canada

London Digestive Disease Institute

London, Ontario N6K 1M6

Canada

West GTA Research Inc

Mississauga, Ontario L5M 2S4

Canada

Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario M6A 3B4

Canada

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec H2X 0C1

Canada

Clinique IMD

Montreal, Quebec H3H1E3

Canada

Peking University Third Hospital

Beijing, 100191

China

Changzhou No 2 Peoples Hospital

Changzhou, 213004

China

Chongqing General Hospital

Chongqing, 400014

China

Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

Guangzhou, 510655

China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310000

China

Huai'an 1st Hospital

Huai'an, 223300

China

Ningbo medical center lihuili hospital

Ningbo, 315041

China

ZhuZhou Central Hospital

Zhuzhou, 412007

China

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, 500 12

Czechia

Fakultni Thomayerova nemocnice

Prague, 14000

Czechia

ISCARE a.s.

Prague, 190 00

Czechia

CHU de Nantes hotel Dieu

Nantes, 44000

France

CHU de Reims

Reims, 51100

France

Krankenhaus Waldfriede Mitte

Berlin, 14163

Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105

Germany

Eugastro GmbH

Leipzig, 04103

Germany

Universitaetsklinikum Mannheim

Mannheim, 68167

Germany

Universitaetsmedizin Rostock

Rostock, 18057

Germany

Sushruta Multispecialty Hospital and Research Centre

Hubballi, 580021

India

Asian Institute Of Gastroenterology

Hyderabad, 500032

India

S. R. Kalla Memorial General Hospital

Jaipur, 302006

India

Lisie Hospital

Kochi, 682018

India

Yashoda Super Speciality Hospitals

Secunderabad, 500003

India

SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

Surat, 395002

India

Gujarat Gastro and Vascular Hospital

Surat, 395009

India

Assuta Medical center

Ashdod, 7747629

Israel

Bnai Zion Medical Center

Haifa, 31048

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Wolfson Medical Center

Holon, 5822012

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Meir Medical Center

Kfar Saba, 44281

Israel

Galilee Medical Center

Nahariya, 2210001

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

Hamamatsu University Hospital

Hamamatsu, 431-3192

Japan

National Hospital Organization Hirosaki National Hospital

Hirosaki, 036-8545

Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, 892-0843

Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871

Japan

Kobe University Hospital

Kobe, 650 0017

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520

Japan

Takano Hospital

Kumamoto, 862-0971

Japan

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642

Japan

Nagoya City University Hospital

Nagoya, 467-8602

Japan

National Hospital Organization Osaka National Hospital

Osaka, 540-0006

Japan

Japanese Red Cross Osaka Hospital

Osaka, 543-8555

Japan

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

Sapporo, 060-0033

Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033

Japan

National Hospital Organization Shizuoka Medical Center

Shimizu, 411-8611

Japan

Takamatsu Red Cross Hospital

Takamatsu, 760-0017

Japan

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506

Japan

Hospital Ampang

Ampang, 68000

Malaysia

Sultan Idris Shah Hospital

Kajang, 43000

Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, 88586

Malaysia

Hospital Sultanah Nur Zahirah

Kuala, 20400

Malaysia

University Malaya Medical Centre

Petaling Jaya, 50603

Malaysia

Radboud Umcn

Nijmegen, 6525 GA

Netherlands

Alesund sjukehus

Ålesund, 6017

Norway

Universitetssykehuset Nord-Norge HF

Tromsø, 9038

Norway

St. Olavs Hospital

Trondheim, 7030

Norway

Centrum Medyczne Medis ManerMed Sp Z O O

Bydgoszcz, 85 229

Poland

Centrum Medyczne Promed

Krakow, 31-513

Poland

Medrise Sp. z o.o.

Lublin, 20 582

Poland

Centrum Medyczne 'Medyk' Sp. z o.o. K.

Rzeszów, 35-055

Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434

Poland

ETG Zamosc

Zamość, 22 400

Poland

Uls Braga - Hosp. Braga

Braga, 4710 243

Portugal

Ulsam - Hosp. Santa Luzia

Viana do Castelo, 4900-408

Portugal

FNsP F. D. Roosevelta Banska Bystrica

Banská Bystrica, 975 17

Slovakia

Cliniq s.r.o.

Bratislava, 811 09

Slovakia

ENDOMED s.r.o

Košice, 040 13

Slovakia

KM Management spol. s r.o.

Nitra, 949 01

Slovakia

GASTRO I. s.r.o.

Prešov, 080 01

Slovakia

Gastro LM s.r.o.

Prešov, 080 01

Slovakia

Inje University Haeundae Paik Hospital

Busan, 48108

South Korea

The Catholic University of Korea Daejeon St Mary's Hospital

Daejeon, 34943

South Korea

Samsung Medical Center

Gangnam Gu, 06351

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Hosp. Univ. Infanta Leonor

Madrid, 28031

Spain

Hosp. Alvaro Cunqueiro

Vigo, 36312

Spain

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Antalya Training And Research Hospital

Antalya, 07100

Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, 34093

Turkey (Türkiye)

Marmara University Pendik Training Hospital

Istanbul, 34899

Turkey (Türkiye)

Izmir Sehir Hastanesi

Izmir, 35540

Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, 41001

Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, 33343

Turkey (Türkiye)