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NCT07577856PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

5/23/2026

Completion Date

10/16/2030

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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. * Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy * An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy * Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies Exclusion criteria: * Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD * Has a history of or ongoing chronic or recurrent infectious disease * Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab * Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention

Interventions

DRUG

JNJ-78934804

DRUG

Guselkumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Colitis, Ulcerative

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

GIA Metairie

Metairie, Louisiana 70006

United States

Michigan Center of Medical Research

Farmington Hills, Michigan 48334

United States

GIA Kansas City

Lee's Summit, Missouri 64086

United States

New York Gastroenterology Associates

New York, New York 10075

United States

University of North Carolina Hospital

Chapel Hill, North Carolina 27599-7080

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

Frontier Clinical Research

Uniontown, Pennsylvania 15401

United States

Gastro One

Cordova, Tennessee 38018

United States

Southern Star Research Institute, LLC

San Antonio, Texas 78229

United States

Tyler Research Institute, LLC

Tyler, Texas 75701

United States

GI Alliance Tacoma

Tacoma, Washington 98405

United States

GEDYT

AAI, C1425BGC

Argentina

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, B1643CRO

Argentina

Globalpsy

La Plata, 1896

Argentina

HIGEA

Mendoza, M5500DPS

Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, B1878GEG

Argentina

Hospital Provincial del Centenario

Rosario, S2000KDS

Argentina

MR Medicina Reumatologica

San Fernando, B1646

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

SA Gastrointestinal Services

Kurralta Park, 5037

Australia

Macquarie University

Macquarie University, 2109

Australia

Fiona Stanley Hospital

Murdoch, 6150

Australia

John Hunter Hospital

New Lambton Heights, 2305

Australia

Mater Misericordiae Hospital

South Brisbane, 4101

Australia

Kepler Universitatsklinikum GmbH

Linz, 4021

Austria

Krankenhaus der Barmherzigen Brüder

Vienna, 1020

Austria

Klinikum Wels Grieskirchen

Wels, 4600

Austria

Imelda Bonheiden

Bonheiden, 2820

Belgium

AZ Sint-Lucas

Bruges, 8310

Belgium

ULB Erasme Ziekenhuis

Brussels, 1070

Belgium

UZ Brussel

Brussels, 1090

Belgium

Cliniques Universitaires Saint Luc

Brussels, 1200

Belgium

AZ Maria Middelares

Ghent, 9000

Belgium

Ghent University Hospital

Ghent, 9000

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

CHC MontLegia

Liège, 4000

Belgium

CDC - Centro Digestivo de Curitiba

Curitiba, 80430 180

Brazil

CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda

Jaú, 17206-607

Brazil

Complexo Hospitalar de Niteroi

Niterói, 24020-096

Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035-903

Brazil

Hospital Ernesto Dornelles

Porto Alegre, 90160-092

Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

Ribeirão Preto, 14051140

Brazil

Pesquisare Saude

Santo André, 09080-110

Brazil

BR Trials

São Paulo, 01236 030

Brazil

Solare Trials

São Paulo, 01307 002

Brazil

Rocco And Nazato Servicos Medicos Ltda

São Paulo, 04077-020

Brazil

INTEGRAL Pesquisa e Ensino

Votuporanga, 15500-269

Brazil

MHAT Sv. Karidad EAD

Plovdiv, 4004

Bulgaria

Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

Sofia, 1407

Bulgaria

Diagnostic Consultative Center Neoclinic EAD

Sofia, 1408

Bulgaria

St Ivan Rilski University Multiprofile Hospital For Active Treatment

Sofia, 1431

Bulgaria

DCC Convex EOOD

Sofia, 1680

Bulgaria

Acibadem City Clinic - Oncology Center

Sofia, 1784

Bulgaria

Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

Varna, 9010

Bulgaria

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

Barrie GI Associates

Barrie, Ontario L4M 7G1

Canada

Charlton Digestive Disease Centre

Hamilton, Ontario L8N1Y2

Canada

London Digestive Disease Institute

London, Ontario N6K 1M6

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

China Japan Friendship Hospital

Beijing, 100013

China

Beijing Friendship Hospital Capital Medical University

Beijing, 100050

China

Peking University Third Hospital

Beijing, 100191

China

Changzhou No 2 Peoples Hospital

Changzhou, 213000

China

Chongqing General Hospital

Chongqing, 400014

China

The First People's Hospital of Foshan

Foshan, 528010

China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080

China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260

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, 310016

China

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022

China

Huai'an 1st Hospital

Huai'an, 223300

China

Jinhua municipal central hospital

Jinhua, 321013

China

Lanzhou University Second Hospital

Lanzhou, 730030

China

Ningbo medical center lihuili hospital

Ningbo, 315000

China

The Second Hospital of Hebei Medical University

Shijiazhuang, 050000

China

Taihe Hospital

Shiyan, 442000

China

Second Affiliated Hospital, SooChow University

Suzhou, 215004

China

Zhongshan Hospital, Xiamen University

Xiamen, 361004

China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, 450014

China

ZhuZhou Central Hospital

Zhuzhou, 412007

China

Affiliated Hospital of Zunyi Medical University

Zunyi, 563099

China

Nemocnice Ceske Budejovice a s

České Budějovice, 37001

Czechia

Gastroenterologie, s.r.o., Hradec Kralove

Hradec Kralova, 500 02

Czechia

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, 500 12

Czechia

Oblastni nemocnice Kladno a.s.

Kladno, 27259

Czechia

Fakultni Nemocnice Ostrava

Ostrava, 70852

Czechia

Fakultni Thomayerova nemocnice

Prague, 14000

Czechia

ISCARE a.s.

Prague, 190 00

Czechia

Herlev Hospital

Herlev, 2730

Denmark

Hvidovre Hospital

Hvidovre, 2650

Denmark

Odense University Hospital

Odense, 5000

Denmark

CHU Amiens

Amiens, 80000

France

Hopital Jean Minjoz

Besançon, 25000

France

Hopital Beaujon

Clichy, 92110

France

Hopital de Bicetre

Le Kremlin-Bicêtre, 94270

France

CHU de Lille Hopital Claude Huriez

Lille, 59037

France

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34090

France

CHU de Nantes hotel Dieu

Nantes, 44000

France

CHU de Nice Hopital de l Archet 2

Nice, 06202

France

Hopital Haut Leveque CHU de Bordeaux

Pessac, 33600

France

CHU de Reims

Reims, 51100

France

CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, 42270

France

CHU Toulouse

Toulouse, 31059

France

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54500

France

Praxis Fur Gastroenteroligie

Berlin, 10825

Germany

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 12203

Germany

Krankenhaus Waldfriede Mitte

Berlin, 14163

Germany

Medizinisches Versorgungszentrum (MVZ) Dachau

Dachau, 85221

Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Universitaetsklinik Erlangen

Erlangen, 91054

Germany

Studiengesellschaft Mitteldeutschland GmbH

Halle, 06108

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Universitatsklinikum Jena

Jena, 07747

Germany

Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Karlshorst, 10318

Germany

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105

Germany

Eugastro GmbH

Leipzig, 04103

Germany

Universitaetsklinikum Mannheim

Mannheim, 68167

Germany

Klinik und Poliklinik für Innere Medizin II Klinikum rechts an der Isar der TU Muenchen

München, 81675

Germany

Universitaetsmedizin Rostock

Rostock, 18057

Germany

General Hospital of Athens Evaggelismos

Athens, 115 21

Greece

General Hospital Of Athens Korgialenio Benakio H R C

Athens, 11526

Greece

Thoracic General Hospital Of Athens I Sotiria

Athens, 11527

Greece

Geniko Nosokomeio Peiraia Tzaneio

Piraeus, 18536

Greece

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036

Hungary

Semmelweis Egyetem 1

Budapest, 1082

Hungary

Semmelweis Egyetem

Budapest, 1082

Hungary

Semmelweis Egyetem 2

Budapest, 1083

Hungary

Pannónia Magánorvosi Centrum Kft

Budapest, H-1136

Hungary

Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6725

Hungary

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

P D Hinduja National Hospital and Medical Research Center

Mumbai, 400016

India

Yashoda Super Speciality Hospitals

Secunderabad, 500003

India

SIDS Hospital & Research Centre

Surat, 395002

India

Gujarat Gastro and Vascular Hospital

Surat, 395009

India

Assuta Medical center

Ashdod, 7747629

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Bnai Zion Medical Center

Haifa, 60910

Israel

Wolfson Medical Center

Holon, 5822012

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Meir Medical Center

Kfar Saba, 4428164

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

Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

Milan, 20122

Italy

Ospedale San Raffaele di Milano

Milan, 20132

Italy

Ospedale Sacro Cuore Negrar-Verona

Negrar Verona, 37024

Italy

Azienda Ospedaliera San Camillo-Forlanini

Roma, 00152

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Fatebenefratelli Isola Tiberina - Gemelli Isola

Roma, 00186

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Institute of Science Tokyo Hospital

Bunkyō City, 113 8519

Japan

Hamamatsu University Hospital

Hamamatsu, 431-3192

Japan

Matsuda Hospital

Hamamatsu, 432-8061

Japan

National Hospital Organization Mito Medical Center

Higashi-Ibaraki, 311-3193

Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, 892-0843

Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Takano Hospital

Kumamoto, 862-0971

Japan

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642

Japan

Kyorin University Hospital

Mitaka, 181-8611

Japan

Aichi Medical University Hospital

Nagakute, 480-1195

Japan

Hyogo Medical University Hospital

Nishinomiya Shi, 663 8501

Japan

National Hospital Organization Osaka National Hospital

Osaka, 540-0006

Japan

Osaka Metropolitan University Hospital

Osaka, 545-8585

Japan

Oita Red Cross Hospital

Ōita, 870-0033

Japan

Saga University Hospital

Saga, 849-8501

Japan

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

Sapporo, 060-0033

Japan

Sapporo Medical University Hospital

Sapporo, 060-8543

Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033

Japan

National Hospital Organization Shizuoka Medical Center

Shimizu, 411-8611

Japan

Center Hospital of the National Center for Global Health and Medicine

Shinjuku Ku, 162 8655

Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida Ku, 130 8575

Japan

The Jikei University Hospital

Tokyo, 105-8471

Japan

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506

Japan

Hospital Ampang

Ampang, 68000

Malaysia

Sultan Idris Shah Hospital

Kajang, 43000

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Hospital Sultanah Nur Zahirah

Kuala Terengganu, 20400

Malaysia

Vrije Universiteit Medisch Centrum

Amsterdam, 1081 HV

Netherlands

Radboud Umcn

Nijmegen, 6525 GA

Netherlands

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC

Netherlands

UMC Utrecht

Utrecht, 3584 CX

Netherlands

Alesund sjukehus

Ålesund, 6017

Norway

Sykehuset Innlandet HF Gjøvik

Gjøvik, 2819

Norway

Akershus Universitetssykehus

Lorenskog, 1474

Norway

Sykehuset Ostfold

Moss, 1535

Norway

Universitetssykehuset Nord-Norge HF

Tromsø, 9019

Norway

St. Olavs Hospital

Trondheim, 7030

Norway

Centrum Medyczne Medis ManerMed Sp Z O O

Bydgoszcz, 85 229

Poland

Centrum Medyczne Plejady

Krakow, 30 363

Poland

Centrum Medyczne Promed

Krakow, 31-513

Poland

Medrise Sp. z o.o.

Lublin, 20 582

Poland

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-090

Poland

Medicus Zaniewski i Bilski

Olsztyn, 10-684

Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, 45-819

Poland

Centrum Medyczne Medyk

Rzeszów, 35-326

Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434

Poland

Sonomed Sp. z o.o.

Szczecin, 71-685

Poland

GASTROMED Sp. z o.o.

Torun, 87 100

Poland

H-T Centrum Medyczne

Tychy, 43 100

Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04 501

Poland

Centrum Medyczne Oporow

Wroclaw, 52 416

Poland

EMC Instytut Medyczny S A Penta Hospitals Przychodnie

Wroclaw, 54-239

Poland

ETG Zamosc

Zamość, 22 400

Poland

Uls Braga - Hosp. Braga

Braga, 4710 243

Portugal

Hosp. Da Luz Lisboa

Lisbon, 1500 650

Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, 1649 028

Portugal

Uls Algarve Hosp Portimao

Portimão, 8500 338

Portugal

Uls Arrabida - Hosp. Sao Bernardo

Setúbal, 2910 549

Portugal

Baneasa Tumor Center Hospital

Bucharest, 013685

Romania

Spitalul Clinic Colentina

Bucharest, 020125

Romania

Institutul Clinic Fundeni

Bucharest, 022328

Romania

Gastro Med S R L

Cluj-Napoca, 400380

Romania

Oncohelp Medical Center

Timișoara, 300239

Romania

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

Ustredna Vojenska Nemocnica SNP Ruzomberok- Fakultna Nemocnica

Ružomberok, 03401

Slovakia

Korea University Ansan Hospital

Ansan-si, 15355

South Korea

Inje University Haeundae Paik Hospital

Busan, 48108

South Korea

The Catholic University of Korea Daejeon St Mary's Hospital

Daejeon, 34943

South Korea

Kyung Hee University Hospital

Dongdaemun-gu, 02447

South Korea

Samsung Medical Center

Gangnam Gu, 06351

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010

Spain

Hosp. Univ. Infanta Leonor

Madrid, 28031

Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Virgen Macarena

Seville, 41009

Spain

Hosp. Alvaro Cunqueiro

Vigo, 36312

Spain

Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern

Bern, 3001

Switzerland

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Mackay Memorial Hospital

Taipei, 10449

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Antalya Training And Research Hospital

Antalya, 07100

Turkey (Türkiye)

Sanko Universitesi Hastanesi

Gaziantep, 27090

Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, 34093

Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098

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)

Addenbrookes Hospital

Cambridge, CB2 0QQ

United Kingdom

Cardiff and Vale UHB - University Hospital of Wales

Cardiff, CF14 4XW

United Kingdom

Ninewells Hospital

Dundee, DD2 1GZ

United Kingdom

Whipps Cross University Hospital

Leytonstone, E11 1NR

United Kingdom

Kings College Hospital

London, SE5 9RS

United Kingdom

St Georges Healthcare NHS Trust

London, SW17 0QT

United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP

United Kingdom