AzTrials
AzTrials

Colitis, UlcerativePhase 3DUET ENCORE-UCNCT07577856

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

A Phase 3 study testing JNJ-78934804 and Guselkumab in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 318 sites in 33 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis, Ulcerative
What is being tested?
JNJ-78934804 and Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
644 participants
Where
318 sitesin 33 countries
Study dates
23 May 2026to 16 Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

318 sites in 33 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

318 sites in 33 countries

United States30 sites, 30 recruiting

  • Clinnova Research

    Anaheim, California, 92805

    Recruiting

  • University of North Carolina Hospital

    Chapel Hill, North Carolina, 27599-7080

    Recruiting

  • Gastro SB Clinic

    Chula Vista, California, 91910

    Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

    Recruiting

  • Gastro One

    Cordova, Tennessee, 38018

    Recruiting

  • Tri-State Gastroenterology Assoc

    Crestview Hills, Kentucky, 41017

    Recruiting

  • Michigan Center of Medical Research

    Farmington Hill, Pennsylvania, 48334

    Recruiting

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana, 70503

    Recruiting

  • Florida Research Center Inc.

    Lakewood Rch, Florida, 34211

    Recruiting

  • GIA Kansas City

    Lee's Summit, Missouri, 64086

    Recruiting

  • United Medical Doctors

    Los Alamitos, California, 90720

    Recruiting

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

    Recruiting

  • GIA Metairie

    Metairie, Louisiana, 70006

    Recruiting

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157-6575

    Recruiting

  • New York Gastroenterology Associates

    New York, New York, 10075

    Recruiting

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73114

    Recruiting

  • Endoscopic Research Inc

    Orlando, Florida, 32803-1853

    Recruiting

  • The Oregon Clinic

    Portland, Oregon, 97220

    Recruiting

  • GIA Richmond

    Richmond, Virginia, 23229

    Recruiting

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

    Recruiting

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

    Recruiting

  • Mayo Clinic

    Scottsdale, Arizona, 85259

    Recruiting

  • Palmetto Primary and Specialty Care Physicians, Charleston

    Summerville, South Carolina, 29486

    Recruiting

  • GIA Sun City

    Sun City, Arizona, 85351

    Recruiting

  • Atlanta Gastroenterology Specialists

    Suwanee, Georgia, 30024

    Recruiting

  • GI Alliance Tacoma

    Tacoma, Washington, 98405

    Recruiting

  • GCP Clinical Research

    Tampa, Florida, 33609

    Recruiting

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

    Recruiting

  • Frontier Clinical Research

    Uniontown, Pennsylvania, 15401

    Recruiting

  • GIA Webster

    Webster, Texas, 77598

    Recruiting

Other trials in United States

China27 sites, 27 recruiting

  • China Japan Friendship Hospital

    Beijing, 100013

    Recruiting

  • Beijing Friendship Hospital Capital Medical University

    Beijing, 100050

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213000

    Recruiting

  • West China Hospital Si Chuan University

    Chengdu, 610041

    Recruiting

  • Chongqing General Hospital

    Chongqing, 400014

    Recruiting

  • The First People's Hospital of Foshan

    Foshan, 528010

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350004

    Recruiting

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260

    Recruiting

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

    Guangzhou, 510655

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

    Recruiting

  • Huai'an 1st Hospital

    Huai'an, 223300

    Recruiting

  • Jinhua municipal central hospital

    Jinhua, 321013

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, 730030

    Recruiting

  • The first affiliated hospital of Henan University of science and technology

    Luoyang, 471003

    Recruiting

  • Ningbo medical center lihuili hospital

    Ningbo, 315000

    Recruiting

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050000

    Recruiting

  • Taihe Hospital

    Shiyan, 442000

    Recruiting

  • Second Affiliated Hospital, SooChow University

    Suzhou, 215004

    Recruiting

  • Zhongshan Hospital, Xiamen University

    Xiamen, 361004

    Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450014

    Recruiting

  • ZhuZhou Central Hospital

    Zhuzhou, 412007

    Recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563099

    Recruiting

Other trials in China

Japan25 sites, 25 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

    Recruiting

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

    Recruiting

  • Matsuda Hospital

    Hamamatsu, 432-8061

    Recruiting

  • National Hospital Organization Mito Medical Center

    Higashiharima, 311-3193

    Recruiting

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

    Recruiting

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556

    Recruiting

  • Takano Hospital

    Kumamoto, 862-0971

    Recruiting

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

    Recruiting

  • Kyorin University Hospital

    Mitaka, 181-8611

    Recruiting

  • Aichi Medical University Hospital

    Nagakute, 480-1195

    Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya, 663 8501

    Recruiting

  • Oita Red Cross Hospital

    Ōita, 870-0033

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8585

    Recruiting

  • Saga University Hospital

    Saga, 849-8501

    Recruiting

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

    Sapporo, 060-0033

    Recruiting

  • Sapporo Medical University Hospital

    Sapporo, 060-8543

    Recruiting

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

    Recruiting

  • National Hospital Organization Shizuoka Medical Center

    Shimizu, 411-8611

    Recruiting

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, 162 8655

    Recruiting

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Tokyo, 130 8575

    Recruiting

  • The Jikei University Hospital

    Tokyo, 105-8471

    Recruiting

  • Yamanashi Prefectural Central Hospital

    Yamanashi, 400-8506

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024

    Recruiting

Other trials in Japan

Germany18 sites, 18 recruiting

  • Gastroenterologische Spezialpraxis - Berlin-Karlshorst

    Berlin, 10318

    Recruiting

  • Praxis Fur Gastroenteroligie

    Berlin, 10825

    Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin, 12203

    Recruiting

  • Krankenhaus Waldfriede Mitte

    Berlin, 14163

    Recruiting

  • Medizinisches Versorgungszentrum (MVZ) Dachau

    Dachau, 85221

    Recruiting

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

    Recruiting

  • Universitaetsklinik Erlangen

    Erlangen, 91054

    Recruiting

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Universitatsklinikum Jena

    Jena, 07747

    Recruiting

  • Gastroenterologie Opernstrasse

    Kassel, 34117

    Recruiting

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

    Recruiting

  • Eugastro GmbH

    Leipzig, 04103

    Recruiting

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

    Recruiting

  • Klinikum Grosshadern Der Ludwig-Maximilians-Universitat

    München, 81377

    Recruiting

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

    München, 81675

    Recruiting

  • Universitaetsmedizin Rostock

    Rostock, 18057

    Recruiting

  • Universitatsklinikum Ulm

    Ulm, 89070

    Recruiting

Other trials in Germany

Poland17 sites, 17 recruiting

  • Centrum Medyczne Medis ManerMed Sp Z O O

    Bydgoszcz, 85 229

    Recruiting

  • Centrum Medyczne Plejady

    Krakow, 30 363

    Recruiting

  • Centrum Medyczne Promed

    Krakow, 31-513

    Recruiting

  • Medrise Sp. z o.o.

    Lublin, 20 582

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-090

    Recruiting

  • Medicus Zaniewski i Bilski

    Olsztyn, 10-684

    Recruiting

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45-819

    Recruiting

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

    Recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

    Recruiting

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

    Recruiting

  • GASTROMED Sp. z o.o.

    Torun, 87 100

    Recruiting

  • H-T Centrum Medyczne

    Tychy, 43 100

    Recruiting

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02 781

    Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501

    Recruiting

  • Centrum Medyczne Oporow

    Wroclaw, 52 416

    Recruiting

  • EMC Instytut Medyczny S A Penta Hospitals Przychodnie

    Wroclaw, 54-239

    Recruiting

  • ETG Zamosc

    Zamość, 22 400

    Recruiting

Other trials in Poland

France15 sites, 15 recruiting

  • CHU Amiens

    Amiens, 80000

    Recruiting

  • Hopital Jean Minjoz

    Besançon, 25000

    Recruiting

  • Hopital Beaujon

    Clichy, 92110

    Recruiting

  • APHP - Hopital Henri Mondor

    Créteil, 94000

    Recruiting

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270

    Recruiting

  • CHU de Lille Hopital Claude Huriez

    Lille, 59037

    Recruiting

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34090

    Recruiting

  • CHU de Nantes hotel Dieu

    Nantes, 44000

    Recruiting

  • CHU de Nice Hopital de l Archet 2

    Nice, 06202

    Recruiting

  • Centre Hospitalier Lyon Sud

    Oullins, 69495

    Recruiting

  • Hopital Haut Leveque CHU de Bordeaux

    Pessac, 33600

    Recruiting

  • CHU de Reims

    Reims, 51100

    Recruiting

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

    Recruiting

  • CHU Toulouse

    Toulouse, 31059

    Recruiting

  • CHRU de Nancy - Hopitaux de Brabois

    Vanduvre-lès-Nancy, 54500

    Recruiting

Other trials in France

Brazil13 sites, 13 recruiting

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

    Botucatu, 18618-686

    Recruiting

  • CDC - Centro Digestivo de Curitiba

    Curitiba, 80430 180

    Recruiting

  • CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda

    Jaú, 17206-607

    Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

    Recruiting

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096

    Recruiting

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035-903

    Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-092

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14051140

    Recruiting

  • Pesquisare Saude

    Santo André, 09080-110

    Recruiting

  • BR Trials

    São Paulo, 01236 030

    Recruiting

  • Solare Trials

    São Paulo, 01307 002

    Recruiting

  • Rocco And Nazato Servicos Medicos Ltda

    São Paulo, 04077-020

    Recruiting

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 15500-269

    Recruiting

Other trials in Brazil

United Kingdom12 sites, 12 recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Cardiff and Vale UHB - University Hospital of Wales

    Cardiff, CF14 4XW

    Recruiting

  • Russells Hall Hospital

    Dudley, DY1 2HQ

    Recruiting

  • Ninewells Hospital

    Dundee, DD2 1GZ

    Recruiting

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW

    Recruiting

  • Fairfield General Hospital

    Great Chart, BL9 7TD

    Recruiting

  • Whipps Cross University Hospital

    Leyton, E11 1NR

    Recruiting

  • Guys' and St Thomas' NHS Trust

    London, SE1 9RT

    Recruiting

  • Kings College Hospital

    London, SE5 9RS

    Recruiting

  • St Georges Healthcare NHS Trust

    London, SW17 0QT

    Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

    Recruiting

Other trials in United Kingdom

Canada10 sites, 10 recruiting

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

    Recruiting

  • South Edmonton Gastroenterology Research Clinic

    Edmonton, Alberta, Code: T6K

    Recruiting

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

    Recruiting

  • Charlton Digestive Disease Centre

    Hamilton, Ontario, L8N1Y2

    Recruiting

  • Viable Clinical Research

    Kentville, Nova Scotia, B4N 0A3

    Recruiting

  • London Digestive Disease Institute

    London, Ontario, N6K 1M6

    Recruiting

  • CHUM - Centre hospitalier universitaire de Montreal

    Montreal, Quebec, H2X 0C1

    Recruiting

  • Clinique IMD

    Montreal, Quebec, H3H1E3

    Recruiting

  • Toronto Immune and Digestive Health Institute Inc

    Toronto, Ontario, M6A 3B4

    Recruiting

  • GI Research Institute (G.I.R.I.)

    Vancouver, British Columbia, V6Z 2K5

    Recruiting

Other trials in Canada

Israel10 sites, 10 recruiting

  • Assuta Medical center

    Ashdod, 7747629

    Recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Bnai Zion Medical Center

    Haifa, 60910

    Recruiting

  • Wolfson Medical Center

    Holon/Tel Aviv, 5822012

    Recruiting

  • Meir Medical Center

    Kefar Sava, 4428164

    Recruiting

  • Galilee Medical Center

    Nahariya, 2210001

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Recruiting

  • Shaare Zedek Medical Center

    Yeruham, 9103102

    Recruiting

Other trials in Israel

Australia9 sites, 9 recruiting

  • Banksia Trials SA

    Adelaide, 5000

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, 2050

    Recruiting

  • Monash Medical Centre

    Clayton, 3168

    Recruiting

  • SA Gastrointestinal Services

    Kurraba Point, 5037

    Recruiting

  • Macquarie University

    Macquarie Island, 2109

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, 6150

    Recruiting

  • John Hunter Hospital

    New Lambton, 2305

    Recruiting

  • Mater Misericordiae Hospital

    South Brisbane, 4101

    Recruiting

  • The Melbourne Gut Clinic Epworth Hospital

    West Melbourne, 3002

    Recruiting

Other trials in Australia

Belgium9 sites, 9 recruiting

  • Imelda Bonheiden

    Bonheiden, 2820

    Recruiting

  • AZ Sint-Lucas

    Brugge (Bruges), 8310

    Recruiting

  • UZ Brussel

    Brussel (Bruxelles), 1090

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussel (Bruxelles), 1200

    Recruiting

  • AZ Maria Middelares

    Gent (Ghent), 9000

    Recruiting

  • Ghent University Hospital

    Gent (Ghent), 9000

    Recruiting

  • ULB Erasme Ziekenhuis

    Koekelberg/Brussel (Bruxelles), 1070

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • CHC MontLegia

    Liège, 4000

    Recruiting

Other trials in Belgium

Czechia9 sites, 9 recruiting

  • SurGal Clinic

    Brno, 602 00

    Recruiting

  • Nemocnice Ceske Budejovice a s

    České Budějovice, 37001

    Recruiting

  • Gastroenterologie, s.r.o., Hradec Kralove

    Hradec Králové, 500 02

    Recruiting

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

    Recruiting

  • Oblastni nemocnice Kladno a.s.

    Kladno, 27259

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava, 70852

    Recruiting

  • IKEM

    Prague, 140 00

    Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, 14000

    Recruiting

  • ISCARE a.s.

    Prague, 190 00

    Recruiting

Other trials in Czechia

Bulgaria8 sites, 8 recruiting

  • MHAT Sv. Karidad EAD

    Plovdiv, 4004

    Recruiting

  • Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

    Sofia, 1407

    Recruiting

  • Diagnostic Consultative Center Neoclinic EAD

    Sofia, 1408

    Recruiting

  • St Ivan Rilski University Multiprofile Hospital For Active Treatment

    Sofia, 1431

    Recruiting

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

    Sofia, 1527

    Recruiting

  • DCC Convex EOOD

    Sofia, 1680

    Recruiting

  • Acibadem City Clinic - Oncology Center

    Sofia, 1784

    Recruiting

  • Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

    Varna, 9010

    Recruiting

Other trials in Bulgaria

India8 sites, 8 recruiting

  • Sushruta Multispecialty Hospital and Research Centre

    Hubli, 580021

    Recruiting

  • Asian Institute Of Gastroenterology

    Hyderabad, 500032

    Recruiting

  • S. R. Kalla Memorial General Hospital

    Jaipur, 302006

    Recruiting

  • Lisie Hospital

    Kochi, 682018

    Recruiting

  • P D Hinduja National Hospital and Medical Research Center

    Mumbai (ex Bombay), 400016

    Recruiting

  • Yashoda Super Speciality Hospitals

    Secunderabad, 500003

    Recruiting

  • SIDS Hospital & Research Centre

    Surat, 395002

    Recruiting

  • Gujarat Gastro and Vascular Hospital

    Surat, 395009

    Recruiting

Other trials in India

Turkey (Türkiye)8 sites, 8 recruiting

  • Izmir Sehir Hastanesi

    ?zmir, 35540

    Recruiting

  • Antalya Training And Research Hospital

    Antalya, 07100

    Recruiting

  • Sanko Universitesi Hastanesi

    Gaziantep, 27090

    Recruiting

  • Bezmialem University Medical Faculty

    Istanbul, 34093

    Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

    Recruiting

  • Kocaeli University Medical Faculty

    Kocaeli, 41001

    Recruiting

  • Mersin University Medical Faculty

    Mersin, 33343

    Recruiting

  • Izmir Ataturk Egitim ve Arastirma Hastanesi

    Turanköy, 35360

    Recruiting

Other trials in Turkey (Türkiye)

Argentina7 sites, 7 recruiting

  • Instituto Medico De Alta Complejidad (IMAC)

    Buenos Aires, B1643CRO

    Recruiting

  • GEDYT

    Famailla, C1425BGC

    Recruiting

  • Globalpsy

    La Plata, 1896

    Recruiting

  • HIGEA

    Mendoza, M5500DPS

    Recruiting

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, B1878GEG

    Recruiting

  • Hospital Provincial del Centenario

    Rosario, S2000KDS

    Recruiting

  • MR Medicina Reumatologica

    San Fernando, B1646

    Recruiting

Other trials in Argentina

Italy7 sites, 7 recruiting

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milan, 20122

    Recruiting

  • Ospedale San Raffaele di Milano

    Milan, 20132

    Recruiting

  • Ospedale Sacro Cuore Negrar-Verona

    Negrar, 37024

    Recruiting

  • Azienda Ospedaliera San Camillo-Forlanini

    Romagnano, 00152

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Romagnano, 00168

    Recruiting

  • Fatebenefratelli Isola Tiberina - Gemelli Isola

    Romagnano, 00186

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

Slovakia7 sites, 7 recruiting

  • FNsP F. D. Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

    Recruiting

  • Cliniq s.r.o.

    Bratislava, 811 09

    Recruiting

  • ENDOMED s.r.o

    Košice, 040 13

    Recruiting

  • KM Management spol. s r.o.

    Nitra, 949 01

    Recruiting

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About this study

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

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).

Being tested
JNJ-78934804, Guselkumab
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-78934804Drug

    Also called JNJ-4804

    JNJ-78934804 will be administered subcutaneously.

  • GuselkumabDrug

    Also called TREMFYA

    Guselkumab will be administered subcutaneously.

Study groups in NCT07577856
Study groupRoleWhat they receive
JNJ-78934804ExperimentalParticipants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
Receives: Drug: JNJ-78934804
GuselkumabActive comparatorParticipants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
Receives: Drug: JNJ-78934804; Drug: Guselkumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants in Clinical Remission at Week 48

    Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week 48

Secondary outcomes (13)

  1. Percentage of Participants with Endoscopic Improvement at Week 48

    Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

    Measured: At Week 48

  2. Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48

    Corticosteroid-free (90 day) clinical remission is defined as clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.

    Measured: At Week 48

  3. Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48

    Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Histologic remission is defined as an absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.

    Measured: At Week 48

  4. Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48

    Fatigue response is defined as a greater than or equal to (>=) 7- point reduction in the patient-reported outcomes measurement information system (PROMIS) fatigue short form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).

    Measured: At Week 48

  5. Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0

    Percentage of participants with a SF subscore of 0 or 1 and RB subscore of 0 at three assessment time points of Week 12, Week 24, and Week 48 will be reported.

    Measured: At Weeks 12, 24, and 48

  6. Percentage of Participants in Abdominal Pain Remission at Week 48

    Percentage of participants in abdominal pain remission at week 48 will be reported.

    Measured: At Week 48

  7. Change From Baseline in Abdominal Pain Score at Week 48

    Change from baseline in abdominal pain score based on abdominal pain-numerical rating scale (AP-NRS) will be reported. NRS is 11 point (0 to 10) scoring system used to evaluate abdominal pain. The score of 0 represents "no pain" and the score of 10 represents "pain as bad as you can imagine", with greater scores indicating greater pain severity and intensity.

    Measured: Baseline and Week 48

  8. Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48

    IBDQ response is defined as improvement from baseline in the total IBDQ score of >= 16 points. The IBDQ is a 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).

    Measured: At Week 48

  9. Percentage of Participants with PROMIS-29 Mental Component Summary (MCS) Response at Week 48

    PROMIS 29 MCS response is defined as a >= 7-point improvement from baseline in PROMIS 29 MCS response at Week 48. The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities). The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression/anxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.

    Measured: At Week 48

  10. Percentage of Participants in Clinical Remission at Week 12

    Clinical remission is defined as an SF subscore of 0 or 1, RB subscore of 0, and an endoscopy subscore of 0 or 1.

    Measured: At Week 12

  11. Percentage of Participants with Endoscopic Improvement at Week 12

    Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

    Measured: At Week 12

  12. Percentage of Participants with Mayo SF/RB Response at Week 2

    Mayo SF/RB response is defined as a decrease from baseline in the sum of the SF and the RB subscores by >=30 percent (%) and >= 1 point, with either a >= 1 point decrease from baseline in the RB subscore or an RB subscore of 0 or 1.

    Measured: At Week 2

  13. Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start23 May 2026
  3. Primary completion11 Aug 2028 (estimated)
  4. Study completion16 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
644 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577856
Sponsor's protocol ID
78934804UCO3001
Other IDs
78934804UCO3001, 2026-525923-26-00
Acronym
DUET ENCORE-UC
Status last verified
Nov 2026
First submitted
5 May 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JNJ-78934804 and Guselkumab in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 318 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 318 sites in United States, China, Japan, Germany, Poland and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Clinical Remission at Week 48 (time frame: At Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07577856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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