AzTrials
AzTrials

Crohn DiseasePhase 3DUET ENCORE-CDNCT07577843

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

A Phase 3 study testing JNJ-78934804 and Guselkumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 287 sites in 30 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 Crohn's disease (a long-term, progressive [worsens with time] and life-threatening disease of the intestine). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
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
460 participants
Where
287 sitesin 30 countries
Study dates
22 May 2026to 12 Jul 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

  • 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

Who cannot join

  • 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

Trial locations and contacts

287 sites in 30 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

287 sites in 30 countries

United States29 sites, 29 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

  • GIA Rochester

    Rochester, New York, 14618

    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

  • GIA Webster

    Webster, Texas, 77598

    Recruiting

Other trials in United States

Japan24 sites, 24 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

    Recruiting

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

    Recruiting

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, 036-8545

    Recruiting

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

    Recruiting

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

    Recruiting

  • Kobe University Hospital

    Kobe, 650 0017

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556

    Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

    Recruiting

  • Takano Hospital

    Kumamoto, 862-0971

    Recruiting

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

    Recruiting

  • Kyorin University Hospital

    Mitaka, 181-8611

    Recruiting

  • Nagoya City University Hospital

    Nagoya, 467-8602

    Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya, 663 8501

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

    Recruiting

  • Japanese Red Cross Osaka Hospital

    Osaka, 543-8555

    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

  • Tohoku University Hospital

    Sendai, 980 8574

    Recruiting

  • National Hospital Organization Shizuoka Medical Center

    Shimizu, 411-8611

    Recruiting

  • Takamatsu Red Cross Hospital

    Takamatsu, 760-0017

    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

China20 sites, 19 recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Recruiting

  • The second Xiangya Hospital of Central South University

    Changsha, 410011

    Recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004

    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

  • 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, 310000

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

    Recruiting

  • Huai'an 1st Hospital

    Huai'an, 223300

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, 730030

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, 210029

    Recruiting

  • Ningbo medical center lihuili hospital

    Ningbo, 315041

    Recruiting

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

    Recruiting

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 60288420

    Suspended

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

  • The Central Hospital of Wuhan

    Wuhan, 430014

    Recruiting

  • Wuxi People s Hospital

    Wuxi, 214028

    Recruiting

  • Zhongshan Hospital, Xiamen University

    Xiamen, 361004

    Recruiting

  • ZhuZhou Central Hospital

    Zhuzhou, 412007

    Recruiting

Other trials in China

Germany19 sites, 19 recruiting

  • Universitaetsklinikum Augsburg

    Augsburg, 86156

    Recruiting

  • Gastroenterologische Spezialpraxis - Berlin-Karlshorst

    Berlin, 10318

    Recruiting

  • Praxis Fur Gastroenteroligie

    Berlin, 10825

    Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin, 12203

    Recruiting

  • DRK Kliniken Westend

    Berlin, 14050

    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

  • 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

Poland18 sites, 18 recruiting

  • Centrum Medyczne Medis ManerMed Sp Z O O

    Bydgoszcz, 85 229

    Recruiting

  • M2M Badania Kliniczne

    Chorzów, 41-500

    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' Sp. z o.o. K.

    Rzeszów, 35-055

    Recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

    Recruiting

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

    Recruiting

  • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii

    Torun, 87 100

    Recruiting

  • H-T Centrum Medyczne

    Tychy, 43 100

    Recruiting

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02 781

    Recruiting

  • Medical Network

    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

Brazil17 sites, 17 recruiting

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

    Botucatu, 18618-686

    Recruiting

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200 730

    Recruiting

  • CDC - Centro Digestivo de Curitiba

    Curitiba, 80430 180

    Recruiting

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

    Jaú, 17206-607

    Recruiting

  • Galileo Medical Research Ltda

    Juiz de Fora, 36033-318

    Recruiting

  • Cliged

    Macaé, 27910-020

    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 093

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14051140

    Recruiting

  • Clinica Ibis Medicina Ltda

    Salvador, 41820020

    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

France16 sites, 16 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

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200

    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

  • Centre Hospitalier Universitaire de Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

    Recruiting

  • CHU Toulouse

    Toulouse, 31400

    Recruiting

  • CHRU de Nancy - Hopitaux de Brabois

    Vanduvre-lès-Nancy, 54500

    Recruiting

Other trials in France

United Kingdom12 sites, 11 recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

    Recruiting

  • Fairfield General Hospital

    Bury, BL9 7TD

    Recruiting

  • Cardiff and Vale UHB - University Hospital of Wales

    Cardiff, CF14 4XW

    Recruiting

  • Ninewells Hospital

    Dundee, DD2 1GZ

    Recruiting

  • Ulster Hospital

    Dundonald, BT16 1RH

    Recruiting

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW

    Recruiting

  • Glasgow Royal Infirmary

    Glasgow, G31 2ER

    Recruiting

  • Kings College Hospital

    London, SE5 9RS

    Recruiting

  • Chelsea And Westminster Hospital

    London, SW10 9NH

    Recruiting

  • St Georges Healthcare NHS Trust

    London, SW17 0QT

    Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

    Active, not recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

    Recruiting

Other trials in United Kingdom

Canada11 sites, 11 recruiting

  • South Edmonton Gastroenterology Research Clinic

    Edmonton, Alberta, Code: T6K

    Recruiting

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

    Recruiting

  • Nova Scotia Health Victoria General Site

    Halifax, Nova Scotia, B3H 2Y9

    Recruiting

  • Viable Clinical Research

    Kentville, Nova Scotia, B4N 0A3

    Recruiting

  • London Digestive Disease Institute

    London, Ontario, N6K 1M6

    Recruiting

  • West GTA Research Inc

    Mississauga, Ontario, L5M 2S4

    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

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario, L4L 4Y7

    Recruiting

Other trials in Canada

Israel10 sites, 10 recruiting

  • Assuta Medical center

    Ashdod, 7747629

    Recruiting

  • Bnai Zion Medical Center

    Haifa, 31048

    Recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Wolfson Medical Center

    Holon/Tel Aviv, 5822012

    Recruiting

  • Meir Medical Center

    Kfar Saba, 44281

    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 IBD SA

    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

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 (Surat Institute of Digestive Sciences) Hospital and Research Centre

    Surat, 395002

    Recruiting

  • Gujarat Gastro and Vascular Hospital

    Surat, 395009

    Recruiting

Other trials in India

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

  • GASTRO I. s.r.o.

    Prešov, 080 01

    Recruiting

  • Gastro LM s.r.o.

    Prešov, 080 01

    Recruiting

  • Ustredna Vojenska Nemocnica SNP Ruzomberok- Fakultna Nemocnica

    Ružomberok, 03401

    Recruiting

Other trials in Slovakia

Turkey (Türkiye)7 sites, 7 recruiting

  • Izmir Sehir Hastanesi

    ?zmir, 35540

    Recruiting

  • Antalya Training And Research Hospital

    Antalya, 07100

    Recruiting

  • Bezmialem University Medical Faculty

    Istanbul, 34093

    Recruiting

  • Marmara University Pendik Training Hospital

    Istanbul, 34899

    Recruiting

  • Kocaeli University Medical Faculty

    Kocaeli, 41001

    Recruiting

  • Mersin University Medical Faculty

    Mersin, 33343

    Recruiting

  • Izmir Katip Celebi University Ataturk Training and Research Hospital

    Turanköy, 35360

    Recruiting

Other trials in Turkey (Türkiye)

Argentina6 sites, 6 recruiting

  • Sanatorio Duarte Quiroz

    Córdoba, X5002AOQ

    Recruiting

  • GEDYT

    Famailla, C1425BGC

    Recruiting

  • Globalpsy

    La Plata, 1896

    Recruiting

  • HIGEA

    Mendoza, M5500DPS

    Recruiting

  • Cer Instituto Medico

    Quilmes, B1878DVB

    Recruiting

  • Hospital Provincial del Centenario

    Rosario, S2000KDS

    Recruiting

Other trials in Argentina

Belgium6 sites, 6 recruiting

  • O L V Ziekenhuis

    Aalst, 9300

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussel (Bruxelles), 1200

    Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Recruiting

  • Ghent University Hospital

    Gent (Ghent), 9000

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Czechia6 sites, 6 recruiting

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

    Hradec Králové, 500 12

    Recruiting

  • Oblastni nemocnice Kladno a.s.

    Kladno, 27259

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 00

    Recruiting

  • IKEM

    Prague, 140 00

    Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, 14000

    Recruiting

  • ISCARE a.s.

    Prague, 190 00

    Recruiting

Other trials in Czechia

Norway6 sites, 6 recruiting

  • Alesund sjukehus

    Ålesund, 6017

    Recruiting

  • Sykehuset Innlandet HF Gjøvik

    Gjøvik, 2819

    Recruiting

  • Akershus Universitetssykehus

    Lørenskog, 1474

    Recruiting

  • Sykehuset Ostfold

    Moss, 1535

    Recruiting

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9019

    Recruiting

  • St. Olavs Hospital

    Trondheim, 7030

    Recruiting

Other trials in Norway

Romania6 sites, 6 recruiting

  • Baneasa Tumor Center Hospital

    Bucharest, 013685

    Recruiting

  • Spitalul Clinic Colentina

    Bucharest, 020125

    Recruiting

  • Institutul Clinic Fundeni

    Bucharest, 022328

    Recruiting

  • Gastro Med S R L

    Cluj-Napoca, 400380

    Recruiting

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About this study

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

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).

Conditions
Crohn Disease
Being tested
JNJ-78934804, Guselkumab
Medical subject headings
Crohn Disease

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 NCT07577843
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 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 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. Co-Primary: Percentage of Participants with Clinical Remission at Week 48

    Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 48

  2. Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48

    Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

    Measured: At Week 48

Secondary outcomes (12)

  1. Percentage of Participants with Deep Remission at Week 48

    Deep remission (composite endpoint) is defined as achieving both clinical remission and endoscopic remission at Week 48 at the participant level. Clinical remission is defined as a CDAI score of <150 and Endoscopic remission is defined as a SES-CD score of <= 4 with at least a 2-point reduction from baseline and no subscore >1 in any individual component. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

    Measured: At Week 48

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

    Corticosteroid-free (90-day) clinical remission at Week 48 is defined as clinical remission at Week 48 and not receiving corticosteroids for at least 90 days prior to Week 48. Clinical remission is defined as a CDAI score of <150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 48

  3. Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48

    Corticosteroid-free (90-day) patient-reported outcome(s) (PRO-2) remission at Week 48 is defined as an abdominal plan (AP) mean daily score less than or equal to (<=) 1 and stool frequency (SF) mean daily score <= 2.8, and no worsening of AP or SF from baseline, and not receiving corticosteroids for at least 90 days prior to Week 48.

    Measured: At Week 48

  4. Percentage of Participants with Sustained Clinical Remission

    Sustained clinical remission is defined as clinical remission at Week 12 and Week 48. Clinical remission is defined as CDAI score of <150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Weeks 12 and 48

  5. Percentage of Participants with Histologic-Endoscopic Remission at Week 48

    Composite endpoint defined as achieving both histologic remission (defined as a Robarts Histopathology Index score less than or equal to [<=] 3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0) and endoscopic remission at the participant level.

    Measured: At Week 48

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

    IBDQ response at Week 48 is defined as an improvement of at least 16 points in the IBDQ total score from baseline at Week 48. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, AP), systemic function (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Measured: At Week 48

  7. Percentage of Participants with Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48

    PROMIS-29 MCS response at Week 48 is defined as an improvement of at least 7 points in PROMIS-29 MCS score from baseline 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). PROMIS-29 also includes an overall average pain intensity 0-10 numeric rating scale. 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

  8. Percentage of Participants with Clinical Remission at Week 12

    Clinical remission at Week 12 is defined as CDAI score <150 at Week 12. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 12

  9. Percentage of Participants with Endoscopic Response at Week 12

    Endoscopic response at Week 12 is defined as greater than (>) 50 percent (%) improvement from baseline in SES-CD score at Week 12 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

    Measured: At Week 12

  10. Percentage of Participants with Clinical Response at Week 4

    Clinical response at week 4 is defined as >=100-point reduction from baseline in CDAI score at Week 4. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 4

  11. Percentage of Participants with Clinical Remission at Week 4

    Clinical remission at Week 4 is defined as CDAI score <150 at Week 4. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 4

  12. Number 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 start22 May 2026
  3. Primary completion12 Jun 2028 (estimated)
  4. Study completion12 Jul 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
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577843
Sponsor's protocol ID
78934804CRD3001
Other IDs
2026-525922-39-00
Acronym
DUET ENCORE-CD
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 Crohn Disease, run by Janssen Research & Development, LLC at 287 sites in 30 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 287 sites in United States, Japan, China, Germany, Poland and 25 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?

Co-Primary: Percentage of Participants with Clinical Remission at Week 48 (time frame: At Week 48). The study lists 2 primary outcomes in all. 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 NCT07577843.

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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