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 252 sites in 30 countries.
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
- 252 sitesin 30 countries
- Study dates
- 22 May 2026to 12 Jul 2030
- Phase
- Phase 3
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
252 sites in 30 countries. Contact the study team or a site near you to ask about taking part.
252 sites in 30 countries
United States22 sites, 22 recruiting
- 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 Hills, Michigan, 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
The Oregon Clinic
Portland, Oregon, 97220
- Recruiting
Medical Associates Research Group, Inc.
San Diego, California, 92123
- 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
Japan22 sites, 22 recruiting
- 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 Shi, 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
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
China16 sites, 16 recruiting
- 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
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
Ningbo medical center lihuili hospital
Ningbo, 315041
- Recruiting
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
Poland16 sites, 16 recruiting
- 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' 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
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
Germany15 sites, 15 recruiting
- 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
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
Karlshorst, 10318
- Recruiting
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105
- Recruiting
Eugastro GmbH
Leipzig, 04103
- Recruiting
Universitaetsklinikum Mannheim
Mannheim, 68167
- 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
Brazil14 sites, 14 recruiting
- 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
Galileo Medical Research Ltda
Juiz de Fora, 36033-318
- Recruiting
Cliged
Macaé, 27910-020
- 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
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
France12 sites, 12 recruiting
- Recruiting
Hopital Jean Minjoz
Besançon, 25000
- Recruiting
Hopital Beaujon
Clichy, 92110
- 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
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, 31300
- Recruiting
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54500
Canada11 sites, 11 recruiting
- Recruiting
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Code: T6K 4B2
- 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
Israel10 sites, 10 recruiting
- Recruiting
Assuta Medical center
Ashdod, 7747629
- Recruiting
Bnai Zion Medical Center
Haifa, 31048
- Recruiting
Rambam Medical Center
Haifa, 3109601
- Recruiting
Wolfson Medical Center
Holon, 5822012
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- 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
Australia9 sites, 9 recruiting
- Recruiting
Banksia Trials SA
Adelaide, 5000
- Recruiting
Royal Prince Alfred Hospital
Camperdown, 2050
- Recruiting
Monash Medical Centre
Clayton, 3168
- Recruiting
The Melbourne Gut Clinic Epworth Hospital
East Melbourne, 3002
- Recruiting
SA Gastrointestinal Services IBD SA
Kurralta Park, 5037
- Recruiting
Macquarie University
Macquarie University, 2109
- Recruiting
Fiona Stanley Hospital
Murdoch, 6150
- Recruiting
John Hunter Hospital
New Lambton Heights, 2305
- Recruiting
Mater Misericordiae Hospital
South Brisbane, 4101
India8 sites, 8 recruiting
- Recruiting
Sushruta Multispecialty Hospital and Research Centre
Hubballi, 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, 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
United Kingdom8 sites, 8 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
- Recruiting
Cardiff and Vale UHB - University Hospital of Wales
Cardiff, CF14 4XW
- Recruiting
Ninewells Hospital
Dundee, DD2 1GZ
- 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
Italy7 sites, 7 recruiting
- 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-Verona, 37024
- Recruiting
Azienda Ospedaliera San Camillo-Forlanini
Roma, 00152
- Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
- Recruiting
Fatebenefratelli Isola Tiberina - Gemelli Isola
Roma, 00186
- Recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Slovakia7 sites, 7 recruiting
- 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
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Antalya Training And Research Hospital
Antalya, 07100
- Recruiting
Bezmialem University Medical Faculty
Istanbul, 34093
- Recruiting
Marmara University Pendik Training Hospital
Istanbul, 34899
- Recruiting
Izmir Sehir Hastanesi
Izmir, 35540
- Recruiting
Kocaeli University Medical Faculty
Kocaeli, 41001
- Recruiting
Mersin University Medical Faculty
Mersin, 33343
- Recruiting
Izmir Katip Celebi University Ataturk Training and Research Hospital
Turkey, 35360
Argentina6 sites, 6 recruiting
- Recruiting
GEDYT
AAI, C1425BGC
- Recruiting
Sanatorio Duarte Quiroz
Córdoba, X5002AOQ
- Recruiting
Globalpsy
La Plata, 1896
- Recruiting
HIGEA
Mendoza, M5500DPS
- Recruiting
Cer Instituto Medico
Quilmes, B1878DVB
- Recruiting
Hospital Provincial del Centenario
Rosario, S2000KDS
Belgium6 sites, 6 recruiting
- Recruiting
O L V Ziekenhuis
Aalst, 9300
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
- Recruiting
Ghent University Hospital
Ghent, 9000
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
- Recruiting
Algemeen Ziekenhuis Delta
Roeselare, 8800
Norway6 sites, 6 recruiting
- Recruiting
Alesund sjukehus
Ålesund, 6017
- Recruiting
Sykehuset Innlandet HF Gjøvik
Gjøvik, 2819
- Recruiting
Akershus Universitetssykehus
Lorenskog, 1474
- Recruiting
Sykehuset Ostfold
Moss, 1535
- Recruiting
Universitetssykehuset Nord-Norge HF
Tromsø, 9019
- Recruiting
St. Olavs Hospital
Trondheim, 7030
South Korea6 sites, 6 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
- Recruiting
The Catholic University of Korea Daejeon St Mary's Hospital
Daejeon, 34943
- Recruiting
Samsung Medical Center
Gangnam Gu, 06351
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Kyung Hee University Hospital
Seoul, 130 050
Spain6 sites, 6 recruiting
- Recruiting
Hosp. Arquitecto Marcide
Ferrol, 15405
- Recruiting
Hosp. de Cabuenes
Gijón, 33394
- Recruiting
Hosp. Univ. Infanta Leonor
Madrid, 28031
- Recruiting
Hosp. Virgen Macarena
Seville, 41009
- Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
- Recruiting
Hosp. Alvaro Cunqueiro
Vigo, 36312
Czechia5 sites, 5 recruiting
- Recruiting
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, 500 12
- Recruiting
Oblastni nemocnice Kladno a.s.
Kladno, 27259
- Recruiting
Fakultni Nemocnice Ostrava
Ostrava-Poruba, 708 00
- Recruiting
Fakultni Thomayerova nemocnice
Prague, 14000
- Recruiting
ISCARE a.s.
Prague, 190 00
Hungary5 sites, 5 recruiting
- Recruiting
Semmelweis Egyetem 1
Budapest, 1082
- Recruiting
Semmelweis Egyetem
Budapest, 1082
- Recruiting
Semmelweis Egyetem 2
Budapest, 1083
- Recruiting
Pannónia Magánorvosi Centrum Kft
Budapest, H-1136
- Recruiting
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725
Malaysia5 sites, 5 recruiting
- Recruiting
Hospital Ampang
Ampang, 68000
- Recruiting
Sultan Idris Shah Hospital
Kajang, 43000
- Recruiting
Hospital Queen Elizabeth
Kota Kinabalu, 88586
- Recruiting
Hospital Sultanah Nur Zahirah
Kuala, 20400
- Recruiting
University Malaya Medical Centre
Petaling Jaya, 50603
Portugal5 sites, 5 recruiting
- Recruiting
Uls Braga - Hosp. Braga
Braga, 4710 243
- Recruiting
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 035
- Recruiting
Uls Algarve Hosp Portimao
Portimão, 8500 338
- Recruiting
Uls Arrabida - Hosp. Sao Bernardo
Setúbal, 2910 549
- Recruiting
Ulsam - Hosp. Santa Luzia
Viana do Castelo, 4900-408
Romania5 sites, 5 recruiting
- 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
Oncohelp Medical Center
Timișoara, 300239
Taiwan4 sites, 4 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
- Recruiting
NTU Biomedical Park Hospital
Zhubei, 302
Austria3 sites, 3 recruiting
- Recruiting
Kepler Universitatsklinikum GmbH
Linz, 4021
- Recruiting
Krankenhaus der Barmherzigen Brüder
Vienna, 1020
- Recruiting
Klinikum Wels Grieskirchen
Wels, 4600
Netherlands3 sites, 3 recruiting
- Recruiting
Vrije Universiteit Medisch Centrum
Amsterdam, 1081 HV
- Recruiting
Radboud Umcn
Nijmegen, 6525 GA
- Recruiting
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC
Greece2 sites, 2 recruiting
- Recruiting
General Hospital of Athens Evaggelismos
Athens, 115 21
- Recruiting
Thoracic General Hospital Of Athens I Sotiria
Athens, 11527
Switzerland1 site, 1 recruiting
- Recruiting
Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern
Bern, 3001
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 group | Role | What they receive |
|---|---|---|
| JNJ-78934804 | Experimental | Participants 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 |
| Guselkumab | Active comparator | Participants 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted11 May 2026
- Study start22 May 2026
- Primary completion12 Jun 2028 (estimated)
- Study completion12 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
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
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 14 Oct 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.