A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD)

May 21, 2026 updated by: Janssen Research & Development, LLC

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Study Overview

Status

Active, not recruiting

Conditions

Crohn's Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

703

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Adelaide, Australia, 5011
    - The Queen Elizabeth Hospital
  - Box Hill, Australia, 3128
    - Box Hill Hospital
  - Clayton, Australia, 3168
    - Monash Health, Monash Medical Centre
  - Footscray, Australia, 3011
    - Western Health
  - Melbourne, Australia, 3002
    - St Vincent's Hospital
  - Newtown, Australia, 2042
    - Royal Prince Alfred Hospital
  - North Terrace, Australia, 5000
    - Royal Adelaide Hospital
  - Parkville, Australia, 3050
    - Royal Melbourne Hospital
  - Penrith, Australia, 2747
    - Nepean Hospital
  - South Brisbane, Australia, 4101
    - Mater Hospital Brisbane Inflammatory Bowel Diseases
Austria
- - Salzburg, Austria, 5020
    - Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III
  - Vienna, Austria, 1090
    - AKH Wien
  - Vienna, Austria, 1090
    - Akh Wien 1
  - Wels, Austria, 4600
    - Klinikum Wels Grieskirchen
Belgium
- - Antwerp, Belgium, 2018
    - GZA Ziekenhuizen
  - Bruges, Belgium, 8000
    - Algemeen Ziekenhuis Sint-Jan
  - Brussels, Belgium, 1200
    - Cliniques Universitaires Saint Luc
  - Ghent, Belgium, 9000
    - AZ Maria Middelares
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liège, Belgium, 4000
    - CHU de Liege
  - Liège, Belgium, 4000
    - CHC MontLegia
  - Mechelen, Belgium, 2800
    - Az Sint-Maarten
  - Roeselare, Belgium, 8800
    - Algemeen Ziekenhuis Delta
  - Sint-Niklaas, Belgium
    - Vitaz
Brazil
- - Belo Horizonte - MG, Brazil, 30130-100
    - Hospital das Clínicas da UFMG
  - Botucatu, Brazil, 18608-025
    - Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
  - Brasília, Brazil, 72145 450
    - Chronos Clinica Medica Ltda
  - Brasília, Brazil, 71.681-603
    - Impar Servicos Hospitalares S/A - Hospital Brasilia
  - Curitiba, Brazil, 80430-180
    - Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
  - Jaú, Brazil, 17201-130
    - Centro de Estudos Clínicos do Interior Paulista - CECIP
  - Natal, Brazil, 59062 000
    - Liga Norte Riograndense Contra O Cancer
  - Porto Alegre, Brazil, 90035-003
    - Hospital das Clinicas de Porto Alegre
  - Porto Alegre, Brazil, 90035-001
    - Associacao Hospitalar Moinhos de Vento
  - Porto Alegre, Brazil, 90430-001
    - NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
  - Porto Alegre, Brazil, 90020 090
    - Irmandade da Santa Casa de Misericordia de Porto Alegre
  - Ribeirão Preto, Brazil, 14048-900
    - Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
  - Rio de Janeiro, Brazil, 21941-913
    - Universidade Federal do Rio de Janeiro - Faculdade de Medicina
  - Santo André, Brazil, 09080-110
    - Pesquisare Saude
  - Santos, Brazil, 11075-101
    - Irmandade da Santa Casa da Misericórdia de Santos
  - São José do Rio Preto, Brazil, 15015-110
    - Kaiser Hospta
  - São Paulo, Brazil, 05003-090
    - BR Trials
  - São Paulo, Brazil, 01228-200
    - CPCLIN - Centro de Pesquisas Clínicas
  - São Paulo, Brazil, 04502-001
    - Instituto D Or de Pesquisa e Ensino IDOR
  - São Paulo, Brazil, 04039-004
    - Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  - São Paulo, Brazil, 04543-011
    - Hepatogastro
  - São Paulo, Brazil, 01409 902
    - Hospital Nove de Julho
  - São Paulo, Brazil, 01228 000
    - CPQuali Pesquisa Clinica LTDA ME
Bulgaria
- - Sofia, Bulgaria, 1431
    - UMHAT 'Aleksandrovska' EAD
  - Sofia, Bulgaria, 1527
    - MHAT Tzaritza Joanna
Canada
- - Bridgewater, Canada, B4V 3N2
    - Viable Clinical Research
  - Saguenay, Canada, G7H3C3
    - Hopital Chicoutimi
- Alberta
  - Calgary, Alberta, Canada, T2N4N1
    - Foothills Hospital
  - Edmonton, Alberta, Canada, T6G 2X8
    - University of Alberta Hospital
  - Edmonton, Alberta, Canada, T5R 1W2
    - Gastroenterology and Internal Medicine Research Institute (GIRI)
  - Edmonton, Alberta, Canada, T6K 4B2
    - Covenant Health/Grey Nuns hospital
- British Columbia
  - New Westminster, British Columbia, Canada, V3L 3W4
    - Fraser Clinical Trials Inc.
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - The Gordon & Leslie Diamond Health Care Center
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - GIRI Gastrointestinal Research Institute
  - Vancouver, British Columbia, Canada, V7M 2H4
    - The Medical Arts Health Research Group
  - Victoria, British Columbia, Canada, V8P 2P5
    - PerCuro Clinical Research Ltd.
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1R9
    - Winnipeg Health Sciences Centre
- Nova Scotia
  - Dartmouth, Nova Scotia, Canada, B2W 6L4
    - Viable Clinical Research 1
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Health Authority
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Barrie GI Associates
  - London, Ontario, Canada, N6A 5A5
    - London Health Sciences Centre
  - Toronto, Ontario, Canada, M6A 3B4
    - Toronto Immune and Digestive Health Institute Inc
- Quebec
  - Montreal, Quebec, Canada, H1T 2M4
    - CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
  - Montreal, Quebec, Canada, H3G 1A4
    - McGill University - Health Centre - Montreal General Hospital
  - Saint-Jérôme, Quebec, Canada, J7Z 5T3
    - St. Jerome Medical Research
  - Ville Mont-Royal, Quebec, Canada, H3P-3E5
    - CMIIM, Centre médical L'Enjeu
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Royal University Hospital
China
- - Beijing, China, 100029
    - China Japan Friendship Hospital
  - Changsha, China, 200120
    - The second Xiangya hospital of central south university
  - Changzhou, China, 213004
    - Changzhou No 2 Peoples Hospital
  - Chengdu, China, 610041
    - West China Hospital Sichuan University
  - Chongqing, China, 400013
    - Chongqing Medical University
  - Foshan, China, 528010
    - The First People's Hospital of Foshan
  - Guangzhou, China, 510180
    - Guangzhou First Municipal People's Hospital
  - Guangzhou, China, 510515
    - Nanfang Hospital of Southern Medical Hospital
  - Guangzhou, China, 510000
    - Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
  - Haikou, China, 570311
    - Hainan General Hospital
  - Hangzhou, China, 310016
    - Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  - Jinhua, China, 321000
    - Jinhua municipal central hospital
  - Nanchang, China, 330006
    - The First Affiliated Hospital of NanChang University
  - Nanjing, China, 210008
    - Nanjing Drum Tower Hospital
  - Nanjing, China, 210000
    - Zhongda Hospital Southeast University
  - Shanghai, China, 200120
    - Shanghai East Hospital
  - Shanghai, China
    - Ruijin Hospital Shanghai Jiao Tong University
  - Wuhan, China, 430014
    - The Central Hospital of Wuhan
  - Wuhan, China, 430060
    - Renmin Hospital of Wuhan University
  - Wuhan, China, 430022
    - Wuhan Union Hospital
  - Wuxi, China, 214023
    - Wuxi People s Hospital
  - Xiamen, China, 361004
    - Zhongshan Hospital, Xiamen University
  - Yangzhou, China, 225001
    - Yangzhou First People's Hospital
  - Zhuzhou, China, 412007
    - ZhuZhou Central Hospital
Croatia
- - Bjelovar, Croatia, 43000
    - Opca bolnica Bjelovar
  - Split, Croatia, 21000
    - University Hospital Center Split
  - Zagreb, Croatia, 10000
    - University Hospital Dubrava
Czechia
- - Brno, Czechia, 636 00
    - Vojenska nemocnice Brno
  - Prague, Czechia, 190 00
    - ISCARE a.s.
  - Ústí nad Labem, Czechia, 401 11
    - Detska klinika Masarykovy nemocnice v Usti nad Labem
Denmark
- - Aarhus, Denmark
    - Aarhus University Hospital
  - Copenhagen, Denmark, 2400
    - Bispebjerg Og Frederiksberg Hospital
  - Herlev, Denmark, 2730
    - Herlev Hospital, University of Copenhagen
  - Odense, Denmark, 5000
    - Odense Universitetshospital
  - Silkeborg, Denmark, 8600
    - Silkeborg Hospital
Estonia
- - Tallinn, Estonia, 10617
    - West Tallinn Central Hospital
  - Tallinn, Estonia, 13419
    - Tallinn Children's Hospital
  - Tartu, Estonia, 50406
    - Tartu University Hospital
France
- - Amiens, France, 80054
    - CHU Amiens - Hopital Sud
  - Besançon, France, 25030
    - CHRU De Besancon
  - Créteil, France, 94010
    - Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
  - Grenoble, France, 38700
    - CHU Grenoble
  - Marseille, France, 13915
    - Hopital Nord Marseille
  - Nantes, France, 44093
    - CHU de Nantes hotel Dieu
  - Neuilly-sur-Seine, France, 92200
    - Clinique Ambroise Pare
  - Nice, France, 06202
    - CHU de Nice Hopital de l Archet
  - Paris, France, 75010
    - Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux
  - Pierre-Bénite, France, 69495
    - Centre Hospitalier Lyon Sud
  - Rennes, France, 35033
    - CHRU Hopital de Pontchaillou
  - Saint-Brieuc, France, 22027
    - Hôpital Yves Le Foll
  - Saint-Etienne, France, 42055
    - Centre hospitalier universitaire de St Etienne
  - Toulouse, France, 31059
    - CHU Rangueil
  - Vandœuvre-lès-Nancy, France, 54511
    - CHRU Nancy Brabois
Germany
- - Berlin, Germany, 10117
    - Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  - Berlin, Germany, 12200
    - Charite Campus Benjamin Franklin
  - Berlin, Germany, 14163
    - Krankenhaus Waldfriede Mitte
  - Berlin, Germany, 10825
    - Praxis Fur Gastroenteroligie
  - Cologne, Germany, 51103
    - Evangelisches Krankenhaus Kalk
  - Dachau, Germany, 85221
    - Medizinisches Versorgungszentrum (MVZ) Dachau
  - Dresden, Germany, 1307
    - University Hospital Dresden
  - Duisburg, Germany, 47055
    - MVZ Sanaklinikum Duisburg
  - Erlangen, Germany, 91054
    - Universitaetsklinik Erlangen
  - Essen, Germany, 45147
    - Universitaetsklinikum Essen
  - Frankfurt, Germany, 60590
    - JWG-University Hospital
  - Frankfurt am Main, Germany, 60431
    - Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
  - Freiburg im Breisgau, Germany, 79106
    - Universitatsklinikum Freiburg
  - Fulda, Germany, 36043
    - Klinikum Fulda - Tumorklinik - Germany
  - Haag, Germany, 83527
    - Curiositas ad sanum Studien und Beratungs GmbH
  - Halle, Germany, 6108
    - BSF Studiengesellschaft
  - Halle, Germany, 06120
    - Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
  - Hamburg, Germany, 20251
    - CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
  - Hanover, Germany, 30625
    - Medizinische Hochschule Hannover
  - Heidelberg, Germany, 69120
    - University Hospital Heidelberg
  - Heidelberg, Germany, 69115
    - Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
  - Jena, Germany, 07747
    - Universitatsklinikum Jena
  - Jerichow, Germany, 39319
    - Praxisgemeinschaft Jerichow
  - Karlshorst, Germany, 10318
    - Gastroenterologische Spezialpraxis - Berlin-Karlshorst
  - Kassel, Germany, 34117
    - Gastroenterologie Opernstrasse
  - Kiel, Germany, 24105
    - Universitatsklinikum Schleswig Holstein Kiel
  - Leipzig, Germany, 04103
    - Eugastro GmbH
  - Lüneburg, Germany, 21339
    - Staedtisches Klinikum Lueneburg
  - Mannheim, Germany, 68167
    - Medizinische Fakultät Mannheim der Universität Heidelberg
  - Minden, Germany, 32423
    - Gastroenterologische Gemeinschaftspraxis Minden
  - Munich, Germany, 81377
    - Klinikum der Universitaet Muenchen
  - Münster, Germany, 48149
    - Universitatsklinikum Munster
  - Münster, Germany, 48155
    - MVZ Portal 10
  - Nordhausen, Germany, 99734
    - Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
  - Nürtingen, Germany, 72622
    - Medius Klinik Nurtingen
  - Pforzheim, Germany, 75179
    - Siloah St Trudpert Klinikum
  - Regensburg, Germany, 93053
    - Universitaetsklinikum Regensburg
  - Rostock, Germany, 18057
    - Universitaetsmedizin Rostock
  - Saarbrücken, Germany, 66111
    - Zentrum für Gastroenterologie Saar MVZ GmbH
  - Tübingen, Germany, 72076
    - Universitatsklinikum Tubingen
  - Ulm, Germany, 89070
    - Universitatsklinikum Ulm
  - Würzburg, Germany, 97080
    - Universitatsklinikum Wurzburg
Greece
- - Athens, Greece, 115 27
    - Sotiria General State Hospital of Chest Diseases
  - Athens, Greece, 115 27
    - General Hospital of Athens 'Ippokrateion'
  - Thessaloniki, Greece, 54642
    - Hippokration Hospital
Hungary
- - Budapest, Hungary, 1036
    - Obudai Egeszsegugyi Centrum Kft
  - Budapest, Hungary, 1082
    - Semmelweis Egyetem
  - Budapest, Hungary, 1088
    - Semmelweis Egyetem I.Belgyogyaszati Klinika
  - Gyöngyös, Hungary, 3200
    - Bugat Pal Korhaz
  - Szeged, Hungary, H-6720
    - Szegedi Tudomanyegyetem
  - Szombathely, Hungary, H-9700
    - Markusovszky Egyetemi Oktatokorhaz
India
- - Ahmedabad, India, 380009
    - ICON Hospital Orchid Medi services and Research Private Limited
  - Bengaluru, India, 560054
    - M S Ramaiah Medical College and Hospital
  - Bhubaneswar, India, 751030
    - Siksha O Anusandhan University - Institute of Medical Scienc
  - Chennai, India, 600026
    - Srm Institutes For Medical Science (Sims)
  - Gurugram, India, 122002
    - Fortis Memorial Research Institute
  - Hyderabad, India, 500082
    - Asian Institute Of Gastroenterology
  - Hyderabad, India, 500082
    - Yashoda Super Speciality Hospitals 1
  - Mumbai, India, 400016
    - P D Hinduja National Hospital and Medical Research Center
  - New Delhi, India, 110029
    - All India Institute of Medical Sciences
  - Secunderabad, India, 500003
    - Yashoda Super Speciality Hospitals
  - Surat, India, 395002
    - Surat Institute of Digestive Sciences Hospitals
  - Surat, India, 395009
    - Gujarat Gastro and Vascular Hospital
Israel
- - Afula, Israel, 1834111
    - Haemek Medical Center - Afula
  - Haifa, Israel, 31096
    - Rambam Medical Center
  - Haifa, Israel, 31048
    - Bnai Zion Medical Center
  - Jerusalem, Israel, 9103102
    - Shaare Zedek Medical Center
  - Jerusalem, Israel, 91120
    - Hadassah Hebrew University Medical Center
  - Petah Tikva, Israel, 4941492
    - Rabin Med Ctr Beilinson Hosp
  - Rehovot, Israel, 76100
    - Kaplan Medical Center
  - Tel Aviv, Israel, 6423906
    - Tel Aviv Sourasky Medical Center
  - Tel Litwinsky, Israel, 52621
    - The Chaim Sheba Medical Center
  - Tzrifin, Israel, 70300
    - Assaf Harofeh Medical Center
Italy
- - Bari, Italy, 70124
    - Università degli Studi di Bari
  - Catania, Italy, 95126
    - A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
  - Messina, Italy, 98125
    - AOU Policlinico G.Martino
  - Milan, Italy, 20132
    - Ospedale San Raffaele
  - Monopoli, Italy, 70043
    - Ospedale Specializzato in Gastroenterologia Saverio de Bellis
  - Monserrato, Italy, 09042
    - Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
  - Monza, Italy, 20090
    - Azienda Ospedaliera San Gerardo
  - Negrar ( Ve), Italy, 37024
    - Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
  - Palermo, Italy, 90146
    - Ospedale Villa Sofia-Cervello
  - Roma, Italy, 00168
    - Catholic University of Sacred Hearth
  - Rozzano, Italy, 20089
    - IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
  - Torino, Italy, 10126
    - Ospedale Molinette, AO Città della Salute e della Scienza di
Japan
- - Asahikawa, Japan, 078-8510
    - Asahikawa Medical University Hospital
  - Bunkyō City, Japan, 113 8519
    - Tokyo Medical and Dental University Hospital
  - Chikushino-shi, Japan, 818-8502
    - Fukuoka University Chikushi Hospital
  - Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital
  - Fukuoka, Japan, 807-8555
    - Hospital of the University of Occupational and Environmental Health
  - Hachiōji, Japan, 192-0032
    - Tokai University Hachioji Hospital
  - Hamamatsu, Japan, 431-3192
    - Hamamatsu University Hospital
  - Hirosaki, Japan, 036-8563
    - Hirosaki University Hospital
  - Hirosaki, Japan, 036-8545
    - National Hospital Organization Hirosaki General Medical Center
  - Hitachi, Japan, 317-0077
    - Hitachi General Hospital
  - Hyōgo, Japan, 663-8501
    - Hyogo Medical University Hospital
  - Kagoshima, Japan, 890-8520
    - Kagoshima University Hospital
  - Kagoshima, Japan, 892-0843
    - Kagoshima IBD Gastroenterology Clinic
  - Kamakura, Japan, 247-0056
    - Ofuna Chuo Hospital
  - Kanazawa, Japan, 9208641
    - Kanazawa University Hospital
  - Kashiwa, Japan, 277-0871
    - Tsujinaka Hospital Kashiwanoha
  - Kawagoe, Japan, 350-8550
    - Saitama Medical University Saitama Medical Center
  - Kitakyushu, Japan, 800-0296
    - Kyushu Rosai Hospital
  - Kobe, Japan, 650-0017
    - Kobe University Hospital
  - Kumamoto, Japan, 861-8520
    - Japanese Red Cross Kumamoto Hospital
  - Kurume, Japan, 830-0011
    - Kurume University Hospital
  - Kyoto, Japan, 602-8566
    - University Hospital Kyoto Prefectural University of Medicine
  - Mitaka, Japan, 181-8611
    - Kyorin University Hospital
  - Morioka, Japan, 020-8505
    - Iwate Medical University Hospital
  - Nagaoka, Japan, 940-2085
    - Nagaoka Red Cross Hospital
  - Nagasaki, Japan, 852-8501
    - Nagasaki University Hospital
  - Nagoya, Japan, 466 8560
    - Nagoya University Hospital
  - Niigata, Japan, 951-8520
    - Niigata University Medical And Dental Hospital
  - Okayama, Japan, 700-8558
    - Okayama University Hospital
  - Osaka, Japan, 545-8586
    - Osaka City University Hospital
  - Osaka, Japan, 553-0003
    - Japan Community Health Care Organization Osaka Hospital
  - Osaka, Japan, 530-0011
    - Kinshukai Infusion Clinic
  - Saga, Japan, 849-0937
    - Saga University Hospital
  - Saitama, Japan, 336-0963
    - Tokitokai Tokito Clinic Coloproctology Center
  - Sakura, Japan, 285-8741
    - Toho University Sakura Medical Center
  - Sapporo, Japan, 065-0033
    - Sapporo Higashi Tokushukai Hospital
  - Sapporo, Japan, 004-0041
    - Sapporo Tokushukai Hospital
  - Sapporo, Japan, 060-0033
    - Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  - Sapporo, Japan, 060-8556
    - Sapporo Medical University Hospital
  - Sendai, Japan, 980-8574
    - Tohoku University Hospital
  - Shimotsuga-gun, Japan, 321-0293
    - Dokkyo Medical University Hospital
  - Shimotsuke, Japan, 329-0498
    - Jichi Medical University Hospital
  - Shinjuku Ku, Japan, 162 8655
    - Center Hospital of the National Center for Global Health and Medicine
  - Shinjuku-Ku, Japan, 162-8666
    - Tokyo Women's Medical University Hospital
  - Sumida Ku, Japan, 130 8575
    - Tokyo Metropolitan Bokutoh Hospital
  - Takamatsu, Japan, 760-0017
    - Takamatsu Red Cross Hospital
  - Tokyo, Japan, 108-8642
    - Kitasato University Kitasato Institute Hospital
  - Tokyo, Japan, 105 8471
    - The Jikei University Hospital
  - Toyama, Japan, 9308550
    - Toyama Prefectural Central Hospital
  - Toyota, Japan, 470-1219
    - Ieda Hospital
  - Tsu, Japan, 514-8507
    - Mie University Hospital
  - Yokohama, Japan, 232 0024
    - Yokohama City University Medical Center
  - Ōtsu, Japan, 520-2192
    - Shiga University of Medical Science Hospital
Jordan
- - Amman, Jordan, 11942
    - Jordan University Hospital
  - Amman, Jordan
    - Abdali Hospital
  - Irbid, Jordan, 22110
    - King Abdullah University Hospital
  - Irbid, Jordan, 21110
    - Irbid Specialty Hospital
Malaysia
- - Alor Star, Malaysia, 5460
    - Hospital Sultanah Bahiyah
  - Ampang, Malaysia, 68000
    - Hospital Ampang
  - George Town, Malaysia, 10990
    - Hospital Pulau Pinang
  - Kuala Lumpur, Malaysia, 59100
    - University Malaya Medical Centre
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academisch Medisch Centrum Universiteit van Amsterdam
  - Dordrecht, Netherlands, 3318 AT
    - Albert Schweitzer Ziekenhuis
  - Leiden, Netherlands, 2333 ZA
    - Leiden University Medical Center
  - Maastricht, Netherlands, 6229 HX
    - Maastricht Universitair Medisch Centrum
  - Rotterdam, Netherlands, 3015 GD
    - Erasmus MC
  - Utrecht, Netherlands, 3508 GA
    - UMC Utrecht
New Zealand
- - Dunedin, New Zealand, 9016
    - Dunedin Hospital
  - Lower Hutt, New Zealand, 5010
    - Hutt Hospital
  - Wellington, New Zealand, 6021
    - Wellington Hospital
Norway
- - Gjettum, Norway, 1346
    - Vestre Viken HF Baerum Sykehus
  - Lørenskog, Norway, 1478
    - Akershus Universitetssykehus
  - Oslo, Norway, 0450
    - Oslo University Hospital HF Ulleval sykehus
  - Tromsø, Norway, N-9038
    - Universitetssykehuset Nord-Norge HF
  - Ålesund, Norway, 6010
    - Alesund sjukehus
Poland
- - Bydgoszcz, Poland, 85-168
    - Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
  - Krakow, Poland, 31-513
    - Centrum Medyczne Promed
  - Krakow, Poland, 30 363
    - Centrum Medyczne Plejady
  - Lodz, Poland, 90-644
    - AmiCare Centrum Medyczne
  - Lublin, Poland, 20-583
    - Gastromed ZOZ
  - Olsztyn, Poland, 10 561
    - Wojewodzki Szpital Specjalistyczny w Olsztynie
  - Poznan, Poland, 61-293
    - Twoja Przychodnia
  - Poznan, Poland, 61 441
    - Synexus Polska Sp z o o
  - Rzeszów, Poland, 35-326
    - Centrum Medyczne MEDYK
  - Sopot, Poland, 81-756
    - Endoskopia Sp z o.o.
  - Szczecin, Poland, 71-685
    - Sonomed Sp. z o.o.
  - Torun, Poland, 87 100
    - GASTROMED Sp. z o.o.
  - Warsaw, Poland, 02 507
    - Centralny Szpital Kliniczny Mswia
  - Warsaw, Poland, 00 632
    - Centrum Zdrowia Matki Dziecka i Mlodziezy
  - Warsaw, Poland, 03 580
    - NZOZ Vivamed
  - Warsaw, Poland, 03 712
    - Bodyclinic Sp. z o.o. sp. k
  - Warsaw, Poland, 02-655
    - Reumatika-Centrum Reumatologii, NZOZ
  - Wroclaw, Poland, 52-416
    - Centrum Medyczne Oporow
  - Wroclaw, Poland, 50 449
    - Melita Medical Sp. z o.o.
  - Włocławek, Poland, 87-800
    - Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
  - Zamość, Poland, 22-400
    - ETG Zamosc
Portugal
- - Lisbon, Portugal, 1649-035
    - Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
  - Portimão, Portugal, 8500-338
    - Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
  - Porto, Portugal, 4434-502
    - Centro Hospitalar Vila Nova de Gaia
  - Santa Maria da Feira, Portugal, 4520-211
    - Centro Hospitalar de Entre o Douro e Vouga, E.P.E
Singapore
- - Singapore, Singapore, 169608
    - Singapore General Hospital
  - Singapore, Singapore, 308433
    - Tan Tock Seng Hospital
  - Singapore, Singapore, 228510
    - KL Ling Gastroenterology and Liver Clinic
  - Singapore, Singapore, 258499
    - Gi Associates Gastroenterology
Slovenia
- - Celje, Slovenia, 3000
    - Splosna bolnisnica Celje
  - Ljubljana, Slovenia, 1000
    - Univerzitetni klinicni center Ljubljana
South Africa
- - Benoni, South Africa, 1501
    - Worthwhile Clinical Trials Lakeview Hospital
  - Cape Town, South Africa, 7925
    - Clinical Research Centre University of Cape Town
  - Cape Town, South Africa, 7925
    - Groote Schur Hospital
  - Cape Town, South Africa, 7500
    - Mediclinic Panorama
  - Cape Town, South Africa, 7800
    - Inspired GI Care
  - Durban, South Africa, 3610
    - Hillcrest private
South Korea
- - Busan, South Korea, 48108
    - Inje University Haeundae Paik Hospital
  - Busan, South Korea, 48108
    - Kosin University Gospel Hospital
  - Daegu, South Korea, 41944
    - Kyungpook National University Hospital
  - Daegu, South Korea, 42415
    - Yeungnam University Hospital
  - Goyang-si, South Korea, 10326
    - Dongguk University Ilsan Hospital
  - Gwangju, South Korea, 61453
    - Chosun university hospital
  - Hwaseong-si, South Korea, 18450
    - Hallym University Dongtan Sacred Heart Hospital
  - Seongnam-si, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 05505
    - Asan Medical Center
  - Seoul, South Korea, 03722
    - Severance Hospital Yonsei University Health System
  - Seoul, South Korea, 03181
    - Kangbuk Samsung Hospital
  - Seoul, South Korea, 06273
    - Gangnam Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, 130 050
    - Kyung Hee University Hospital
  - Seoul, South Korea, 06591
    - The Catholic University of Korea Seoul St.Mary's Hospital
  - Seoul, South Korea, 6591
    - The Catholic University of Korea Seoul St.Marys Hospital 1
  - Suwon, South Korea, 16499
    - Ajou University Hospital
  - Suwon, South Korea, 16247
    - The Catholic University of Korea
Spain
- - Madrid, Spain, 28046
    - Hosp. Univ. La Paz
  - Pamplona, Spain, 31008
    - Hosp. de Navarra
  - Pontevedra, Spain, 36071
    - Hosp. Montecelo
  - Sabadell, Spain, 8208
    - Corporacio Sanitari Parc Tauli
  - Santander, Spain, 39008
    - Hosp. Univ. Marques de Valdecilla
  - Torrejón de Ardoz, Spain, 28850
    - Hosp. Univ. de Torrejon
Sweden
- - Solna, Sweden, 17176
    - Karolinska University Hospital
  - Stockholm, Sweden, 116 91
    - Ersta sjukhus
  - Örebro, Sweden, 70185
    - Universitetssjukhuset Orebro
Switzerland
- - Basel, Switzerland, 4056
    - Universitatsspital Basel
  - Bern, Switzerland, 3010
    - INSELSPITAL Universitätsspital Bern
  - Bern, Switzerland, 3012
    - Gastroenterologische Praxis Balsiger und Seibold
  - Sankt Gallen, Switzerland, 9007
    - Kantonsspital St Gallen
  - Zurich, Switzerland, 8091
    - UniversitaetsSpital Zuerich
Taiwan
- - Changhua, Taiwan, 500
    - Chang-Hua Christian Hospital
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Tainan, Taiwan, 70403
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
United Kingdom
- - Belfast, United Kingdom, BT12 6BA
    - Royal Victoria Hospital
  - Birmingham, United Kingdom, B15 2TH
    - University Hospitals Birmingham NHS Foundation Trust
  - Cambridge, United Kingdom, CB2 0QQ
    - Addenbrooke's Hospital
  - Glasgow, United Kingdom, G4 0SF
    - Glasgow Royal Infirmary
  - Glasgow, United Kingdom, G51 4TF
    - Queen Elizabeth University Hospital
  - High Wycombe, United Kingdom, HP112QW
    - Velocity Clinical Research
  - London, United Kingdom, E111NR
    - Whipps Cross University Hospital
  - London, United Kingdom, SW19 0QT
    - St Georges Healthcare NHS Trust
  - Oxford, United Kingdom, OX3 9DU
    - John Radcliffe Hospital
  - Wolverhampton, United Kingdom, WV10 0QP
    - New Cross Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama Liver Center
- Arizona
  - Tucson, Arizona, United States, 85715
    - Del Sol Research Management, LLC
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Moore Clinical Trials, LLC
- California
  - Apple Valley, California, United States, 92307
    - Om Research LLC
  - Arcadia, California, United States, 91006
    - Valley Gastroenterology Medical Group
  - Coronado, California, United States, 92118
    - Southern California Research Center
  - Lancaster, California, United States, 93534
    - Desert Gastroenterology Associates
  - Los Angeles, California, United States, 90095
    - UCLA
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Newport Beach, California, United States, 92658
    - Hoag Memorial Hospital
  - Orange, California, United States, 92868
    - UCI Irvine Medical Center
  - San Diego, California, United States, 92123
    - Medical Associates Research Group, Inc.
  - San Francisco, California, United States, 94115
    - University of California San Francisco
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - Medical Research Center of Connecticut
  - New Haven, Connecticut, United States, 06510
    - Yale University School Of Medicine
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - MedStar Georgetown University Hospital
- Florida
  - Coconut Creek, Florida, United States, 33066
    - Pioneer Research Solutions Inc.
  - Homestead, Florida, United States, 33032
    - Homestead Associates in Research Inc
  - Kissimmee, Florida, United States, 34741
    - Osceola Mental Health D/B/A Park Place Behavioral Health Care
  - Lakewood Rch, Florida, United States, 34211
    - Florida Research Center Inc.
  - Miami, Florida, United States, 33136
    - University of Miami Hospital
  - Naples, Florida, United States, 34102
    - Gastroenterology Group Of Naples
  - Orlando, Florida, United States, 32808
    - Omega Research Consultants
  - St. Petersburg, Florida, United States, 33705
    - Synergy Clinical Research
  - Tampa, Florida, United States, 33609
    - GCP Clinical Research
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates
  - Atlanta, Georgia, United States, 30342
    - University of Mississippi Medical Center
  - Macon, Georgia, United States, 31201
    - Gastroenterolgy Associates of Central GA
  - Marietta, Georgia, United States, 30060
    - Gastrointestinal Specialists of Georgia
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - IU Health University Hospital
  - New Albany, Indiana, United States, 47150
    - Gastroenterology of Southern Indiana
- Kansas
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Digestive Health Center
  - Wichita, Kansas, United States, 67208
    - Ascension via Christi Research
  - Wichita, Kansas, United States, 67214-3124
    - Univ. of KS School of Med
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Tri-State Gastroenterology Assoc
  - Lexington, Kentucky, United States, 40536
    - University Of Kentucky
  - Louisville, Kentucky, United States, 40202
    - Jewish Hospital
- Louisiana
  - Lafayette, Louisiana, United States, 70503
    - Gastroenterology Clinic of Acadiana
  - Marrero, Louisiana, United States, 70072
    - Tandem Clinical Research
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - Chevy Chase Clinical Research
- Massachusetts
  - Boston, Massachusetts, United States, 02215-5400
    - Lahey Hospital & Medical Center
  - Chestnut Hill, Massachusetts, United States, 02467
    - Brigham and Women's Hospital
  - South Dartmouth, Massachusetts, United States, 02747
    - FC Research, LLC
- Michigan
  - Livonia, Michigan, United States, 48152
    - Detroit Clinical Research Center
  - Ypsilanti, Michigan, United States, 48197
    - Huron Gastroenterology Associates Center for Digestive Care
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Gastrointestinal Associates LLP
- Missouri
  - St Louis, Missouri, United States, 63110
    - Washington University
- Nevada
  - Las Vegas, Nevada, United States, 89113
    - Las Vegas Medical Research
  - Las Vegas, Nevada, United States, 89148
    - Care Access Las Vegas
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock
- New York
  - Great Neck, New York, United States, 11021
    - Northwell Health
  - Jackson Heights, New York, United States, 11372
    - A1 Clinical Research
  - New York, New York, United States, 10021
    - Weill Cornell Medical College
  - New York, New York, United States, 10075
    - Lenox Hill Hospital
  - Utica, New York, United States, 13502-6313
    - Mohawk Valley Endoscopy Center
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7080
    - University of North Carolina
  - Charlotte, North Carolina, United States, 28210
    - Tryon Medical Group
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston-Salem
- Ohio
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Case Medical Center
  - Cleveland, Ohio, United States, 44195-6501
    - Cleveland Clinic
  - Westlake, Ohio, United States, 44145
    - Northshore Gastroenterology Research, LLC
- Oregon
  - Portland, Oregon, United States, 97220-9428
    - The Oregon Clinic
- Pennsylvania
  - Harrisburg, Pennsylvania, United States, 17110-3673
    - Susquehanna Gastroenterology Associates
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania - Perelman School of Medicine
  - Smithfield, Pennsylvania, United States, 15478
    - Frontier Clinical Research
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Rock Hill, South Carolina, United States, 29732
    - Digestive Disease Associates
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Saint Francis Hospital
  - Hixson, Tennessee, United States, 37343
    - Galen Medical Group
  - Johnson City, Tennessee, United States, 37604
    - Etsu Quillen College Of Medicine
  - Nashville, Tennessee, United States, 37067
    - Vanderbilt University Medical Center
- Texas
  - Austin, Texas, United States, 78750
    - Amel Med LLC Research
  - Dallas, Texas, United States, 75390-9063
    - UT Southwestern Medical Center
  - Dallas, Texas, United States, 75242
    - Baylor University Medical Center
  - Houston, Texas, United States, 77034
    - Accurate Clinical Research
  - San Antonio, Texas, United States, 78229
    - Gastroenterology Clinic Of San Antonio P A
  - Southlake, Texas, United States, 76092
    - Texas Digestive Disease Consultants
  - Tyler, Texas, United States, 75701
    - Digestive Health Specialists
- Utah
  - Ogden, Utah, United States, 84403
    - Care Access Research, Ogden
  - Salt Lake City, Utah, United States, 84124
    - Care Access Research- Salt Lake City
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes McGuire Veterans Affairs Medical Center
- Washington
  - Bellevue, Washington, United States, 98004
    - Washington Gastroenterology, PLLC
  - Seattle, Washington, United States, 98104
    - Swedish Medical Center
  - Seattle, Washington, United States, 98195
    - University of Washington Digestive Disease Center
  - Tacoma, Washington, United States, 98405
    - Digestive Health Specialists 1
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Marshall Health Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
Confirmed diagnosis of moderate to severe CD as assessed by Crohn'

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1: Placebo Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Drug: Placebo Placebo will be administered as subcutaneous injection.
Experimental: Group 2: Guselkumab Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: Guselkumab Guselkumab will be administered as subcutaneous injection.
Experimental: Group 3: Golimumab Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: Golimumab Golimumab will be administered as subcutaneous injection.
Experimental: Group 4: JNJ-78934804 (High-dose) Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
Experimental: Group 5: JNJ-78934804 (Mid-dose) Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.
Experimental: Group 6: JNJ-78934804 (Low-dose) Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: JNJ-78934804 JNJ-78934804 will be administered subcutaneously as per defined regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Clinical Remission at Week 48 Time Frame: Week 48	Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).	Week 48
Percentage of Participants with Endoscopic Response at Week 48 Time Frame: Week 48	Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the simple endoscopic score for Crohn's disease (SES-CD), as assessed by central endoscopy reading.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48 Time Frame: Week 48	Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.	Week 48
Percentage of Participants with Adverse Events (AEs) Time Frame: Up to Week 48	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.	Up to Week 48
Percentage of Participants with Serious Adverse Events (SAEs) Time Frame: Up to Week 48	A 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; is medically important.	Up to Week 48
Serum Concentrations of Guselkumab Over Time Time Frame: Up to Week 48	Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.	Up to Week 48
Serum Concentrations of Golimumab Over Time Time Frame: Up to Week 48	Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.	Up to Week 48
Percentage of Participants with Antibodies to Guselkumab Time Frame: Up to Week 48	Percentage of participants with antibodies to guselkumab will be reported.	Up to Week 48
Titers of Antibodies to Guselkumab Time Frame: Up to Week 48	Titers of antibodies to guselkumab will be reported.	Up to Week 48
Percentage of Participants with Antibodies to Golimumab Time Frame: Up to Week 48	Percentage of participants with antibodies to golimumab will be reported.	Up to Week 48
Titers of Antibodies to Golimumab Time Frame: Up to Week 48	Titers of antibodies to golimumab will be reported.	Up to Week 48
Percentage of Participants with Neutralizing Antibodies to Guselkumab. Time Frame: Up to Week 48	Percentage of participants with neutralizing antibodies to guselkumab will be reported.	Up to Week 48
Percentage of Participants with Neutralizing Antibodies to Golimumab Time Frame: Up to Week 48	Percentage of participants with neutralizing antibodies to golimumab will be reported.	Up to Week 48
Percentage of Participants with Endoscopic Remission at Week 48 Time Frame: Week 48	Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD, as assessed by central endoscopy reading.	Week 48
Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48 Time Frame: Week 48	Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.	Week 48
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48 Time Frame: Week 48	Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).	Week 48
Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48 Time Frame: Week 48	Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the SES-CD, as assessed by central endoscopy reading.	Week 48
Clinical Laboratory Parameters Over Time Time Frame: Up to Week 48	Clinical laboratory parameters over time will be reported.	Up to Week 48
Vital Sign Parameters Over Time Time Frame: Up to Week 48	Vital sign parameters over time will be reported.	Up to Week 48
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score Time Frame: Up to Week 48	The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation is defined as an increase in severity of suicidal ideation from baseline.	Up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Actual)

May 23, 2025

Study Completion (Estimated)

November 5, 2029

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CR109178
2021-003314-39 (EudraCT Number)
78934804CRD2001 (Other Identifier: Janssen Research & Development, LLC)
2023-504741-32-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

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product manufactured in and exported from the U.S.

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