A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (DUET-UC)

May 14, 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 Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

577

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

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1119ACN
        • CIPREC
      • Ciudad Autonoma Buenos Aires, Argentina, C1264AAN
        • Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo
      • Córdoba, Argentina, X5002AOQ
        • Sanatorio Duarte Quiroz
      • Mar del Plata, Argentina, B7600FYK
        • Centro de Investigaciones Medicas Mar Del Plata
      • Rosario, Argentina, 2002
        • Hospital Provincial del Centenario
  • Australia
      • Box Hill, Australia, 3128
        • Box Hill Hospital
      • Camperdown, Australia, 2050
        • Royal Prince Alfred Hospital
      • Clayton, Australia, 3168
        • Monash Health, Monash Medical Centre
      • Concord, Australia, 2139
        • Concord Hospital
      • Footscray, Australia, 3011
        • Western Health
      • Maroochydore, Australia, 4558
        • Coastal Digestive Health
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
      • North Terrace, Australia, 5000
        • Royal Adelaide Hospital
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital
      • Prahran, Australia, 3004
        • The Alfred Hospital
      • South Brisbane, Australia, 4101
        • Mater Hospital Brisbane
  • Austria
      • Salzburg, Austria, 5020
        • Universitaetsklinikum Salzburg Landeskrankenhaus
      • Vienna, Austria, 1020
        • Krankenhaus der Barmherzigen Brüder
      • Vienna, Austria, 1090
        • Medizinische Universitaet Wien
      • Wels, Austria, 4600
        • Klinikum Wels Grieskirchen
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis
      • Bruges, Belgium, 8000
        • Algemeen Ziekenhuis Sint-Jan
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
      • Ghent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liege
      • Liège, Belgium, 4000
        • CHC MontLegia
      • Sint-Niklaas, Belgium
        • Vitaz
  • Brazil
      • Botucatu, Brazil, 18618-970
        • Universidade Estadual Paulista 'Julio De Mesquita Filho'
      • Brasília, Brazil, 70200-730
        • L2IP Instituto de Pesquisas Clinicas
      • Brasília, Brazil, 72145-450
        • Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
      • Caxias do Sul, Brazil, 95070-560
        • Fundacao Universidade de Caxias do Sul
      • Curitiba, Brazil, 80430-180
        • Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
      • Porto Alegre, Brazil, 90035-903
        • Hospital das Clinicas de Porto Alegre
      • Porto Alegre, Brazil, 90035-003
        • Hospital De Clinicas De Porto Alegre
      • Porto Alegre, Brazil, 90035-001
        • Associacao Hospitalar Moinhos de Vento
      • Rio de Janeiro, Brazil, 21941-913
        • Universidade Federal do Rio de Janeiro - Faculdade de Medicina
      • Salvador, Brazil, 40150 150
        • SER - Servicos Especializados em Reumatologia da Bahia
      • Santo André, Brazil, 09080-110
        • Pesquisare Saude
      • Santos, Brazil, 11075-101
        • Irmandade da Santa Casa da Misericórdia de Santos
      • São Paulo, Brazil, 03325-050
        • BR Trials
      • 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, 01409 902
        • Hospital Nove de Julho
  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Medical Centre Hipocrat
      • Sliven, Bulgaria, 8800
        • Diagnostic Consulting Center I Sliven
      • Sofia, Bulgaria, 1527
        • UMHAT 'Tsaritsa Yoanna'
      • Sofia-Grad, Bulgaria, 1431
        • University Hospital Alexandrovska - Clinic of Nephrology
      • Veliko Tarnovo, Bulgaria, 5000
        • Medical Center -Medika Plus
      • Vratsa, Bulgaria, 3000
        • Multriprofile Hospital for Active Treatment Hristo Botev
  • Canada
      • Bridgewater, Canada, B4V 3N2
        • Viable Clinical Research
      • Saguenay, Canada, G7H3C3
        • Hopital Chicoutimi
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Hospital
      • Edmonton, Alberta, Canada, T5R 1W2
        • Gastroenterology and Internal Medicine Research Institute (GIRI)
      • Edmonton, Alberta, Canada, T6L 6K3
        • Covenant Health/Grey Nuns hospital
    • British Columbia
      • New Westminster, British Columbia, Canada
        • Columbia Gastroenterology
      • 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
        • 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
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Campus
      • 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
      • Mount Royal, Quebec, Canada, H3P 3E5
        • CMIIM, Centre médical L'Enjeu
      • Saint-Jérôme, Quebec, Canada, V8R 4R2
        • St. Jerome Medical Research
  • Chile
      • Concepción, Chile, 4030000
        • Hospital Clinico Regional Dr. Guillermo Grant Benavente
      • Santiago, Chile, 8331143
        • Centro de Estudios Clínicos e Investigación Médica (CeCim)
      • Santiago, Chile, 7640881
        • Clinica Dermacross S A
      • Santiago, Chile, 8207257
        • Complejo Asistencial Hospital Dr. Sótero del Río
  • China
      • Chaoyang, China, 100013
        • China Japan Friendship Hospital
      • Chengdu, China, 610041
        • West China Hospital Sichuan University
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Jinhua, China, 321000
        • Jinhua municipal central hospital
      • Nanjing, China, 210009
        • Zhongda Hospital Southeast University
      • Wuhan, China, 430022
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • 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.
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Hospital
      • 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
  • Estonia
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital
      • Tartu, Estonia, 51014
        • Tartu University Hospital
  • France
      • Amiens, France, 80054
        • CHU Amiens - Hopital Sud
      • Colombes, France, 92701
        • Hôpital Louis Mourier
      • Créteil, France, 94010
        • Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
      • Grenoble, France, 38700
        • CHU Grenoble
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Departemental Vendee
      • Lille, France, 59037
        • CHRU de Lille Hopital Claude Huriez
      • Marseille, France, 13915
        • Hopital Nord Marseille
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Neuilly-sur-Seine, France, 92200
        • Clinique Ambroise Pare
      • Nice, France, 06202
        • CHU de Nice Hopital de l Archet
      • Nîmes, France, 30029
        • CHU Nimes Hopital Caremeau
      • Pessac, France, 33604
        • Hopital Haut-Leveque, CMC Magellan
      • Pierre-Bénite, France, 69495
        • Hospices Civils de Lyon HCL
      • Saint-Etienne, France, 42270
        • CHU Saint Etienne
      • Toulouse, France, 31059
        • Hopital de Rangueil
      • Vandœuvre-lès-Nancy, France, 54511
        • CHRU Nancy Brabois
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
      • Berlin, Germany, 14163
        • Krankenhaus Waldfriede Mitte
      • Berlin, Germany, 12203
        • Charite - Universitaetsmedizin Berlin (CCM)
      • Berlin, Germany, 10825
        • Praxis Fur Gastroenteroligie
      • Dresden, Germany, 1307
        • University Hospital Dresden
      • Erlangen, Germany, 91054
        • Universitaetsklinik Erlangen
      • Frankfurt, Germany, 69590
        • 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
      • Halle, Germany, 06108
        • BSF Studiengesellschaft
      • Halle, Germany, 06097
        • Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
      • 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
      • Leipzig, Germany, 04103
        • Eugastro GmbH
      • Lüneburg, Germany, 21339
        • Staedtisches Klinikum Lueneburg
      • Mannheim, Germany, 68167
        • Universitaetsklinikum Mannheim
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Munich, Germany, 81377
        • Klinikum der Universitaet Muenchen
      • Münster, Germany, 48155
        • MVZ Portal 10
      • Münster, Germany, 48149
        • Praxis fur Innere Medizin und Gastroenterologie
      • Nürtingen, Germany, 72622
        • Medius Klinik Nurtingen
      • Pforzheim, Germany, 75179
        • Siloah St Trudpert Klinikum
      • Saarbrücken, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH
      • Tübingen, Germany, 72076
        • Universitaetsklinik Tuebingen
      • Ulm, Germany, 89070
        • Universitatsklinikum Ulm
      • Wipperfürth, Germany, 51688
        • Gemeinschaftspraxis Jakobeit
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg
  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital of Athens
      • Athens, Greece, 115 27
        • Sotiria General State Hospital of Chest Diseases
      • Piraeus, Greece, 184 54
        • Nikaia General Hospital
      • Thessaloniki, Greece, 54642
        • Hippokration Hospital
  • Hungary
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Budapest, Hungary, 1062
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest, Hungary, H-1088
        • Semmelweis Egyetem
      • Budapest, Hungary, H-1136
        • Pannónia Magánorvosi Centrum Kft
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz
      • Szeged, Hungary, 6720
        • Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
      • Szombathely, Hungary, H-9700
        • Markusovszky Egyetemi Oktatokorhaz
  • India
      • Bangalore, India, 560054
        • M S Ramaiah Medical College and Hospital
      • Bhubaneswar, India, 751003
        • Siksha O Anusandhan University - Institute of Medical Scienc
      • Jaipur, India, 302017
        • Apex Hospitals Ltd
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110088
        • Fortis Hospital
      • New Delhi, India, 110 002
        • G.B. Pant Hospital
      • Secunderabad, India, 500003
        • Yashoda Super Speciality Hospitals
      • Surat, India, 395002
        • Surat Institute of Digestive Sciences Hospitals
  • Israel
      • Afula, Israel, 1834111
        • Haemek Medical Center - Afula
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center Beilinson Campus
      • 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 HSR Istituto Scientifico Universitario San Raffaele
      • Monserrato, Italy, 09042
        • Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
      • Monza, Italy, 20090
        • Azienda Ospedaliera San Gerardo
      • Negrar, Italy, 37024
        • Ospedale Sacro Cuore Don Calabria
      • Palermo, Italy, 90146
        • Ospedale Villa Sofia-Cervello
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00128
        • Università Campus Biomedico di Roma
      • Rozzano, Italy, 20089
        • IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
      • San Giovanni Rotondo, Italy, 71013
        • Casa Sollievo della Sofferenza
  • 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-ken, Japan, 802-0077
        • Kitakyushu Municipal Medical Center
      • Gifu, Japan, 500-8717
        • Gifu Prefectural General Medical Center
      • 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
      • Isehara, Japan, 259-1193
        • Tokai University Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kagoshima, Japan, 892-0843
        • Kagoshima IBD Gastroenterology Clinic
      • Kamakura, Japan, 247-0056
        • Ofuna Chuo Hospital
      • Kanagawa, Japan, 220-0045
        • Matsushima Clinic
      • Kashihara, Japan, 634-8522
        • Nara Medical University Hospital
      • Kashiwa, Japan, 277-0871
        • Tsujinaka Hospital Kashiwanoha
      • Kobe, Japan, 650-0017
        • Kobe University Hospital
      • Kofu, Japan, 400-0027
        • Yamanashi Prefectural Central Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Kyoto, Japan, 606 8507
        • Kyoto University Hospital
      • Maebashi, Japan, 371-8511
        • Gunma University Hospital
      • Minatoku, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Mitaka, Japan, 181-8611
        • Kyorin University Hospital
      • Morioka, Japan, 112-0015
        • Iwate Medical University Hospital
      • Nagoya, Japan, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Japan, 466 8560
        • Nagoya University Hospital
      • Nishinomiya, Japan, 663-8501
        • The Hospital of Hyogo College of Medicine
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National 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
      • 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 Chuo-ku, Japan, 064-0919
        • Sapporo IBD Clinic
      • Sumida Ku, Japan, 130 8575
        • Tokyo Metropolitan Bokutoh Hospital
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 108-0073
        • Tokyo Saiseikai Central Hospital
      • Tokyo, Japan, 105 8471
        • The Jikei University Hospital
      • Tokyo, Japan, 152 8902
        • National Hospital Organization Tokyo Medical Center
      • Tomakomai, Japan, 053-8506
        • Oji General Hospital
      • Toyama, Japan, 930 8550
        • Toyama Prefectural Central Hospital
      • Toyota, Japan, 470-0396
        • Toyota Kosei Hospital
      • Tsu, Japan, 514-8507
        • Mie University Hospital
      • Tsukuba, Japan, 305 8576
        • University of Tsukuba Hospital
      • Wakayama, Japan, 641 8510
        • Wakayama Medical University Hospital
      • Yokohama, Japan, 232 0024
        • Yokohama City University Medical Center
      • Ōgaki, Japan, 503-8502
        • Ogaki Municipal Hospital
      • Ōita, Japan, 870-0033
        • Oita Red Cross Hospital
  • Jordan
      • Amman, Jordan, 11942
        • Jordan University Hospital
      • Amman, Jordan, 11184
        • Istishari Hospital
      • Irbid, Jordan, 22110
        • King Abdullah University Hospital
      • Irbid, Jordan, 21110
        • Irbid Specialty Hospital
  • Netherlands
      • Amsterdam, Netherlands, 105 AZ
        • Academisch Medisch Centrum Universiteit van Amsterdam
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Centre
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
  • New Zealand
      • Christchurch, New Zealand, 8140
        • Christchurch Hospital
      • 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
      • Gjøvik, Norway, 2819
        • Sykehuset Innlandet HF Gjøvik
      • 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 No2
      • Krakow, Poland, 31-513
        • Centrum Medyczne Promed
      • Krakow, Poland, 30 363
        • Centrum Medyczne Plejady
      • Lodz, Poland, 90-644
        • AmiCare Centrum Medyczne
      • Lublin, Poland, 20-412
        • ETG Lublin
      • Lublin, Poland, 20-582
        • Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
      • Nowy Targ, Poland, 34 400
        • Allmedica
      • 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, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • 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, 54 144
        • EuroMediCare Szpital Specjalistyczny z Przychodnia
      • Wroclaw, Poland, 50 449
        • Melita Medical Sp. z o.o.
      • Wroclaw, Poland, 53 149
        • Przychodnia Vistamed
      • Wroclaw, Poland, 52 415
        • Centrum Medyczne Oporow
      • 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 de Lisboa Norte Hospital Santa Maria
      • Loures, Portugal, 2674 514
        • Uls Loures Odivelas - Hosp. Loures
      • Portimão, Portugal, 8500-338
        • Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre o Douro e Vouga, E.P.E
      • Vila Nova de Gaia, Portugal, 4434 502
        • Uls Gaia Espinho
  • Slovakia
      • Banská Bystrica, Slovakia, 974 01
        • FNsP F.D.R. Banska Bystrica
      • Bratislava, Slovakia, 811 09
        • Cliniq s.r.o.
      • Prešov, Slovakia, 080 01
        • GASTRO I. s.r.o.
      • Vranov nad Topľou, Slovakia, 093 01
        • Gastroenterology Department ENDOMED, s.r.o.
  • 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
        • Groote Schur Hospital
      • Cape Town, South Africa, 7500
        • Mediclinic Panorama
      • Johannesburg, South Africa, 1827
        • Practice Dr Naeem Moosa
      • Pretoria, South Africa, 0002
        • Emmed Research
  • South Korea
      • Busan, South Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, South Korea, 49267
        • Kosin University Gospel Hospital
      • Daegu, South Korea, 42415
        • Yeungnam University Hospital
      • Gwangju, South Korea, 61453
        • Chosun university hospital
      • Gyeonggi-do, South Korea, 16247
        • The Catholic university of Korea, St. Vincent's Hospital
      • Hwaseong-si, South Korea, 18450
        • Hallym University Dongtan Sacred Heart 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
      • Wŏnju, South Korea, 26426
        • Yonsei University Wonju Severance Christian Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • 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
      • Vigo, Spain, 36213
        • Hosp. Alvaro Cunqueiro
  • Sweden
      • Solna, Sweden, 171 76
        • Karolinska Universitetssjukhuset Solna
      • Stockholm, Sweden, 116 91
        • Ersta sjukhus
  • Switzerland
      • Basel, Switzerland, 4031
        • 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
        • Changhua Christian Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 407204
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital, Division of Infectious Diseases
      • Taoyuan, Taiwan, 33305
        • Chang-Gung Memorial Hospital, LinKou Branch
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • High Wycombe, United Kingdom, HP112QW
        • Velocity Clinical Research
      • London, United Kingdom, SW17 0QT
        • St Georges University Hospital NHS Foundation Trust
      • London, United Kingdom, SW109NH
        • Chelsea and Westminster Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • California
      • Arcadia, California, United States, 91006
        • Valley Gastroenterology Medical Group
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • San Francisco, California, United States, 94115
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • 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.
      • Kissimmee, Florida, United States, 34741
        • Digestive and Liver Disease Institute
      • Kissimmee, Florida, United States, 34741
        • Osceola Regional Hospital
      • Lakewood Rch, Florida, United States, 34211
        • Florida Research Center Inc.
      • Miami, Florida, United States, 33136
        • University of Miami
      • 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
      • Macon, Georgia, United States, 31201
        • Gastroenterolgy Associates of Central GA
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
      • Marietta, Georgia, United States, 30060
        • Atlanta Gastroenterology Associates 1
      • Roswell, Georgia, United States, 30076
        • Gastroenterology Consultants
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Gastroenterology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health University Hospital
      • New Albany, Indiana, United States, 47150
        • Gastroenterology of Southern Indiana
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Tri-State Gastroenterology Assoc
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
    • Maryland
      • Chevy Chase, Maryland, United States, 20815-7313
        • Chevy Chase Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-5400
        • Beth Israel Deaconess Medical Center
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham and Women's Hospital
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates Center for Digestive Care
    • 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
      • 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
        • University North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28277
        • Onsite Clinical Solutions
      • Charlotte, North Carolina, United States, 28210
        • Tryon Medical Group
      • Kinston, North Carolina, United States, 28501
        • Care Access Research, Kinston
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • 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
        • Gastro One
      • Johnson City, Tennessee, United States, 37604
        • Etsu Quillen College Of Medicine
      • Nashville, Tennessee, United States, 37067
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390-9063
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77346
        • GI Specialists of Houston
      • 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
        • Tyler Research Institute, LLC
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Medical College Of Virginia Hospital
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology, PLLC
      • Seattle, Washington, United States, 98111
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
      • Tacoma, Washington, United States, 98405
        • Digestive Health Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Medical College of Wisconsin

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

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
  • Moderately to severely active UC as assessed by the modified Mayo score
  • Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
  • If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

  • Has severe extensive colitis as defined in the protocol
  • Extent of inflammatory disease limited to the rectum
  • Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
  • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
  • Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

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

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 based on the modified Mayo subscores.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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 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 Improvement at Week 48
Time Frame: Week 48
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.
Week 48
Percentage of Participants with Symptomatic Remission at Week 48
Time Frame: Week 48
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.
Week 48
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Time Frame: Week 48
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.
Week 48
Serum Concentrations of Golimumab Over Time
Time Frame: Up to Week 48
Serum concentration 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 Golimumab
Time Frame: Up to Week 48
Percentage of Participants with 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 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 based on the modified Mayo subscores will be reported.
Week 48
Laboratory Parameters Over Time
Time Frame: Up to Week 48
Laboratory parameters over time will be reported.
Up to Week 48
Vital Signs Parameters Over Time
Time Frame: Up to Week 48
Vital signs 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 was 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)

September 19, 2022

Primary Completion (Actual)

May 15, 2025

Study Completion (Estimated)

March 27, 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 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109179
  • 78934804UCO2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2021-005528-39 (EudraCT Number)
  • 2023-504743-13-00 (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

No

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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