AzTrials
AzTrials

Colitis, UlcerativePhase 2DUET-UCNCT05242484

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2 study testing Guselkumab, Golimumab and JNJ-78934804 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 403 sites in 37 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Guselkumab, Golimumab and JNJ-78934804
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
577 participants
Where
403 sitesin 37 countries
Study dates
19 Sep 2022to 27 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

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

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

403 sites in 37 countries.

403 sites in 37 countries

United States63 sites

  • Valley Gastroenterology Medical Group

    Arcadia, California, 91006

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • University of Colorado

    Aurora, Colorado, 80045

  • Washington Gastroenterology, PLLC

    Bellevue, Washington, 98004

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215-5400

  • University North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Tryon Medical Group

    Charlotte, North Carolina, 28210

  • Onsite Clinical Solutions

    Charlotte, North Carolina, 28277

  • Brigham And Women's Hospital

    Chestnut Hill, Massachusetts, 02467

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815-7313

  • Pioneer Research Solutions Inc.

    Coconut Creek, Florida, 33066

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Southern California Research Center

    Coronado, California, 92118

  • Tri-State Gastroenterology Assoc

    Crestview Hills, Kentucky, 41017

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9063

  • Gastro One

    Germantown, Tennessee, 38138

  • Medical Research Center of Connecticut

    Hamden, Connecticut, 06518

  • GI Specialists of Houston

    Houston, Texas, 77346

  • Grand Teton Gastroenterology

    Idaho Falls, Idaho, 83404

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

  • Etsu Quillen College Of Medicine

    Johnson City, Tennessee, 37604

  • Care Access Research, Kinston

    Kinston, North Carolina, 28501

  • Digestive and Liver Disease Institute

    Kissimmee, Florida, 34741

  • Osceola Regional Hospital

    Kissimmee, Florida, 34741

  • Florida Research Center Inc.

    Lakewood Rch, Florida, 34211

  • Om Research LLC

    Lancaster, California, 93534

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Care Access Las Vegas

    Las Vegas, Nevada, 89148

  • Dartmouth Hitchcock

    Lebanon, New Hampshire, 03756

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Gastroenterolgy Associates of Central GA

    Macon, Georgia, 31201

  • Atlanta Gastroenterology Associates 1

    Marietta, Georgia, 30060

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • University of Miami

    Miami, Florida, 33136

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226-3522

  • Gastroenterology Group Of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37067

  • Gastroenterology of Southern Indiana

    New Albany, Indiana, 47150

  • Yale University

    New Haven, Connecticut, 06510

  • Weill Cornell Medical College

    New York, New York, 10021

  • Lenox Hill Hospital

    New York, New York, 10075

  • Omega Research Consultants

    Orlando, Florida, 32808

  • Medical College Of Virginia Hospital

    Richmond, Virginia, 23249

  • Digestive Disease Associates

    Rock Hill, South Carolina, 29732

  • Gastroenterology Consultants

    Roswell, Georgia, 30076

  • Gastroenterology Clinic Of San Antonio P A

    San Antonio, Texas, 78229

  • University of California San Francisco

    San Francisco, California, 94115

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Washington University

    St Louis, Missouri, 63110

  • Synergy Clinical Research

    St. Petersburg, Florida, 33705

  • Digestive Health Specialists

    Tacoma, Washington, 98405

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Frontier Clinical Research

    Uniontown, Pennsylvania, 15401

  • Mohawk Valley Endoscopy Center

    Utica, New York, 13502-6313

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Huron Gastroenterology Associates Center for Digestive Care

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan52 sites

  • Asahikawa Medical University Hospital

    Asahikawa, 078-8510

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113 8519

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Kitakyushu Municipal Medical Center

    Fukuoka-ken, 802-0077

  • Gifu Prefectural General Medical Center

    Gifu, 500-8717

  • Tokai University Hachioji Hospital

    Hachiōji, 192-0032

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

  • National Hospital Organization Hirosaki General Medical Center

    Hirosaki, 036-8545

  • Hirosaki University Hospital

    Hirosaki, 036-8563

  • Tokai University Hospital

    Isehara, 259-1193

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

  • Ofuna Chuo Hospital

    Kamakura, 247-0056

  • Matsushima Clinic

    Kanagawa, 220-0045

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

  • Kobe University Hospital

    Kobe, 650-0017

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-0027

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kurume University Hospital

    Kurume, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Kyoto University Hospital

    Kyoto, 606 8507

  • Gunma University Hospital

    Maebashi, 371-8511

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Iwate Medical University Hospital

    Morioka, 112-0015

  • Nagoya University Hospital

    Nagoya, 466 8560

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, 663-8501

  • Ogaki Municipal Hospital

    Ōgaki, 503-8502

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Osaka City University Hospital

    Osaka, 545-8586

  • Japan Community Health Care Organization Osaka Hospital

    Osaka, 553-0003

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041

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

    Sapporo, 060-0033

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Sapporo IBD Clinic

    Sapporo Chuo-ku, 064-0919

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575

  • The Jikei University Hospital

    Tokyo, 105 8471

  • Tokyo Saiseikai Central Hospital

    Tokyo, 108-0073

  • National Hospital Organization Tokyo Medical Center

    Tokyo, 152 8902

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Oji General Hospital

    Tomakomai, 053-8506

  • Toyama Prefectural Central Hospital

    Toyama, 930 8550

  • Toyota Kosei Hospital

    Toyota, 470-0396

  • Mie University Hospital

    Tsu, 514-8507

  • University of Tsukuba Hospital

    Tsukuba, 305 8576

  • Wakayama Medical University Hospital

    Wakayama, 641 8510

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Germany32 sites

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • Praxis Fur Gastroenteroligie

    Berlin, 10825

  • Charite - Universitaetsmedizin Berlin (CCM)

    Berlin, 12203

  • Krankenhaus Waldfriede Mitte

    Berlin, 14163

  • University Hospital Dresden

    Dresden, 1307

  • Universitaetsklinik Erlangen

    Erlangen, 91054

  • JWG-University Hospital

    Frankfurt, 69590

  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Klinikum Fulda - Tumorklinik - Germany

    Fulda, 36043

  • Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk

    Halle, 06097

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

    Heidelberg, 69115

  • University Hospital Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Jena

    Jena, 07747

  • Praxisgemeinschaft Jerichow

    Jerichow, 39319

  • Gastroenterologische Spezialpraxis - Berlin-Karlshorst

    Karlshorst, 10318

  • Eugastro GmbH

    Leipzig, 04103

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Klinikum der Universitaet Muenchen

    Munich, 81377

  • Praxis fur Innere Medizin und Gastroenterologie

    Münster, 48149

  • MVZ Portal 10

    Münster, 48155

  • Medius Klinik Nurtingen

    Nürtingen, 72622

  • Siloah St Trudpert Klinikum

    Pforzheim, 75179

  • Zentrum für Gastroenterologie Saar MVZ GmbH

    Saarbrücken, 66111

  • Universitaetsklinik Tuebingen

    Tübingen, 72076

  • Universitatsklinikum Ulm

    Ulm, 89070

  • Gemeinschaftspraxis Jakobeit

    Wipperfürth, 51688

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Poland26 sites

  • Szpital Uniwersytecki No2

    Bydgoszcz, 85-168

  • Centrum Medyczne Plejady

    Krakow, 30 363

  • Centrum Medyczne Promed

    Krakow, 31-513

  • AmiCare Centrum Medyczne

    Lodz, 90-644

  • ETG Lublin

    Lublin, 20-412

  • Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

    Lublin, 20-582

  • Allmedica

    Nowy Targ, 34 400

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10 561

  • Synexus Polska Sp z o o

    Poznan, 61 441

  • Twoja Przychodnia

    Poznan, 61-293

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • Endoskopia Sp z o.o.

    Sopot, 81-756

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • GASTROMED Sp. z o.o.

    Torun, 87 100

  • Centrum Zdrowia Matki Dziecka i Mlodziezy

    Warsaw, 00 632

  • Centralny Szpital Kliniczny Mswia

    Warsaw, 02 507

  • Reumatika-Centrum Reumatologii, NZOZ

    Warsaw, 02-655

  • NZOZ Vivamed

    Warsaw, 03 580

  • Bodyclinic Sp. z o.o. sp. k

    Warsaw, 03 712

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

    Włocławek, 87-800

  • Melita Medical Sp. z o.o.

    Wroclaw, 50 449

  • Centrum Medyczne Oporow

    Wroclaw, 52 415

  • Przychodnia Vistamed

    Wroclaw, 53 149

  • EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, 54 144

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Canada19 sites

  • Viable Clinical Research

    Bridgewater, B4V 3N2

  • Foothills Hospital

    Calgary, Alberta, T2N 2T9

  • Viable Clinical Research 1

    Dartmouth, Nova Scotia, B2W 6L4

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

  • Covenant Health/Grey Nuns hospital

    Edmonton, Alberta, T6L 6K3

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • London Health Sciences Centre - University Campus

    London, Ontario, N6A 5A5

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • McGill University - Health Centre - Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • CMIIM, Centre médical L'Enjeu

    Mount Royal, Quebec, H3P 3E5

  • Columbia Gastroenterology

    New Westminster, British Columbia

  • Hopital Chicoutimi

    Saguenay, G7H3C3

  • St. Jerome Medical Research

    Saint-Jérôme, Quebec, V8R 4R2

  • Toronto Immune and Digestive Health Institute Inc

    Toronto, Ontario, M6A 3B4

  • The Gordon & Leslie Diamond Health Care Center

    Vancouver, British Columbia, V5Z 1M9

  • GIRI Gastrointestinal Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • The Medical Arts Health Research Group

    Vancouver, British Columbia, V7M 2H4

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, V8P 2P5

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Brazil16 sites

  • Universidade Estadual Paulista 'Julio De Mesquita Filho'

    Botucatu, 18618-970

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200-730

  • Chronos Clinica Medica LTDA Chronos Pesquisa Clinica

    Brasília, 72145-450

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070-560

  • Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica

    Curitiba, 80430-180

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, 90035-001

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035-003

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina

    Rio de Janeiro, 21941-913

  • SER - Servicos Especializados em Reumatologia da Bahia

    Salvador, 40150 150

  • Pesquisare Saude

    Santo André, 09080-110

  • Irmandade da Santa Casa da Misericórdia de Santos

    Santos, 11075-101

  • Hospital Nove de Julho

    São Paulo, 01409 902

  • BR Trials

    São Paulo, 03325-050

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 04502-001

Other trials in Brazil

France16 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • Hopital Louis Mourier

    Colombes, 92701

  • Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

    Créteil, 94010

  • CHU Grenoble

    Grenoble, 38700

  • Centre Hospitalier Départemental VENDEE

    La Roche-sur-Yon, 85925

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037

  • Hopital Nord Marseille

    Marseille, 13915

  • Hopital Saint Eloi

    Montpellier, 34295

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200

  • CHU de Nice Hopital de l Archet

    Nice, 06202

  • CHU Nimes Hopital Caremeau

    Nîmes, 30029

  • Hopital Haut-Leveque, CMC Magellan

    Pessac, 33604

  • Hospices Civils de Lyon HCL

    Pierre-Bénite, 69495

  • CHU Saint Etienne

    Saint-Etienne, 42270

  • Hopital de Rangueil

    Toulouse, 31059

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

South Korea15 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Kosin University Gospel Hospital

    Busan, 49267

  • Yeungnam University Hospital

    Daegu, 42415

  • Chosun university hospital

    Gwangju, 61453

  • The Catholic university of Korea, St. Vincent's Hospital

    Gyeonggi-do, 16247

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, 18450

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • The Catholic University of Korea Seoul St.Mary's Hospital

    Seoul, 06591

  • Kyung Hee University Hospital

    Seoul, 130 050

  • The Catholic University of Korea Seoul St.Marys Hospital 1

    Seoul, 6591

  • Ajou University Hospital

    Suwon, 16499

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Italy12 sites

  • Università degli Studi di Bari

    Bari, 70124

  • A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

    Catania, 95126

  • AOU Policlinico G.Martino

    Messina, 98125

  • Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

    Monserrato, 09042

  • Azienda Ospedaliera San Gerardo

    Monza, 20090

  • Ospedale Sacro Cuore Don Calabria

    Negrar, 37024

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Università Campus Biomedico di Roma

    Roma, 00128

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

    Rozzano, 20089

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

Other trials in Italy

Australia11 sites

  • Box Hill Hospital

    Box Hill, 3128

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Monash Health, Monash Medical Centre

    Clayton, 3168

  • Concord Hospital

    Concord, 2139

  • Western Health

    Footscray, 3011

  • Coastal Digestive Health

    Maroochydore, 4558

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Royal Adelaide Hospital

    North Terrace, 5000

  • Royal Melbourne Hospital

    Parkville, 3050

  • The Alfred Hospital

    Prahran, 3004

  • Mater Hospital Brisbane

    South Brisbane, 4101

Other trials in Australia

Israel10 sites

  • Haemek Medical Center - Afula

    Afula, 1834111

  • Rambam Medical Center

    Haifa, 31096

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Hebrew University Medical Center

    Jerusalem, 91120

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

  • Assaf Harofeh Medical Center

    Tzrifin, 70300

Other trials in Israel

Belgium9 sites

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, 8000

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHC MontLegia

    Liège, 4000

  • CHU de Liege

    Liège, 4000

  • Vitaz

    Sint-Niklaas

Other trials in Belgium

India9 sites

  • M S Ramaiah Medical College and Hospital

    Bangalore, 560054

  • Siksha O Anusandhan University - Institute of Medical Scienc

    Bhubaneswar, 751003

  • Apex Hospitals Ltd

    Jaipur, 302017

  • G.B. Pant Hospital

    New Delhi, 110 002

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Fortis Hospital

    New Delhi, 110088

  • Yashoda Super Speciality Hospitals

    Secunderabad, 500003

  • Surat Institute of Digestive Sciences Hospitals

    Surat, 395002

Other trials in India

Spain8 sites

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. de Navarra

    Pamplona, 31008

  • Hosp. Montecelo

    Pontevedra, 36071

  • Corporacio Sanitari Parc Tauli

    Sabadell, 8208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Univ. de Torrejon

    Torrejón de Ardoz, 28850

  • Hosp. Alvaro Cunqueiro

    Vigo, 36213

Other trials in Spain

Hungary7 sites

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis Egyetem

    Budapest, H-1088

  • Pannónia Magánorvosi Centrum Kft

    Budapest, H-1136

  • Bugat Pal Korhaz

    Gyöngyös, 3200

  • Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp

    Szeged, 6720

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, H-9700

Other trials in Hungary

United Kingdom7 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Velocity Clinical Research

    High Wycombe, HP112QW

  • Chelsea And Westminster Hospital

    London, SW109NH

  • St Georges University Hospital NHS Foundation Trust

    London, SW17 0QT

  • John Radcliffe Hospital

    Oxford, OX3 9DU

Other trials in United Kingdom

Argentina6 sites

  • CIPREC

    Buenos Aires, C1119ACN

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo

    Ciudad Autonoma Buenos Aires, C1264AAN

  • Sanatorio Duarte Quiroz

    Córdoba, X5002AOQ

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK

  • Hospital Provincial del Centenario

    Rosario, 2002

Other trials in Argentina

Bulgaria6 sites

  • Medical Centre Hipocrat

    Haskovo, 6300

  • Diagnostic Consulting Center I Sliven

    Sliven, 8800

  • UMHAT 'Tsaritsa Yoanna'

    Sofia, 1527

  • University Hospital Alexandrovska - Clinic of Nephrology

    Sofia-Grad, 1431

  • Medical Center -Medika Plus

    Veliko Tarnovo, 5000

  • Multriprofile Hospital for Active Treatment Hristo Botev

    Vratsa, 3000

Other trials in Bulgaria

China6 sites

  • China Japan Friendship Hospital

    Chaoyang, 100013

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Jinhua municipal central hospital

    Jinhua, 321000

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022

Other trials in China

Norway6 sites

  • Alesund sjukehus

    Ålesund, 6010

  • Vestre Viken HF Baerum Sykehus

    Gjettum, 1346

  • Sykehuset Innlandet HF Gjøvik

    Gjøvik, 2819

  • Akershus Universitetssykehus

    Lørenskog, 1478

  • Oslo University Hospital HF Ulleval sykehus

    Oslo, 0450

  • Universitetssykehuset Nord-Norge HF

    Tromsø, N-9038

Other trials in Norway

Taiwan6 sites

  • Changhua Christian Hospital

    Changhua, 500

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 407204

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital, Division of Infectious Diseases

    Taipei, 100

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 33305

Other trials in Taiwan

Denmark5 sites

  • Aalborg Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus

  • Bispebjerg Og Frederiksberg Hospital

    Copenhagen, 2400

  • Herlev Hospital, University of Copenhagen

    Herlev, 2730

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Netherlands5 sites

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, 105 AZ

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • Maastricht University Medical Centre

    Maastricht, 6229 HX

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Portugal5 sites

  • Centro Hospitalar de Lisboa Norte Hospital Santa Maria

    Lisbon, 1649-035

  • Uls Loures Odivelas - Hosp. Loures

    Loures, 2674 514

  • Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

    Portimão, 8500-338

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E

    Santa Maria da Feira, 4520-211

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502

Other trials in Portugal

South Africa5 sites

  • Worthwhile Clinical Trials Lakeview Hospital

    Benoni, 1501

  • Mediclinic Panorama

    Cape Town, 7500

  • Groote Schur Hospital

    Cape Town, 7925

  • Practice Dr Naeem Moosa

    Johannesburg, 1827

  • Emmed Research

    Pretoria, 0002

Other trials in South Africa

Switzerland5 sites

  • Universitatsspital Basel

    Basel, 4031

  • Inselspital Universitatsspital Bern

    Bern, 3010

  • Gastroenterologische Praxis Balsiger und Seibold

    Bern, 3012

  • Kantonsspital St Gallen

    Sankt Gallen, 9007

  • UniversitaetsSpital Zuerich

    Zurich, 8091

Other trials in Switzerland

Austria4 sites

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Brüder

    Vienna, 1020

  • Medizinische Universitaet Wien

    Vienna, 1090

  • Klinikum Wels Grieskirchen

    Wels, 4600

Other trials in Austria

Chile4 sites

  • Hospital Clinico Regional Dr. Guillermo Grant Benavente

    Concepción, 4030000

  • Clinica Dermacross S A

    Santiago, 7640881

  • Complejo Asistencial Hospital Dr. Sótero del Río

    Santiago, 8207257

  • Centro de Estudios Clínicos e Investigación Médica (CeCim)

    Santiago, 8331143

Other trials in Chile

Greece4 sites

  • Sotiria General State Hospital of Chest Diseases

    Athens, 115 27

  • Alexandra General Hospital of Athens

    Athens, 11528

  • Nikaia General Hospital

    Piraeus, 184 54

  • Hippokration Hospital

    Thessaloniki, 54642

Other trials in Greece

Jordan4 sites

  • Istishari Hospital

    Amman, 11184

  • Jordan University Hospital

    Amman, 11942

  • Irbid Specialty Hospital

    Irbid, 21110

  • King Abdullah University Hospital

    Irbid, 22110

Other trials in Jordan

New Zealand4 sites

  • Christchurch Hospital

    Christchurch, 8140

  • Dunedin Hospital

    Dunedin, 9016

  • Hutt Hospital

    Lower Hutt, 5010

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

Slovakia4 sites

  • FNsP F.D.R. Banska Bystrica

    Banská Bystrica, 974 01

  • Cliniq s.r.o.

    Bratislava, 811 09

  • GASTRO I. s.r.o.

    Prešov, 080 01

  • Gastroenterology Department ENDOMED, s.r.o.

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Croatia3 sites

  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • University Hospital Center Split

    Split, 21000

  • University Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Estonia3 sites

  • East Tallinn Central Hospital

    Tallinn, 10138

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Czechia2 sites

  • Vojenska nemocnice Brno

    Brno, 636 00

  • ISCARE a.s.

    Prague, 170 04

Other trials in Czechia

Slovenia2 sites

  • Splosna bolnisnica Celje

    Celje, 3000

  • Univerzitetni klinicni center Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

Sweden2 sites

  • Karolinska Universitetssjukhuset Solna

    Solna, 171 76

  • Ersta sjukhus

    Stockholm, 116 91

Other trials in Sweden

About this study

Official title: 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.

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

What participants receive

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

  • GuselkumabBiological

    Guselkumab will be administered as subcutaneous injection.

  • GolimumabBiological

    Golimumab will be administered as subcutaneous injection.

  • JNJ-78934804Biological

    JNJ-78934804 will be administered subcutaneously as per defined regimen.

  • PlaceboDrug

    Placebo will be administered as subcutaneous injection.

Study groups in NCT05242484
Study groupRoleWhat they receive
Group 1: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo
Group 2: GuselkumabExperimentalParticipants 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.
Receives: Biological: Guselkumab
Group 3: GolimumabExperimentalParticipants 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.
Receives: Biological: Golimumab
Group 4: JNJ-78934804 (High-dose)ExperimentalParticipants 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.
Receives: Biological: JNJ-78934804
Group 5: JNJ-78934804 (Mid-dose)ExperimentalParticipants 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.
Receives: Biological: JNJ-78934804
Group 6: JNJ-78934804 (Low-dose)ExperimentalParticipants 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.
Receives: Biological: JNJ-78934804

What is being measured

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

  1. Percentage of Participants with Clinical Remission at Week 48

    Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.

    Measured: Week 48

Secondary outcomes (18)

  1. Percentage of Participants with Endoscopic Improvement at 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.

    Measured: Week 48

  2. Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48

    Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.

    Measured: Week 48

  3. Percentage of Participants with Symptomatic Remission at 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.

    Measured: Week 48

  4. Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at 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.

    Measured: Week 48

  5. Secondary Comparison: Percentage of Participants with Clinical Remission at 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.

    Measured: Week 48

  6. Percentage of Participants with Adverse Events (AEs)

    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.

    Measured: Up to Week 48

  7. Percentage of Participants with Serious Adverse Events (SAEs)

    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.

    Measured: Up to Week 48

  8. Laboratory Parameters Over Time

    Laboratory parameters over time will be reported.

    Measured: Up to Week 48

  9. Vital Signs Parameters Over Time

    Vital signs parameters over time will be reported.

    Measured: Up to Week 48

  10. Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score

    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.

    Measured: Up to Week 48

  11. Serum Concentrations of Guselkumab Over Time

    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.

    Measured: Up to Week 48

  12. Serum Concentrations of Golimumab Over Time

    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.

    Measured: Up to Week 48

  13. Percentage of Participants with Antibodies to Guselkumab

    Percentage of participants with antibodies to guselkumab will be reported.

    Measured: Up to Week 48

  14. Titers of Antibodies to Guselkumab

    Titers of antibodies to guselkumab will be reported.

    Measured: Up to Week 48

  15. Percentage of Participants with Antibodies to Golimumab

    Percentage of Participants with Antibodies to golimumab will be reported.

    Measured: Up to Week 48

  16. Titers of Antibodies to Golimumab

    Titers of antibodies to golimumab will be reported.

    Measured: Up to Week 48

  17. Percentage of Participants with Neutralizing Antibodies to Guselkumab

    Percentage of participants with neutralizing antibodies to guselkumab will be reported.

    Measured: Up to Week 48

  18. Percentage of Participants with Neutralizing Antibodies to Golimumab

    Percentage of participants with neutralizing antibodies to golimumab will be reported.

    Measured: Up to Week 48

Timeline

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

  1. First posted16 Feb 2022
  2. Study start19 Sep 2022
  3. Primary completion15 May 2025
  4. Study completion27 Mar 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
577 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242484
Sponsor's protocol ID
CR109179
Other IDs
78934804UCO2001, 2021-005528-39, 2023-504743-13-00, 2023
Acronym
DUET-UC
Status last verified
Nov 2026
First submitted
15 Feb 2022
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Guselkumab, Golimumab and JNJ-78934804 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 403 sites in 37 countries.

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

Who may be eligible to take part?

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

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 403 sites in United States, Japan, Germany, Poland, Canada and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05242484.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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