A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR)

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Guselkumab; Drug: Placebo

Detailed Description

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

• Study Type: Interventional
• Enrollment (Actual): 1064
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1878
    • Cer Instituto Medico
  • Buenos Aires, Argentina, 1431
    • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
  • Buenos Aires, Argentina, C1221ADC
    • Hospital General de Agudos José Maria Ramos Mejía
  • Buenos Aires, Argentina, C1056ABI
    • CINME Centro de Investigaciones Metabolicas
  • Caba, Argentina, C1426ABP
    • Centro Médico Dra. De Salvo
  • Ciudad de Buenos Aires, Argentina, C1430EGF
    • Clinica Adventista Belgrano
  • Córdoba, Argentina, X5002AOQ
    • Sanatorio Duarte Quiroz
  • Mar del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Medicas Mar Del Plata
  • Rosario, Argentina, 2000
    • Fundacion de Estudios Clinicos
  • Rosario, Argentina, S2000KDS
    • Hospital Provincial del Centenario
  • San Juan Bautista, Argentina, 1888
    • Hospital de Alta Complejidad en Red 'El Cruce'
• Australia
  • Camberwell, Australia, 3124
    • Emeritus Research
  • Clayton, Australia, 3168
    • Monash Health
  • Footscray, Australia, 3011
    • Western Health
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • Perth, Australia, 6000
    • Royal Perth Hospital
  • South Brisbane, Australia, 4101
    • Mater Hospital
  • Subiaco, Australia, 6008
    • St John of God Subiaco Hospital
  • Woolloongabba, Australia, 4102
    • Princess Alexandra Hospital
• Austria
  • Salzburg, Austria, 5020
    • Universitaetsklinikum Salzburg Landeskrankenhaus
• Belgium
  • Bruges, Belgium, 8310
    • AZ Sint Lucas 1
  • Brussels, Belgium, 1070
    • Hopital Erasme
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Merksem, Belgium, 2170
    • Algemeen Ziekenhuis Jan Palfijn Merksem
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
• Brazil
  • Brasília, Brazil, 70200 730
    • L2IP Instituto de Pesquisas Clinicas
  • Campinas, Brazil, 13060-904
    • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
  • Curitiba, Brazil, 80430-180
    • CDC - Centro Digestivo de Curitiba
  • Juiz de Fora, Brazil, 36033 318
    • Galileo Pesquisa Clinica
  • Passo Fundo, Brazil, 99010-120
    • Instituto Mederi de Pesquisa e Saude
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 90430-001
    • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
  • Rio de Janeiro, Brazil, 21941-913
    • Universidade Federal do Rio de Janeiro - Faculdade de Medicina
  • Salvador, Brazil, 41500-300
    • CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
  • São Paulo, Brazil, 01228-900
    • CPQuali Pesquisa Clinica LTDA ME
  • São Paulo, Brazil, 01401 002
    • Instituto D Or de Pesquisa e Ensino IDOR
  • São Paulo, Brazil, 01236030
    • BR Trials
  • Teresina, Brazil, 64049-550
    • Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
  • Uberlândia, Brazil, 38400-368
    • Eurolatino Pesquisas Medicas Ltda
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Medical Centre Asklepii OOD
  • Sevlievo, Bulgaria, 5400
    • Medical Center-1-Sevlievo EOOD
  • Sofia, Bulgaria, 1202
    • 2-nd MHAT
  • Sofia, Bulgaria, 1606
    • 4th MHAT - Sofia
  • Sofia, Bulgaria, 1680
    • DCC Convex EOOD
  • Sofia, Bulgaria, 1784
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
  • Varna, Bulgaria, 9010
    • MHAT 'St. Marina' EAD
  • Veliko Tarnovo, Bulgaria, 5000
    • MHAT Dr Stefan Cherkezov
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • G I R I GI Research Institute Foundation
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Barrie GI Associates
    • Toronto, Ontario, Canada, M6A 3B4
      • Toronto Immune and Digestive Health Institute Inc
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve Rosemont
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Capital Medical University, Beijing Friendship Hospital
  • Changchun, China, 130033
    • China-Japan Union Hospital of Jilin University
  • Changsha, China, 200120
    • The second Xiangya hospital of central south university
  • Changsha, China, 40013
    • The Third Xiangya Hospital of Central Sourth University
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Chongqing, China, 400042
    • Daping Hospital
  • Dalian, China, 116027
    • The Second Hospital To Dalian Medical University
  • Ganzhou, China, 341000
    • First Affiliated Hospital of Gannan Medical University
  • Guangzhou, China, 510610
    • The Sixth Affiliated Hospital Sun Yat sen University
  • Guangzhou, China, 510080
    • The First Affiliated Hospital Sun Yat sen University
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital of Zhejiang University
  • Hangzhou, China, 310003
    • The First Affiliated Hospital Zhejiang University College of Medicine
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Hefei, China, 230022
    • The First Affiliated Hospital of Anhui Medical University
  • Kunming, China, 650032
    • First Affiliated Hospital of Kunming Medical Unversity
  • Nanchang, China, 330006
    • The First Affiliated Hospital of NanChang University
  • Nanjing, China, 210029
    • Jiangsu Province Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 210009
    • Zhongda Hospital Southeast University
  • Shanghai, China, 200025
    • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
  • Shenyang, China, 110004
    • Shengjing Hospital Of China Medical University
  • Suzhou, China, 215168
    • The Second Hospital Affiliated To Suzhou University
  • Suzhou, China
    • The first affiliated hospital of suzhou University
  • Tianjin, China, 300011
    • Tianjin Medical University General Hospital
  • Wuhan, China, 430022
    • Wuhan Union Hospital
  • Wuhan, China, 430030
    • Tongji Hospital, Tongji Medical College of HUST
  • Wuxi, China, 214023
    • Wuxi People s Hospital
• Czechia
  • Havířov, Czechia, 73601
    • Asclepiades Interna a Gastroenterologie s r o
  • Hradec Kralova, Czechia, 500 02
    • Gastroenterologie, s.r.o., Hradec Kralove
  • Olomouc, Czechia, 779 00
    • MUDr. Gregar s.r.o.
  • Ostrava, Czechia, 703 84
    • Vitkovicka nemocnice a.s.
  • Ostrava, Czechia, 722 00
    • Artroscan s r o
  • Prague, Czechia, 120 00
    • Synexus Czech s.r.o.
  • Prague, Czechia, 15000
    • AXON Clinical s.r.o.
  • Prague, Czechia, 150 30
    • Nemocnice na Homolce
  • Prague, Czechia, 190 00
    • ISCARE a.s.
  • Prague, Czechia, 143 00
    • ResTrial GastroEndo, s.r.o
  • Strakonice, Czechia, 386 29
    • Nemocnice Strakonice, a.s.
  • České Budějovice, Czechia, 37001
    • Nemocnice Ceske Budejovice a s
• France
  • Caen, France, 14033
    • CHU caen
  • Clichy, France, 92110
    • Hopital Beaujon
  • Lille, France, 59000
    • CHRU de Lille Hopital Claude Huriez
  • Montpellier, France, 34295
    • Hopital Saint Eloi
  • Nice, France, 62002
    • CHU de Nice Hopital de l Archet
  • Paris, France, 75571
    • Hopital Saint Antoine
  • Pessac, France, 33604
    • Hopital Haut-Leveque, CMC Magellan
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Saint-Priest-en-Jarez, France, 42270
    • CHU Saint Etienne Hopital Nord
  • Strasbourg, France, 67091
    • Nouvel Hopital Civil
  • Toulouse, France, 31059
    • CHU Rangueil
  • Vandœuvre-lès-Nancy, France, 54511
    • CHRU Nancy Brabois
• Germany
  • Berlin, Germany, 13353
    • Universitaetsklinikum Charite, Campus Virchow Klinikum
  • Halle, Germany, 06108
    • BSF Studiengesellschaft
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Jerichow, Germany, 39319
    • Praxisgemeinschaft Jerichow
  • Lüneburg, Germany, 21339
    • Staedtisches Klinikum Lueneburg
  • Saarbrücken, Germany, 66111
    • Zentrum für Gastroenterologie Saar MVZ GmbH
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft
  • Budapest, Hungary, 1088
    • Semmelweis University
  • Budapest, Hungary, 1082
    • Semmelweis University 1
  • Debrecen, Hungary, H-4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4025
    • Vasutegeszsegugyi Nonprofit Kozhasznu Kft
  • Gyula, Hungary, 5700
    • Synexus Magyarorszag Kft 1
  • Gyöngyös, Hungary, 3200
    • Gyongyosi Bugat Pal Korhaz
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika
• Ireland
  • Dublin, Ireland, 9
    • Beaumont Hospital
  • Dublin, Ireland, D04T6F4
    • St Vincent's University Hospital
  • Galway, Ireland, H91YR71
    • University Hospital Galway - Ireland
• Israel
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Haifa, Israel, 3449419
    • Bnai Zion Medical Center
  • Holon, Israel, 58100
    • Wolfson Medical Center
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 93624
    • Lev Talpiot Clinic
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Tel Aviv, Israel, 6423914
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bologna, Italy, 40138
    • Policlinico Sant'Orsola Malpighi
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Negrar, Italy, 37024
    • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Palermo, Italy, 90146
    • Ospedale Villa Sofia-Cervello
  • Rho, Italy
    • Azienda Ospedaliera G.Salvini Ospedale di Rho
  • Roma, Italy, 00128
    • Università Campus Biomedico di Roma
  • Roma, Italy, 00168
    • Fondazione Policlinico Gemelli Università Cattolica
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas Rozzano, IRCCS
  • San Giovanni Rotondo, Italy, 71013
    • Casa Sollievo Della Sofferenza IRCCS
  • Torino, Italy, 10128
    • AO Ordine Mauriziano
• Japan
  • Bunkyō City, Japan, 113 8519
    • Institute of Science Tokyo Hospital
  • Chiba, Japan, 279 0021
    • Juntendo University Hospital Urayasu
  • Chikushino-shi, Japan, 818-8502
    • Fukuoka University Chikushi Hospital
  • Ehime, Japan, 790-0024
    • Ehime Prefectural Central Hospital
  • Fujiidera-shi, Japan, 583-0027
    • Sai Gastroenterology Proctology
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Fukuoka-ken, Japan, 802-0077
    • Kitakyushu Municipal Medical Center
  • Fukushima, Japan, 960 1295
    • Fukushima Medical University Hospital
  • Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Hachinohe, Japan, 031-8555
    • Hachinohe City Hospital
  • Hachiōji, Japan, 192-0032
    • Tokai University Hachioji Hospital
  • Hakodate, Japan, 040 8611
    • Hakodate Goryoukaku Hospital
  • Hamamatsu, Japan, 432-8061
    • Matsuda Hospital
  • Hashima-gun, Japan, 501-6062
    • Matsunami General Hospital
  • Hirosaki, Japan, 036-8563
    • Hirosaki University Hospital
  • Hirosaki, Japan, 036-8545
    • National Hospital Organization Hirosaki General Medical Center
  • Hiroshima, Japan, 737-8505
    • Kure Kyosai Hospital
  • Hokkaido, Japan, 078 8510
    • Asahikawa Medical University Hospital
  • Ibaraki, Japan, 311-4198
    • Mito Saiseikai General Hospital
  • Izumo, Japan, 693-8501
    • Shimane University Hospital
  • Kagoshima, Japan, 892-0846
    • Sameshima Hospital
  • Kagoshima, Japan, 890-0064
    • Imamura General Hospital
  • Kagoshima, Japan, 892-0824
    • Izuro Imamura Hospital
  • Kagoshima, Japan, 892-0843
    • Kagoshima IBD Gastroenterology Clinic
  • Kagoshima, Japan, 890-8544
    • Kagoshima University Hospital
  • Kanagawa, Japan, 220-0041
    • Matsushima Hospital
  • Kanagawa, Japan, 216 8511
    • St Marianna University Hospital
  • Kanazawa, Japan, 920-8650
    • National Hospital Organization Kanazawa Medical Center
  • Kanazawa, Japan, 920 8641
    • Kanazawa University Hospital
  • Kashihara, Japan, 634-8522
    • Nara Medical University Hospital
  • Kashiwa, Japan, 277-0871
    • Tsujinaka Hospital Kashiwanoha
  • Kashiwa, Japan, 277 -8567
    • The Jikei University Kashiwa Hospital
  • Kitakyushu, Japan, 800-0296
    • Kyushu Rosai Hospital
  • Kobe, Japan, 650-0015
    • Aoyama Naika Clinic
  • Kobe, Japan, 650 0017
    • Kobe University Hospital
  • Kochi, Japan, 780-8077
    • National Hospital Organization Kochi National Hospital
  • Kofu, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
  • Kumagaya-shi, Japan, 360-8567
    • Kumagaya General Hospital
  • Kure, Japan, 736-0023
    • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Matsumoto, Japan, 399-8701
    • National Hospital Organization Matsumoto Medical Center
  • Meguro Ku, Japan, 152 8902
    • National Hospital Organization Tokyo Medical Center
  • Minatoku, Japan, 108-8642
    • Kitasato University Kitasato Institute Hospital
  • Mitaka, Japan, 181-8611
    • Kyorin University Hospital
  • Miyagi, Japan, 981-3213
    • Takagi Clinic
  • Morioka, Japan, 020-8505
    • Iwate Medical University Uchimaru Medical Center
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Nagoya, Japan, 466 8560
    • Nagoya University Hospital
  • Niigata, Japan, 940-8653
    • Nagaoka Chuo General Hospital
  • Nishinomiya Shi, Japan, 663 8501
    • Hyogo Medical University Hospital
  • Okinawa, Japan, 904-2195
    • Nakagami Hospital
  • Osaka, Japan, 543-8555
    • Japanese Red Cross Osaka Hospital
  • Osaka, Japan, 595-0027
    • Izumiotsu Municipal Hospital
  • Osaka, Japan, 545 8586
    • Osaka Metropolitan University Hospital
  • Saitama, Japan, 330-0074
    • Japan Community Health Care Organization Saitama Medical Center
  • Sakai, Japan, 590 0197
    • Kindai University Hospital
  • Sakura, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Sapporo, Japan, 065-0033
    • Sapporo Higashi Tokushukai Hospital
  • Sapporo, Japan, 060-8543
    • Sapporo Medical University Hospital
  • Sapporo, Japan, 004-0041
    • Sapporo Tokushukai Hospital
  • Sapporo, Japan, 060-0033
    • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  • Sapporo, Japan, 064-0919
    • Sapporo IBD Clinic
  • Shinjuku-ku, Japan, 169-0073
    • Tokyo Yamate Medical Center
  • Sumida Ku, Japan, 130 8575
    • Tokyo Metropolitan Bokutoh Hospital
  • Takamatsu, Japan, 760-8557
    • Kagawa Prefectural Central Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 105 8471
    • The Jikei University Hospital
  • Tsu, Japan, 514-8507
    • Mie University Hospital
  • Yokkaichi, Japan, 510-0016
    • Yokkaichi Hazu Medical Center
  • Yokohama, Japan, 221 0855
    • Yokohama Municipal Citizen's Hospital
  • Yoshida, Japan, 910-1193
    • University of Fukui Hospital
  • Ōita, Japan, 870-0033
    • Oita Red Cross Hospital
  • Ōita, Japan, 874-8538
    • Shinbeppu Hospital
  • Ōsaki, Japan, 989-6183
    • Osaki Citizen Hospital
• Jordan
  • Amman, Jordan, 11942
    • Jordan University Hospital
  • Amman, Jordan
    • Istishari Hospital
  • Amman, Jordan
    • Khalidi Hospital and Medical Center
  • Irbid, Jordan, 22110
    • King Abdullah University Hospital
  • Irbid, Jordan, 21166
    • Irbid Specialty Hospital
• Latvia
  • Riga, Latvia, LV1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV1003
    • Health Centre 4 Centre of Diagnostics
  • Riga, Latvia, LV1079
    • Digestive Diseases Centre GASTRO
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital 1
• Malaysia
  • Kajang, Malaysia, 43000
    • Hospital Serdang
  • Kelantan, Malaysia, 16150
    • Hospital University Sains Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 56000
    • Pusat Perubatan Universiti Kebangsaan Malaysia
• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
• New Zealand
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
  • Grafton, New Zealand, 1023
    • Auckland City Hospital
  • Hamilton, New Zealand, 3204
    • Waikato Hospital
• Poland
  • Bialystok, Poland, 15-322
    • Gastromed Kralisz Romatowski Stachurska Sp. j.
  • Bydgoszcz, Poland, 85 229
    • Centrum Medyczne Medis
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed
  • Krakow, Poland, 30 363
    • Centrum Medyczne Plejady
  • Lublin, Poland, 20-583
    • Gastromed ZOZ
  • Oświęcim, Poland, 32-600
    • Medicome Sp z o.o.
  • Rzeszów, Poland, 35-326
    • Centrum Medyczne MEDYK
  • Sopot, Poland, 81-756
    • Endoskopia Sp z o.o.
  • Szczecin, Poland, 71-434
    • Uromed Jakub Koteras Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Torun, Poland, 87 100
    • GASTROMED Sp. z o.o.
  • Warsaw, Poland, 02-507
    • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
  • Warsaw, Poland, 04 501
    • WIP Warsaw IBD Point Profesor Kierkus
  • Warsaw, Poland, 04 349
    • Wojskowy Instytut Medyczny
  • Wroclaw, Poland, 51-685
    • Wro Medica
  • Wroclaw, Poland, 53 611
    • Melita Medical Sp. z o.o.
  • Zamość, Poland, 22 400
    • ETG Zamosc
• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitário de Coimbra, EPE
  • Porto, Portugal, 4200 319
    • Uls Sao Joao - Hosp. Sao Joao
  • Porto, Portugal, 4099 001
    • Uls Santo Antonio - Hosp. Santo Antonio
  • Santa Maria da Feira, Portugal, 4520-211
    • Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao
  • Viseu, Portugal, 3504-509
    • Centro Hospitalar de Tondela Viseu, EPE
• Russia
  • Kaliningrad, Russia, 236016
    • Immanuel Kant Baltic Federal University
  • Nizhny Novgorod, Russia, 603140
    • Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways
  • Novosibirsk, Russia, 630005
    • Medical Center SibNovoMed LLC
  • Novosibirsk, Russia, 630007
    • LLC 'Novosibirsk Gastrocentr'
  • Perm, Russia, 614068
    • City Clinical Hospital #2
  • Rostov-on-Don, Russia, 344022
    • Rostov State Medical University
  • Rostov-on-Don, Russia, 344022
    • Rostov State Medical University 1
  • Saint Petersburg, Russia, 191186
    • International Medical Centre SOGAZ
  • Saint Petersburg, Russia, 194044
    • All-Russian Center of Emergency and Radiation Medicine MCRS
  • Saint Petersburg, Russia, 196143
    • Eco-safety Ltd
  • Samara, Russia, 443001
    • Medical University Reaviz
  • Samara, Russia, 443041
    • NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
  • Saratov, Russia, 410053
    • Saratov Regional Clinical Hospital
  • Ufa, Russia, 450005
    • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
  • Ufa, Russia, 450071
    • City Clinical Hospital # 21
  • Yaroslavl, Russia, 150062
    • Regional Clinical Hospital 1
  • Yekaterinburg, Russia, 620075
    • Medical Center Meditsinskie Tekhnologii
  • Yekaterinburg, Russia, 620109
    • OOO MO New Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Zvezdara University Medical Center
  • Sombor, Serbia, 25101
    • General Hospital 'Dr Radivoj Simonovic'
  • Zrenjanin, Serbia, 23000
    • General Hospital 'Djordje Joanovic'
• Slovakia
  • Banská Bystrica, Slovakia, 975 17
    • FNsP F.D.R. Banska Bystrica
  • Bardejov, Slovakia, 085 01
    • Gastroenterology Department GASTROMART s.r.o.
  • Bratislava, Slovakia, 811 08
    • Gastroenterology Center ASSIDUO
  • Bratislava, Slovakia, 811 09
    • Cliniq s.r.o.
  • Košice, Slovakia, 040 13
    • ENDOMED s.r.o
  • Prešov, Slovakia, 080 01
    • GASTRO I. s.r.o.
  • Šahy, Slovakia, 93601
    • Accout Center, s.r.o., Gastroenterologická ambulancia
• South Korea
  • Busan, South Korea, 612-896
    • Inje University Haeundae Paik Hospital
  • Daegu, South Korea, 42415
    • Yeungnam University Hospital
  • Gyeonggi-do, South Korea, 16247
    • The Catholic university of Korea, St. Vincent's Hospital
  • Gyeonggi-do, South Korea, 15355
    • Korea University Ansan Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • 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, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Seoul, South Korea, 06973
    • Chung-Ang University Hospital
  • Seoul, South Korea, 02447
    • KyungHee University Hospital
  • Suwon, South Korea, 16499
    • Ajou University Hospital
• Spain
  • Badalona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Girona, Spain, 17007
    • Hosp. Univ. Dr. Josep Trueta
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Seville, Spain, 41014
    • Hosp. Ntra. Sra. de Valme
• Sweden
  • Stockholm, Sweden, SE-171 76
    • Karolinska Universitetssjukhuset
  • Uppsala, Sweden, SE 75185
    • Uppsala University
• Taiwan
  • Changhua, Taiwan, 50006
    • Chang-Hua Christian Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 33305
    • Chang-Gung Memorial Hospital, LinKou Branch
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Hospital
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul University Istanbul Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34734
    • Acibadem Kozyatagi Hospital
  • Istanbul, Turkey (Türkiye), 34520
    • Medicana International Istanbul
  • Istanbul, Turkey (Türkiye), 34732
    • BAU Medical Park Goztepe Hospital
  • Izmir, Turkey (Türkiye), 35100
    • Ege University Medical Faculty
  • Izmir, Turkey (Türkiye), 35330
    • Dokuz Eylul University Medical Faculty
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli University Medical Faculty
  • Mersin, Turkey (Türkiye), 33110
    • Mersin University Medical Faculty Hospital
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76008
    • Municipal Non-Profit Enterprise Ivano Frankivsk Regional Clinical Hospital
  • Kharkiv, Ukraine, 61037
    • Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
  • Kharkiv, Ukraine, 61039
    • SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
  • Kherson, Ukraine, 73003
    • Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
  • Kyiv, Ukraine, 02091
    • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
  • Kyiv, Ukraine, 04116
    • MC PE Sygma
  • Lviv, Ukraine, 79019
    • Limited Liability Company Progastro Clinic
  • Lviv, Ukraine, 79034
    • Kalyna Center of Modern Medicine
  • Odesa, Ukraine, 65025
    • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
  • Sumy, Ukraine, 40022
    • Sumy Regional Clinical Hospital a Non-profit Enterprise of Sumy Regional Council
  • Ternopil, Ukraine, 46002
    • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
  • Vinnytsia, Ukraine, 21009
    • Health Clinic Limited Liability Company
  • Vinnytsia, Ukraine, 21018
    • Municipal Non-Profit Enterprise M I Pyrohov Vinnytsia Regional Clinical Hospital
• United Kingdom
  • Glasgow, United Kingdom, G4 0SF
    • Glasgow Royal Infirmary
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' Hospital
  • London, United Kingdom, SW17 0QT
    • St Georges Hospital
• United States
  • California
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Los Angeles, California, United States, 90095
      • UCLA
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates 1
  • Florida
    • Gainesville, Florida, United States, 32605
      • Florida Research Network, LLC
    • Gainesville, Florida, United States, 32608
      • University of Florida Health Jacksonville
    • Hialeah, Florida, United States, 33016
      • Harmony Medical Research Institute, Inc.
    • Jacksonville, Florida, United States, 32209
      • UF Health Jacksonville Gastroenterology Emerson
    • Kissimmee, Florida, United States, 34741
      • I.H.S. Health. LLC
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services LLC
    • Miami, Florida, United States, 33155
      • Vista Health Research, LLC
    • Orlando, Florida, United States, 32806
      • Orlando Health
    • Orlando, Florida, United States, 32825
      • Care Access Research, Orlando
    • Pinellas Park, Florida, United States, 33781
      • Synexus Clinical Research US Inc 2
    • Tampa, Florida, United States, 33606
      • Univ. of South Florida Med. Group
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30310
      • Morehouse School of Medicine
    • Atlanta, Georgia, United States, 30224
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates 1
    • Decatur, Georgia, United States, 30033
      • Atlanta Center For Gastroenterology
    • Macon, Georgia, United States, 31201
      • Gastroenterolgy Associates of Central GA
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kansas
    • Pratt, Kansas, United States, 67124
      • Health Science Research Center
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology Assoc
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Clinical Research Institute of Michigan, LLC
    • Farmington Hills, Michigan, United States, 48334
      • Revive Research Institute
    • Grand Rapids, Michigan, United States, 49525
      • Infusion Associates
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid-America Gastro-Intestinal Consultants
    • St Louis, Missouri, United States, 63108
      • Barnes-Jewish Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
    • Raleigh, North Carolina, United States, 27609
      • Duke University Hospital Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Synexus Clinical Research US Inc
    • Springboro, Ohio, United States, 45066
      • Digestive Specialists, Inc
    • Westlake, Ohio, United States, 44145
      • Gastro Intestinal Research Institute of Northern Ohio LLC
    • Youngstown, Ohio, United States, 44514
      • Care Access Research, Poland
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • Digestive Disease Specialists Inc
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • US Digestive Health
  • South Carolina
    • Anderson, South Carolina, United States, 29621-2062
      • Synexus Clinical Research US Inc 1
    • Orangeburg, South Carolina, United States, 29118
      • Gastroenterology Associates of Orangeburg, SC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Lubbock, Texas, United States, 79424
      • Caprock Gastro Research
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Utah
    • Ogden, Utah, United States, 84403
      • Care Access Research, Ogden
    • Salt Lake City, Utah, United States, 84124
      • Care Access Research- Salt Lake City
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
  • Washington
    • Seattle, Washington, United States, 98104
      • UW-Harborview Medical Center
    • Spokane, Washington, United States, 99208
      • Providence Medical Group
    • Spokane, Washington, United States, 99218
      • Velocity Clinical Research Spokane
  • Wyoming
    • Casper, Wyoming, United States, 10456
      • Care Access Research, Casper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented diagnosis of ulcerative colitis (UC)
• Moderately to severely active UC, defined by modified Mayo score
• Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
• Screening laboratory test results within the parameters specified in the protocol

Exclusion Criteria:

• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
• UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
• Presence of a stoma
• Presence or history of a fistula
• Receiving prohibited medications and/or treatment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction Study 1: Guselkumab Dose 1; Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.	Drug: Guselkumab; Participants will receive guselkumab IV or SC.
Experimental: Induction Study 1: Guselkumab Dose 2; Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.	Drug: Guselkumab; Participants will receive guselkumab IV or SC.
Placebo Comparator: Induction Study 1: Placebo IV; Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.	Drug: Placebo; Participants will receive matching placebo IV or SC.
Experimental: Induction Study 2: Guselkumab IV; Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.	Drug: Guselkumab; Participants will receive guselkumab IV or SC.
Placebo Comparator: Induction Study 2: Placebo IV; Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.	Drug: Placebo; Participants will receive matching placebo IV or SC.
Experimental: Maintenance Study: Maintenance Dose Regimen 1; Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).	Drug: Guselkumab; Participants will receive guselkumab IV or SC.
Experimental: Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).	Drug: Guselkumab; Participants will receive guselkumab IV or SC.
Placebo Comparator: Maintenance Study: Placebo SC; Participants will receive matching placebo SC q4w.	Drug: Placebo; Participants will receive matching placebo IV or SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction Study 1: Percentage of Participants With Clinical Response at Week I-12	Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.	At Week I-12
Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12	Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.	At Week I-12
Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44	Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.	At Week M-44

Secondary Outcome Measures

Outcome Measure	Time Frame
Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12	At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Clinical Response at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4	At Week I-4
Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12	At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2	At Week I-2
Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12	At Week I-12
Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Clinical Response at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44	At Week M-44
Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline	At Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44	At Week M-44

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Chen B, Ye BD, Cao Q, Hirai F, Saruta M, Chen M, Pelak S, Shipitofsky N, Miao Y, Herr K, Wahking B, Zhuo J, Hisamatsu T. Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies. J Gastroenterol Hepatol. 2025 Sep;40(9):2197-2208. doi: 10.1111/jgh.17036. Epub 2025 Jun 26.
• Rubin DT, Allegretti JR, Panes J, Shipitofsky N, Yarandi SS, Huang KG, Germinaro M, Wilson R, Zhang H, Johanns J, Feagan BG, Hisamatsu T, Lichtenstein GR, Bressler B, Peyrin-Biroulet L, Sands BE, Dignass A; QUASAR Study Group. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025 Jan 4;405(10472):33-49. doi: 10.1016/S0140-6736(24)01927-5. Epub 2024 Dec 17.
• Peyrin-Biroulet L, Allegretti JR, Rubin DT, Bressler B, Germinaro M, Huang KG, Shipitofsky N, Zhang H, Wilson R, Han C, Feagan BG, Sandborn WJ, Panes J, Hisamatsu T, Lichtenstein GR, Sands BE, Dignass A; QUASAR Study Group. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023 Sep 1.
• Hart A, Sridhar S, Venkat S, Lee T, Rusbuldt JJ, Richards D, Sisk C, Horowitz D, Tomsho L, Kannan AK, Ruane D, Van den Berge K, Rubin DT, Sands BE, De Hertogh G, Huang KG, Germinaro M, Cua D, Waterworth D, Freeman TC, Vetter ML, McRae B, Verstockt B, Branigan P. Multiomic characterisation of the clinical efficacy of guselkumab induction therapy in ulcerative colitis. BMJ Open Gastroenterol. 2026 Mar 23;13(1):e002153. doi: 10.1136/bmjgast-2025-002153.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): September 19, 2023
• Study Completion (Estimated): September 29, 2027

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Substandard Drugs; Pharmaceutical Preparations; guselkumab
• Other Study ID Numbers: CR108657; 2018-004002-25 (EudraCT Number); CNTO1959UCO3001 (Other Identifier: Janssen Research & Development, LLC); 2023-504718-31-00 (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