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
4 other identifiers
interventional
1,064
32 countries
382
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2019
Longer than P75 for phase_2
382 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2023
CompletedResults Posted
Study results publicly available
November 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2027
ExpectedJune 5, 2026
June 1, 2026
4 years
July 24, 2019
September 18, 2024
June 4, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (23)
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
- +18 more secondary outcomes
Study Arms (8)
Induction Study 1: Guselkumab Dose 1
EXPERIMENTALParticipants 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.
Induction Study 1: Guselkumab Dose 2
EXPERIMENTALParticipants 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.
Induction Study 1: Placebo IV
PLACEBO COMPARATORParticipants 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.
Induction Study 2: Guselkumab IV
EXPERIMENTALParticipants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
Induction Study 2: Placebo IV
PLACEBO COMPARATORParticipants 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.
Maintenance Study: Maintenance Dose Regimen 1
EXPERIMENTALParticipants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
Maintenance Study: Maintenance Dose Regimen 2
EXPERIMENTALParticipants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
Maintenance Study: Placebo SC
PLACEBO COMPARATORParticipants will receive matching placebo SC q4w.
Interventions
Participants will receive matching placebo IV or SC.
Participants will receive guselkumab IV or SC.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (392)
Om Research LLC
Lancaster, California, 93534, United States
UCLA
Los Angeles, California, 90095, United States
Peak Gastroenterology Associates 1
Colorado Springs, Colorado, 80907, United States
Florida Research Network, LLC
Gainesville, Florida, 32605, United States
University of Florida Health Jacksonville
Gainesville, Florida, 32608, United States
Harmony Medical Research Institute, Inc.
Hialeah, Florida, 33016, United States
UF Health Jacksonville Gastroenterology Emerson
Jacksonville, Florida, 32209, United States
I.H.S. Health. LLC
Kissimmee, Florida, 34741, United States
Columbus Clinical Services LLC
Miami, Florida, 33125, United States
Vista Health Research, LLC
Miami, Florida, 33155, United States
Orlando Health
Orlando, Florida, 32806, United States
Care Access Research, Orlando
Orlando, Florida, 32825, United States
Synexus Clinical Research US Inc 2
Pinellas Park, Florida, 33781, United States
Univ. of South Florida Med. Group
Tampa, Florida, 33606, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30224, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Atlanta Gastroenterology Associates 1
Atlanta, Georgia, 30342, United States
Atlanta Center For Gastroenterology
Decatur, Georgia, 30033, United States
Gastroenterolgy Associates of Central GA
Macon, Georgia, 31201, United States
University of Chicago
Chicago, Illinois, 60637, United States
Health Science Research Center
Pratt, Kansas, 67124, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, 48038, United States
Revive Research Institute
Farmington Hills, Michigan, 48334, United States
Infusion Associates
Grand Rapids, Michigan, 49525, United States
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri, 64111, United States
Barnes-jewish Hospital
St Louis, Missouri, 63108, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke University Hospital Medical Center
Raleigh, North Carolina, 27609, United States
Synexus Clinical Research US Inc
Columbus, Ohio, 43212, United States
Digestive Specialists, Inc
Springboro, Ohio, 45066, United States
Gastro Intestinal Research Institute of Northern Ohio LLC
Westlake, Ohio, 44145, United States
Care Access Research, Poland
Youngstown, Ohio, 44514, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73114, United States
US Digestive Health
Wyomissing, Pennsylvania, 19610, United States
Synexus Clinical Research US Inc 1
Anderson, South Carolina, 29621-2062, United States
Gastroenterology Associates of Orangeburg, SC
Orangeburg, South Carolina, 29118, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Caprock Gastro Research
Lubbock, Texas, 79424, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Care Access Research, Ogden
Ogden, Utah, 84403, United States
Care Access Research- Salt Lake City
Salt Lake City, Utah, 84124, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
UW-Harborview Medical Center
Seattle, Washington, 98104, United States
Providence Medical Group
Spokane, Washington, 99208, United States
Velocity Clinical Research Spokane
Spokane, Washington, 99218, United States
Care Access Research, Casper
Casper, Wyoming, 10456, United States
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires, 1431, Argentina
Cer Instituto Medico
Buenos Aires, 1878, Argentina
CINME Centro de Investigaciones Metabolicas
Buenos Aires, C1056ABI, Argentina
Hospital General de Agudos José Maria Ramos Mejía
Buenos Aires, C1221ADC, Argentina
Centro Médico Dra. De Salvo
Caba, C1426ABP, Argentina
Clinica Adventista Belgrano
Ciudad de Buenos Aires, C1430EGF, Argentina
Sanatorio Duarte Quiroz
Córdoba, X5002AOQ, Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK, Argentina
Fundacion de Estudios Clinicos
Rosario, 2000, Argentina
Hospital Provincial del Centenario
Rosario, S2000KDS, Argentina
Hospital de Alta Complejidad en Red 'El Cruce'
San Juan Bautista, 1888, Argentina
Emeritus Research
Camberwell, 3124, Australia
Monash Health
Clayton, 3168, Australia
Western Health
Footscray, 3011, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Royal Perth Hospital
Perth, 6000, Australia
Mater Hospital
South Brisbane, 4101, Australia
St John of God Subiaco Hospital
Subiaco, 6008, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, 5020, Austria
AZ Sint Lucas 1
Bruges, 8310, Belgium
CHU Saint-Pierre
Brussels, 1000, Belgium
Hopital Erasme
Brussels, 1070, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Algemeen Ziekenhuis Jan Palfijn Merksem
Merksem, 2170, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
L2IP Instituto de Pesquisas Clinicas
Brasília, 70200 730, Brazil
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, 13060-904, Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, 80430-180, Brazil
Galileo Pesquisa Clinica
Juiz de Fora, 36033 318, Brazil
Instituto Mederi de Pesquisa e Saude
Passo Fundo, 99010-120, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, 90430-001, Brazil
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
Rio de Janeiro, 21941-913, Brazil
CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao
Salvador, 41500-300, Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, 01228-900, Brazil
BR Trials
São Paulo, 01236030, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 01401 002, Brazil
Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
Teresina, 64049-550, Brazil
Eurolatino Pesquisas Medicas Ltda
Uberlândia, 38400-368, Brazil
Medical Centre Asklepii OOD
Dupnitsa, 2600, Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
2-nd MHAT
Sofia, 1202, Bulgaria
4th MHAT - Sofia
Sofia, 1606, Bulgaria
DCC Convex EOOD
Sofia, 1680, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, 1784, Bulgaria
MHAT 'St. Marina' EAD
Varna, 9010, Bulgaria
MHAT Dr Stefan Cherkezov
Veliko Tarnovo, 5000, Bulgaria
G I R I GI Research Institute Foundation
Vancouver, British Columbia, V6Z 2K5, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, M6A 3B4, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Capital Medical University, Beijing Friendship Hospital
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100191, China
China-Japan Union Hospital of Jilin University
Changchun, 130033, China
The second Xiangya Hospital of Central South University
Changsha, 200120, China
The Third Xiangya Hospital of Central Sourth University
Changsha, 40013, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Daping Hospital
Chongqing, 400042, China
The Second Hospital To Dalian Medical University
Dalian, 116027, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, 341000, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080, China
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, 510610, China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
First Affiliated Hospital of Kunming Medical Unversity
Kunming, 650032, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
Jiangsu Province Hospital
Nanjing, 210029, China
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
Shanghai, 200025, China
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
The Second Hospital Affiliated To Suzhou University
Suzhou, 215168, China
The first affiliated hospital of suzhou University
Suzhou, China
Tianjin Medical University General Hospital
Tianjin, 300011, China
Wuhan Union Hospital
Wuhan, 430022, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030, China
Wuxi People s Hospital
Wuxi, 214023, China
Nemocnice Ceske Budejovice a s
České Budějovice, 37001, Czechia
Asclepiades Interna a Gastroenterologie s r o
Havířov, 73601, Czechia
Gastroenterologie, s.r.o., Hradec Kralove
Hradec Kralova, 500 02, Czechia
MUDr. Gregar s.r.o.
Olomouc, 779 00, Czechia
Vitkovicka nemocnice a.s.
Ostrava, 703 84, Czechia
Artroscan s r o
Ostrava, 722 00, Czechia
Synexus Czech s.r.o.
Prague, 120 00, Czechia
ResTrial GastroEndo, s.r.o
Prague, 143 00, Czechia
Nemocnice na Homolce
Prague, 150 30, Czechia
AXON Clinical s.r.o.
Prague, 15000, Czechia
ISCARE a.s.
Prague, 190 00, Czechia
Nemocnice Strakonice, a.s.
Strakonice, 386 29, Czechia
CHU caen
Caen, 14033, France
Hopital Beaujon
Clichy, 92110, France
CHRU de Lille Hopital Claude Huriez
Lille, 59000, France
Hopital Saint Eloi
Montpellier, 34295, France
CHU de Nice Hopital de l Archet
Nice, 62002, France
Hopital Saint Antoine
Paris, 75571, France
Hopital Haut-Leveque, CMC Magellan
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Nouvel Hopital Civil
Strasbourg, 67091, France
CHU Rangueil
Toulouse, 31059, France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Universitaetsklinikum Charite, Campus Virchow Klinikum
Berlin, 13353, Germany
BSF Studiengesellschaft
Halle, 06108, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Praxisgemeinschaft Jerichow
Jerichow, 39319, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, 21339, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, 66111, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Synexus Magyarorszag Kft
Budapest, 1036, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062, Hungary
Semmelweis University 1
Budapest, 1082, Hungary
Semmelweis University
Budapest, 1088, Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
Debrecen, 4025, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, H-4032, Hungary
Gyongyosi Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
Synexus Magyarorszag Kft 1
Gyula, 5700, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika
Szeged, 6725, Hungary
Beaumont Hospital
Dublin, 9, Ireland
St Vincent's University Hospital
Dublin, D04T6F4, Ireland
University Hospital Galway - Ireland
Galway, H91YR71, Ireland
Rambam Medical Center
Haifa, 31096, Israel
Bnai Zion Medical Center
Haifa, 3449419, Israel
Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Lev Talpiot Clinic
Jerusalem, 93624, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423914, Israel
Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
Negrar, 37024, Italy
Azienda Ospedaliera di Padova
Padova, 35128, Italy
Ospedale Villa Sofia-Cervello
Palermo, 90146, Italy
Azienda Ospedaliera G.Salvini Ospedale di Rho
Rho, Italy
Università Campus Biomedico di Roma
Roma, 00128, Italy
Fondazione Policlinico Gemelli Università Cattolica
Roma, 00168, Italy
Istituto Clinico Humanitas Rozzano, IRCCS
Rozzano, 20089, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
AO Ordine Mauriziano
Torino, 10128, Italy
Institute of Science Tokyo Hospital
Bunkyō City, 113 8519, Japan
Juntendo University Hospital Urayasu
Chiba, 279 0021, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Ehime Prefectural Central Hospital
Ehime, 790-0024, Japan
Sai Gastroenterology Proctology
Fujiidera-shi, 583-0027, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kitakyushu Municipal Medical Center
Fukuoka-ken, 802-0077, Japan
Fukushima Medical University Hospital
Fukushima, 960 1295, Japan
Gifu University Hospital
Gifu, 501-1194, Japan
Hachinohe City Hospital
Hachinohe, 031-8555, Japan
Tokai University Hachioji Hospital
Hachiōji, 192-0032, Japan
Hakodate Goryoukaku Hospital
Hakodate, 040 8611, Japan
Matsuda Hospital
Hamamatsu, 432-8061, Japan
Matsunami General Hospital
Hashima-gun, 501-6062, Japan
National Hospital Organization Hirosaki General Medical Center
Hirosaki, 036-8545, Japan
Hirosaki University Hospital
Hirosaki, 036-8563, Japan
Kure Kyosai Hospital
Hiroshima, 737-8505, Japan
Asahikawa Medical University Hospital
Hokkaido, 078 8510, Japan
Mito Saiseikai General Hospital
Ibaraki, 311-4198, Japan
Shimane University Hospital
Izumo, 693-8501, Japan
Imamura General Hospital
Kagoshima, 890-0064, Japan
Kagoshima University Hospital
Kagoshima, 890-8544, Japan
Izuro Imamura Hospital
Kagoshima, 892-0824, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
Sameshima Hospital
Kagoshima, 892-0846, Japan
St Marianna University Hospital
Kanagawa, 216 8511, Japan
Matsushima Hospital
Kanagawa, 220-0041, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, 920-8650, Japan
Nara Medical University Hospital
Kashihara, 634-8522, Japan
The Jikei University Kashiwa Hospital
Kashiwa, 277 -8567, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
Kyushu Rosai Hospital
Kitakyushu, 800-0296, Japan
Kobe University Hospital
Kobe, 650 0017, Japan
Aoyama Naika Clinic
Kobe, 650-0015, Japan
National Hospital Organization Kochi National Hospital
Kochi, 780-8077, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-8506, Japan
Kumagaya General Hospital
Kumagaya-shi, 360-8567, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, 736-0023, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701, Japan
National Hospital Organization Tokyo Medical Center
Meguro Ku, 152 8902, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Takagi Clinic
Miyagi, 981-3213, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, 020-8505, Japan
Nagoya University Hospital
Nagoya, 466 8560, Japan
Nagoya City University Hospital
Nagoya, 467 8602, Japan
Nagaoka Chuo General Hospital
Niigata, 940-8653, Japan
Hyogo Medical University Hospital
Nishinomiya Shi, 663 8501, Japan
Nakagami Hospital
Okinawa, 904-2195, Japan
Japanese Red Cross Osaka Hospital
Osaka, 543-8555, Japan
Osaka Metropolitan University Hospital
Osaka, 545 8586, Japan
Izumiotsu Municipal Hospital
Osaka, 595-0027, Japan
Oita Red Cross Hospital
Ōita, 870-0033, Japan
Shinbeppu Hospital
Ōita, 874-8538, Japan
Osaki Citizen Hospital
Ōsaki, 989-6183, Japan
Japan Community Health Care Organization Saitama Medical Center
Saitama, 330-0074, Japan
Kindai University Hospital
Sakai, 590 0197, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Sapporo Tokushukai Hospital
Sapporo, 004-0041, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 060-0033, Japan
Sapporo Medical University Hospital
Sapporo, 060-8543, Japan
Sapporo IBD Clinic
Sapporo, 064-0919, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
Tokyo Yamate Medical Center
Shinjuku-ku, 169-0073, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575, Japan
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
The Jikei University Hospital
Tokyo, 105 8471, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Yokkaichi Hazu Medical Center
Yokkaichi, 510-0016, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 221 0855, Japan
University of Fukui Hospital
Yoshida, 910-1193, Japan
Jordan University Hospital
Amman, 11942, Jordan
Istishari Hospital
Amman, Jordan
Khalidi Hospital and Medical Center
Amman, Jordan
Irbid Specialty Hospital
Irbid, 21166, Jordan
King Abdullah University Hospital
Irbid, 22110, Jordan
Pauls Stradins Clinical University Hospital 1
Riga, LV-1002, Latvia
Pauls Stradins Clinical University Hospital
Riga, LV1002, Latvia
Health Centre 4 Centre of Diagnostics
Riga, LV1003, Latvia
Digestive Diseases Centre GASTRO
Riga, LV1079, Latvia
Hospital Serdang
Kajang, 43000, Malaysia
Hospital University Sains Malaysia
Kelantan, 16150, Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, 56000, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Dunedin Hospital
Dunedin, 9016, New Zealand
Auckland City Hospital
Grafton, 1023, New Zealand
Waikato Hospital
Hamilton, 3204, New Zealand
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok, 15-322, Poland
Centrum Medyczne Medis
Bydgoszcz, 85 229, Poland
Centrum Medyczne Plejady
Krakow, 30 363, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
Gastromed ZOZ
Lublin, 20-583, Poland
Medicome Sp z o.o.
Oświęcim, 32-600, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
Endoskopia Sp z o.o.
Sopot, 81-756, Poland
Uromed Jakub Koteras Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
GASTROMED Sp. z o.o.
Torun, 87 100, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, 02-507, Poland
Wojskowy Instytut Medyczny
Warsaw, 04 349, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04 501, Poland
Wro Medica
Wroclaw, 51-685, Poland
Melita Medical Sp. z o.o.
Wroclaw, 53 611, Poland
ETG Zamosc
Zamość, 22 400, Poland
Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075, Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, 4099 001, Portugal
Uls Sao Joao - Hosp. Sao Joao
Porto, 4200 319, Portugal
Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao
Santa Maria da Feira, 4520-211, Portugal
Centro Hospitalar de Tondela Viseu, EPE
Viseu, 3504-509, Portugal
Immanuel Kant Baltic Federal University
Kaliningrad, 236016, Russia
Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways
Nizhny Novgorod, 603140, Russia
Medical Center SibNovoMed LLC
Novosibirsk, 630005, Russia
LLC 'Novosibirsk Gastrocentr'
Novosibirsk, 630007, Russia
City Clinical Hospital #2
Perm, 614068, Russia
Rostov State Medical University 1
Rostov-on-Don, 344022, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
International Medical Centre SOGAZ
Saint Petersburg, 191186, Russia
All-Russian Center of Emergency and Radiation Medicine MCRS
Saint Petersburg, 194044, Russia
Eco-safety Ltd
Saint Petersburg, 196143, Russia
Medical University Reaviz
Samara, 443001, Russia
NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'
Samara, 443041, Russia
Saratov Regional Clinical Hospital
Saratov, 410053, Russia
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
Ufa, 450005, Russia
City Clinical Hospital # 21
Ufa, 450071, Russia
Regional Clinical Hospital 1
Yaroslavl, 150062, Russia
Medical Center Meditsinskie Tekhnologii
Yekaterinburg, 620075, Russia
OOO MO New Hospital
Yekaterinburg, 620109, Russia
Zvezdara University Medical Center
Belgrade, 11000, Serbia
General Hospital 'Dr Radivoj Simonovic'
Sombor, 25101, Serbia
General Hospital 'Djordje Joanovic'
Zrenjanin, 23000, Serbia
FNsP F.D.R. Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Gastroenterology Department GASTROMART s.r.o.
Bardejov, 085 01, Slovakia
Gastroenterology Center ASSIDUO
Bratislava, 811 08, Slovakia
Cliniq s.r.o.
Bratislava, 811 09, Slovakia
ENDOMED s.r.o
Košice, 040 13, Slovakia
GASTRO I. s.r.o.
Prešov, 080 01, Slovakia
Accout Center, s.r.o., Gastroenterologická ambulancia
Šahy, 93601, Slovakia
Inje University Haeundae Paik Hospital
Busan, 612-896, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
KyungHee University Hospital
Seoul, 02447, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Univ. Dr. Josep Trueta
Girona, 17007, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Ntra. Sra. de Valme
Seville, 41014, Spain
Karolinska Universitetssjukhuset
Stockholm, SE-171 76, Sweden
Uppsala University
Uppsala, SE 75185, Sweden
Chang-Hua Christian Hospital
Changhua, 50006, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, 33305, Taiwan
Hacettepe University Hospital
Ankara, 06230, Turkey (Türkiye)
Gazi University Hospital
Ankara, 06560, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Medicana International Istanbul
Istanbul, 34520, Turkey (Türkiye)
BAU Medical Park Goztepe Hospital
Istanbul, 34732, Turkey (Türkiye)
Acibadem Kozyatagi Hospital
Istanbul, 34734, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, 35330, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty Hospital
Mersin, 33110, Turkey (Türkiye)
Municipal Non-Profit Enterprise Ivano Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008, Ukraine
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
Kharkiv, 61037, Ukraine
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
Kharkiv, 61039, Ukraine
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
Kherson, 73003, Ukraine
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
Kyiv, 02091, Ukraine
MC PE Sygma
Kyiv, 04116, Ukraine
Limited Liability Company Progastro Clinic
Lviv, 79019, Ukraine
Kalyna Center of Modern Medicine
Lviv, 79034, Ukraine
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odesa, 65025, Ukraine
Sumy Regional Clinical Hospital a Non-profit Enterprise of Sumy Regional Council
Sumy, 40022, Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, 46002, Ukraine
Health Clinic Limited Liability Company
Vinnytsia, 21009, Ukraine
Municipal Non-Profit Enterprise M I Pyrohov Vinnytsia Regional Clinical Hospital
Vinnytsia, 21018, Ukraine
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Guy's and St Thomas' Hospital
London, SE1 7EH, United Kingdom
St Georges Hospital
London, SW17 0QT, United Kingdom
Related Publications (4)
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.
PMID: 41871904DERIVEDChen 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.
PMID: 40574492DERIVEDRubin 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.
PMID: 39706209DERIVEDPeyrin-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.
PMID: 37659673DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director IMM
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 26, 2019
Study Start
September 26, 2019
Primary Completion
September 19, 2023
Study Completion (Estimated)
September 29, 2027
Last Updated
June 5, 2026
Results First Posted
November 18, 2024
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
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