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

Recruitment Status: ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified March 2026 by Janssen Research & Development, LLC
Sponsor: Janssen Research & Development, LLC
Information Provided by (Responsible Party): Janssen Research & Development, LLC

Clinicaltrials.gov Identifier: NCT04033445
Other Study ID Numbers:: CR108657

First Submitted: July 23, 2019
First Posted: July 25, 2019
Results First Posted: September 17, 2024
Last Update Posted: April 12, 2026
Last Verified: March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Ulcerative Colitis	Drug: GuselkumabDrug: GuselkumabDrug: PlaceboDrug: GuselkumabDrug: PlaceboDrug: GuselkumabDrug: GuselkumabDrug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	1064 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
Official Title	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
Study Start Date	September 25, 2019
Actual Primary Completion Date	September 18, 2023
Actual Study Completion Date	1yr 4mos from now

Groups and Cohorts

Group/Cohort	Intervention/Treatment
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.
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.
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.
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.
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.
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.
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.
Maintenance Study: Placebo SC Participants will receive matching placebo SC q4w.	Drug: Placebo Participants will receive matching placebo IV or SC.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12
Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12
Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12
Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12
Induction Study 2: Percentage of Participants With Clinical Response at Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4
Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12
Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12
Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2
Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12
Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44
Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44
Maintenance Study: Percentage of Participants With Clinical Response at Week M-44
Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44
Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44
Maintenance Study: Percentage of Participants With Fatigue Response 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
Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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

Contacts and Locations

Sponsors and Collaborators	Janssen Research & Development, LLC
Locations	Om Research LLC \| Lancaster California, United States, 93534UCLA \| Los Angeles California, United States, 90095Peak Gastroenterology Associates 1 \| Colorado Springs Colorado, United States, 80907Florida Research Network, LLC \| Gainesville Florida, United States, 32605University of Florida Health Jacksonville \| Gainesville Florida, United States, 32608Harmony Medical Research Institute, Inc. \| Hialeah Florida, United States, 33016UF Health Jacksonville Gastroenterology Emerson \| Jacksonville Florida, United States, 32209I.H.S. Health. LLC \| Kissimmee Florida, United States, 34741Columbus Clinical Services LLC \| Miami Florida, United States, 33125Vista Health Research, LLC \| Miami Florida, United States, 33155Orlando Health \| Orlando Florida, United States, 32806Care Access Research, Orlando \| Orlando Florida, United States, 32825Synexus Clinical Research US Inc 2 \| Pinellas Park Florida, United States, 33781Univ. of South Florida Med. Group \| Tampa Florida, United States, 33606Atlanta Gastroenterology Associates \| Atlanta Georgia, United States, 30224Morehouse School of Medicine \| Atlanta Georgia, United States, 30310The Emory Clinic \| Atlanta Georgia, United States, 30322Atlanta Gastroenterology Associates 1 \| Atlanta Georgia, United States, 30342Atlanta Center For Gastroenterology \| Decatur Georgia, United States, 30033Gastroenterolgy Associates of Central GA \| Macon Georgia, United States, 31201University of Chicago \| Chicago Illinois, United States, 60637Health Science Research Center \| Pratt Kansas, United States, 67124Tri-State Gastroenterology Assoc \| Crestview Hills Kentucky, United States, 41017Baystate Medical Center \| Springfield Massachusetts, United States, 01199Clinical Research Institute of Michigan, LLC \| Clinton Township Michigan, United States, 48038Revive Research Institute \| Farmington Hills Michigan, United States, 48334Infusion Associates \| Grand Rapids Michigan, United States, 49525Mid-America Gastro-Intestinal Consultants \| Kansas City Missouri, United States, 64111Barnes-jewish Hospital \| St Louis Missouri, United States, 63108Las Vegas Medical Research \| Las Vegas Nevada, United States, 89113University of North Carolina at Chapel Hill \| Chapel Hill North Carolina, United States, 27514Duke University Hospital Medical Center \| Raleigh North Carolina, United States, 27609Synexus Clinical Research US Inc \| Columbus Ohio, United States, 43212Digestive Specialists, Inc \| Springboro Ohio, United States, 45066Gastro Intestinal Research Institute of Northern Ohio LLC \| Westlake Ohio, United States, 44145Care Access Research, Poland \| Youngstown Ohio, United States, 44514Digestive Disease Specialists Inc \| Oklahoma City Oklahoma, United States, 73114US Digestive Health \| Wyomissing Pennsylvania, United States, 19610Synexus Clinical Research US Inc 1 \| Anderson South Carolina, United States, 29621-2062Gastroenterology Associates of Orangeburg, SC \| Orangeburg South Carolina, United States, 29118Erlanger Health System \| Chattanooga Tennessee, United States, 37403Vanderbilt University Medical Center \| Nashville Tennessee, United States, 37212Baylor College of Medicine \| Houston Texas, United States, 77030Caprock Gastro Research \| Lubbock Texas, United States, 79424Tyler Research Institute, LLC \| Tyler Texas, United States, 75701Care Access Research, Ogden \| Ogden Utah, United States, 84403Care Access Research- Salt Lake City \| Salt Lake City Utah, United States, 84124Gastroenterology Associates of Tidewater \| Chesapeake Virginia, United States, 23320UW-Harborview Medical Center \| Seattle Washington, United States, 98104Providence Medical Group \| Spokane Washington, United States, 99208Velocity Clinical Research Spokane \| Spokane Washington, United States, 99218Care Access Research, Casper \| Casper Wyoming, United States, 10456CEMIC (Centro de Educación Médica e Investigaciones Clínicas) \| Buenos Aires , Argentina, 1431Cer Instituto Medico \| Buenos Aires , Argentina, 1878CINME Centro de Investigaciones Metabolicas \| Buenos Aires , Argentina, C1056ABIHospital General de Agudos José Maria Ramos Mejía \| Buenos Aires , Argentina, C1221ADCCentro Médico Dra. De Salvo \| Caba , Argentina, C1426ABPClinica Adventista Belgrano \| Ciudad de Buenos Aires , Argentina, C1430EGFSanatorio Duarte Quiroz \| Córdoba , Argentina, X5002AOQCentro de Investigaciones Medicas Mar Del Plata \| Mar del Plata , Argentina, B7600FYKFundacion de Estudios Clinicos \| Rosario , Argentina, 2000Hospital Provincial del Centenario \| Rosario , Argentina, S2000KDSHospital de Alta Complejidad en Red 'El Cruce' \| San Juan Bautista , Argentina, 1888Emeritus Research \| Camberwell , Australia, 3124Monash Health \| Clayton , Australia, 3168Western Health \| Footscray , Australia, 3011Fiona Stanley Hospital \| Murdoch , Australia, 6150Royal Perth Hospital \| Perth , Australia, 6000Mater Hospital \| South Brisbane , Australia, 4101St John of God Subiaco Hospital \| Subiaco , Australia, 6008Princess Alexandra Hospital \| Woolloongabba , Australia, 4102Universitaetsklinikum Salzburg Landeskrankenhaus \| Salzburg , Austria, 5020AZ Sint Lucas 1 \| Bruges , Belgium, 8310CHU Saint-Pierre \| Brussels , Belgium, 1000Hopital Erasme \| Brussels , Belgium, 1070AZ Maria Middelares \| Ghent , Belgium, 9000Universitair Ziekenhuis Gent \| Ghent , Belgium, 9000Algemeen Ziekenhuis Jan Palfijn Merksem \| Merksem , Belgium, 2170Algemeen Ziekenhuis Delta \| Roeselare , Belgium, 8800L2IP Instituto de Pesquisas Clinicas \| Brasília , Brazil, 70200 730Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro \| Campinas , Brazil, 13060-904CDC - Centro Digestivo de Curitiba \| Curitiba , Brazil, 80430-180Galileo Pesquisa Clinica \| Juiz de Fora , Brazil, 36033 318Instituto Mederi de Pesquisa e Saude \| Passo Fundo , Brazil, 99010-120Hospital das Clinicas de Porto Alegre \| Porto Alegre , Brazil, 90035-903NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul \| Porto Alegre , Brazil, 90430-001Universidade Federal do Rio de Janeiro - Faculdade de Medicina \| Rio de Janeiro , Brazil, 21941-913CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao \| Salvador , Brazil, 41500-300CPQuali Pesquisa Clinica LTDA ME \| São Paulo , Brazil, 01228-900BR Trials \| São Paulo , Brazil, 01236030Instituto D Or de Pesquisa e Ensino IDOR \| São Paulo , Brazil, 01401 002Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui \| Teresina , Brazil, 64049-550Eurolatino Pesquisas Medicas Ltda \| Uberlândia , Brazil, 38400-368Medical Centre Asklepii OOD \| Dupnitsa , Bulgaria, 2600Medical Center-1-Sevlievo EOOD \| Sevlievo , Bulgaria, 54002-nd MHAT \| Sofia , Bulgaria, 12024th MHAT - Sofia \| Sofia , Bulgaria, 1606DCC Convex EOOD \| Sofia , Bulgaria, 1680Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD \| Sofia , Bulgaria, 1784MHAT 'St. Marina' EAD \| Varna , Bulgaria, 9010MHAT Dr Stefan Cherkezov \| Veliko Tarnovo , Bulgaria, 5000G I R I GI Research Institute Foundation \| Vancouver British Columbia, Canada, V6Z 2K5Health Sciences Centre \| Winnipeg Manitoba, Canada, R3A 1R9Barrie GI Associates \| Barrie Ontario, Canada, L4M 7G1Toronto Immune and Digestive Health Institute Inc \| Toronto Ontario, Canada, M6A 3B4Hopital Maisonneuve Rosemont \| Montreal Quebec, Canada, H1T 2M4Royal University Hospital \| Saskatoon Saskatchewan, Canada, S7N 0W8Capital Medical University, Beijing Friendship Hospital \| Beijing , China, 100050Peking University Third Hospital \| Beijing , China, 100191China-Japan Union Hospital of Jilin University \| Changchun , China, 130033The second Xiangya Hospital of Central South University \| Changsha , China, 200120The Third Xiangya Hospital of Central Sourth University \| Changsha , China, 40013West China Hospital of Sichuan University \| Chengdu , China, 610041Daping Hospital \| Chongqing , China, 400042The Second Hospital To Dalian Medical University \| Dalian , China, 116027First Affiliated Hospital of Gannan Medical University \| Ganzhou , China, 341000The First Affiliated Hospital Sun Yat sen University \| Guangzhou , China, 510080The Sixth Affiliated Hospital Sun Yat sen University \| Guangzhou , China, 510610The First Affiliated Hospital Zhejiang University College of Medicine \| Hangzhou , China, 310003The Second Affiliated Hospital of Zhejiang University \| Hangzhou , China, 310009Sir Run Run Shaw Hospital Zhejiang University School of Medicine \| Hangzhou , China, 310016The First Affiliated Hospital of Anhui Medical University \| Hefei , China, 230022First Affiliated Hospital of Kunming Medical Unversity \| Kunming , China, 650032The First Affiliated Hospital of NanChang University \| Nanchang , China, 330006Nanjing Drum Tower Hospital \| Nanjing , China, 210008Zhongda Hospital Southeast University \| Nanjing , China, 210009Jiangsu Province Hospital \| Nanjing , China, 210029Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine \| Shanghai , China, 200025Shengjing Hospital Of China Medical University \| Shenyang , China, 110004The Second Hospital Affiliated To Suzhou University \| Suzhou , China, 215168The first affiliated hospital of suzhou University \| Suzhou , China, Tianjin Medical University General Hospital \| Tianjin , China, 300011Wuhan Union Hospital \| Wuhan , China, 430022Tongji Hospital, Tongji Medical College of HUST \| Wuhan , China, 430030Wuxi People s Hospital \| Wuxi , China, 214023Nemocnice Ceske Budejovice a s \| České Budějovice , Czechia, 37001Endohope Havirov s.r.o. \| Havířov , Czechia, 736 01Gastroenterologie, s.r.o., Hradec Kralove \| Hradec Kralova , Czechia, 500 02MUDr. Gregar s.r.o. \| Olomouc , Czechia, 779 00Vitkovicka nemocnice a.s. \| Ostrava , Czechia, 703 84Artroscan s r o \| Ostrava , Czechia, 722 00Synexus Czech s.r.o. \| Prague , Czechia, 120 00ResTrial GastroEndo, s.r.o \| Prague , Czechia, 143 00Nemocnice na Homolce \| Prague , Czechia, 150 30AXON Clinical s.r.o. \| Prague , Czechia, 15000ISCARE a.s. \| Prague , Czechia, 190 00Nemocnice Strakonice, a.s. \| Strakonice , Czechia, 386 29CHU caen \| Caen , France, 14033Hopital Beaujon \| Clichy , France, 92110CHRU de Lille Hopital Claude Huriez \| Lille , France, 59000Hopital Saint Eloi \| Montpellier , France, 34295CHU de Nice Hopital de l Archet \| Nice , France, 62002Hopital Saint Antoine \| Paris , France, 75571Hopital Haut-Leveque, CMC Magellan \| Pessac , France, 33604Centre Hospitalier Lyon Sud \| Pierre-Bénite , France, 69495CHU Saint Etienne Hopital Nord \| Saint-Priest-en-Jarez , France, 42270Nouvel Hopital Civil \| Strasbourg , France, 67091CHU Rangueil \| Toulouse , France, 31059CHRU Nancy Brabois \| Vandœuvre-lès-Nancy , France, 54511Universitaetsklinikum Charite, Campus Virchow Klinikum \| Berlin , Germany, 13353BSF Studiengesellschaft \| Halle , Germany, 06108Medizinische Hochschule Hannover \| Hanover , Germany, 30625Praxisgemeinschaft Jerichow \| Jerichow , Germany, 39319Staedtisches Klinikum Lueneburg \| Lüneburg , Germany, 21339Zentrum für Gastroenterologie Saar MVZ GmbH \| Saarbrücken , Germany, 66111Universitaetsklinikum Ulm \| Ulm , Germany, 89081Synexus Magyarorszag Kft \| Budapest , Hungary, 1036Magyar Honvedseg Egeszsegugyi Kozpont \| Budapest , Hungary, 1062Semmelweis University 1 \| Budapest , Hungary, 1082Semmelweis University \| Budapest , Hungary, 1088Vasutegeszsegugyi Nonprofit Kozhasznu Kft \| Debrecen , Hungary, 4025Debreceni Egyetem Klinikai Kozpont \| Debrecen , Hungary, H-4032Gyongyosi Bugat Pal Korhaz \| Gyöngyös , Hungary, 3200Synexus Magyarorszag Kft 1 \| Gyula , Hungary, 5700Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika \| Szeged , Hungary, 6725Beaumont Hospital \| Dublin , Ireland, 9St Vincent's University Hospital \| Dublin , Ireland, D04T6F4University Hospital Galway - Ireland \| Galway , Ireland, H91YR71Rambam Medical Center \| Haifa , Israel, 31096Bnai Zion Medical Center \| Haifa , Israel, 3449419Wolfson Medical Center \| Holon , Israel, 58100Shaare Zedek Medical Center \| Jerusalem , Israel, 91031Lev Talpiot Clinic \| Jerusalem , Israel, 93624Galilee Medical Center \| Nahariya , Israel, 2210001Tel Aviv Sourasky Medical Center \| Tel Aviv , Israel, 6423914Policlinico Sant'Orsola Malpighi \| Bologna , Italy, 40138Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico \| Milan , Italy, 20122Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar \| Negrar , Italy, 37024Azienda Ospedaliera di Padova \| Padova , Italy, 35128Ospedale Villa Sofia-Cervello \| Palermo , Italy, 90146Azienda Ospedaliera G.Salvini Ospedale di Rho \| Rho , Italy, Università Campus Biomedico di Roma \| Roma , Italy, 00128Fondazione Policlinico Gemelli Università Cattolica \| Roma , Italy, 00168Istituto Clinico Humanitas Rozzano, IRCCS \| Rozzano , Italy, 20089Casa Sollievo Della Sofferenza IRCCS \| San Giovanni Rotondo , Italy, 71013AO Ordine Mauriziano \| Torino , Italy, 10128Institute of Science Tokyo Hospital \| Bunkyō City , Japan, 113 8519Juntendo University Hospital Urayasu \| Chiba , Japan, 279 0021Fukuoka University Chikushi Hospital \| Chikushino-shi , Japan, 818-8502Ehime Prefectural Central Hospital \| Ehime , Japan, 790-0024Sai Gastroenterology Proctology \| Fujiidera-shi , Japan, 583-0027Fukuoka University Hospital \| Fukuoka , Japan, 814-0180Kitakyushu Municipal Medical Center \| Fukuoka-ken , Japan, 802-0077Fukushima Medical University Hospital \| Fukushima , Japan, 960 1295Gifu University Hospital \| Gifu , Japan, 501-1194Hachinohe City Hospital \| Hachinohe , Japan, 031-8555Tokai University Hachioji Hospital \| Hachiōji , Japan, 192-0032Hakodate Goryoukaku Hospital \| Hakodate , Japan, 040 8611Matsuda Hospital \| Hamamatsu , Japan, 432-8061Matsunami General Hospital \| Hashima-gun , Japan, 501-6062National Hospital Organization Hirosaki General Medical Center \| Hirosaki , Japan, 036-8545Hirosaki University Hospital \| Hirosaki , Japan, 036-8563Kure Kyosai Hospital \| Hiroshima , Japan, 737-8505Asahikawa Medical University Hospital \| Hokkaido , Japan, 078 8510Mito Saiseikai General Hospital \| Ibaraki , Japan, 311-4198Shimane University Hospital \| Izumo , Japan, 693-8501Imamura General Hospital \| Kagoshima , Japan, 890-0064Kagoshima University Hospital \| Kagoshima , Japan, 890-8544Izuro Imamura Hospital \| Kagoshima , Japan, 892-0824Kagoshima IBD Gastroenterology Clinic \| Kagoshima , Japan, 892-0843Sameshima Hospital \| Kagoshima , Japan, 892-0846St Marianna University Hospital \| Kanagawa , Japan, 216 8511Matsushima Hospital \| Kanagawa , Japan, 220-0041Kanazawa University Hospital \| Kanazawa , Japan, 920 8641National Hospital Organization Kanazawa Medical Center \| Kanazawa , Japan, 920-8650Nara Medical University Hospital \| Kashihara , Japan, 634-8522The Jikei University Kashiwa Hospital \| Kashiwa , Japan, 277 -8567Tsujinaka Hospital Kashiwanoha \| Kashiwa , Japan, 277-0871Kyushu Rosai Hospital \| Kitakyushu , Japan, 800-0296Kobe University Hospital \| Kobe , Japan, 650 0017Aoyama Naika Clinic \| Kobe , Japan, 650-0015National Hospital Organization Kochi National Hospital \| Kochi , Japan, 780-8077Yamanashi Prefectural Central Hospital \| Kofu , Japan, 400-8506Kumagaya General Hospital \| Kumagaya-shi , Japan, 360-8567National Hospital Organization Kure Medical Center and Chugoku Cancer Center \| Kure , Japan, 736-0023University Hospital Kyoto Prefectural University of Medicine \| Kyoto , Japan, 602-8566National Hospital Organization Matsumoto Medical Center \| Matsumoto , Japan, 399-8701National Hospital Organization Tokyo Medical Center \| Meguro Ku , Japan, 152 8902Kitasato University Kitasato Institute Hospital \| Minatoku , Japan, 108-8642Kyorin University Hospital \| Mitaka , Japan, 181-8611Takagi Clinic \| Miyagi , Japan, 981-3213Iwate Medical University Uchimaru Medical Center \| Morioka , Japan, 020-8505Nagoya University Hospital \| Nagoya , Japan, 466 8560Nagoya City University Hospital \| Nagoya , Japan, 467 8602Nagaoka Chuo General Hospital \| Niigata , Japan, 940-8653Hyogo Medical University Hospital \| Nishinomiya Shi , Japan, 663 8501Nakagami Hospital \| Okinawa , Japan, 904-2195Japanese Red Cross Osaka Hospital \| Osaka , Japan, 543-8555Osaka Metropolitan University Hospital \| Osaka , Japan, 545 8586Izumiotsu Municipal Hospital \| Osaka , Japan, 595-0027Oita Red Cross Hospital \| Ōita , Japan, 870-0033Shinbeppu Hospital \| Ōita , Japan, 874-8538Osaki Citizen Hospital \| Ōsaki , Japan, 989-6183Japan Community Health Care Organization Saitama Medical Center \| Saitama , Japan, 330-0074Kindai University Hospital \| Sakai , Japan, 590 0197Toho University Sakura Medical Center \| Sakura , Japan, 285-8741Sapporo Tokushukai Hospital \| Sapporo , Japan, 004-0041Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital \| Sapporo , Japan, 060-0033Sapporo Medical University Hospital \| Sapporo , Japan, 060-8543Sapporo IBD Clinic \| Sapporo , Japan, 064-0919Sapporo Higashi Tokushukai Hospital \| Sapporo , Japan, 065-0033Tokyo Yamate Medical Center \| Shinjuku-ku , Japan, 169-0073Tokyo Metropolitan Bokutoh Hospital \| Sumida Ku , Japan, 130 8575Kagawa Prefectural Central Hospital \| Takamatsu , Japan, 760-8557Tokushima University Hospital \| Tokushima , Japan, 770-8503The Jikei University Hospital \| Tokyo , Japan, 105 8471Mie University Hospital \| Tsu , Japan, 514-8507Yokkaichi Hazu Medical Center \| Yokkaichi , Japan, 510-0016Yokohama Municipal Citizen's Hospital \| Yokohama , Japan, 221 0855University of Fukui Hospital \| Yoshida , Japan, 910-1193Jordan University Hospital \| Amman , Jordan, 11942Istishari Hospital \| Amman , Jordan, Khalidi Hospital and Medical Center \| Amman , Jordan, Irbid Specialty Hospital \| Irbid , Jordan, 21166King Abdullah University Hospital \| Irbid , Jordan, 22110Pauls Stradins Clinical University Hospital 1 \| Riga , Latvia, LV-1002Pauls Stradins Clinical University Hospital \| Riga , Latvia, LV1002Health Centre 4 Centre of Diagnostics \| Riga , Latvia, LV1003Digestive Diseases Centre GASTRO \| Riga , Latvia, LV1079Hospital Serdang \| Kajang , Malaysia, 43000Hospital University Sains Malaysia \| Kelantan , Malaysia, 16150Pusat Perubatan Universiti Kebangsaan Malaysia \| Kuala Lumpur , Malaysia, 56000University Malaya Medical Centre \| Kuala Lumpur , Malaysia, 59100Onze Lieve Vrouwe Gasthuis \| Amsterdam , Netherlands, 1091 ACAlbert Schweitzer Ziekenhuis \| Dordrecht , Netherlands, 3318 ATRadboudumc \| Nijmegen , Netherlands, 6525 GADunedin Hospital \| Dunedin , New Zealand, 9016Auckland City Hospital \| Grafton , New Zealand, 1023Waikato Hospital \| Hamilton , New Zealand, 3204Gastromed Kralisz Romatowski Stachurska Sp. j. \| Bialystok , Poland, 15-322Centrum Medyczne Medis \| Bydgoszcz , Poland, 85 229Centrum Medyczne Plejady \| Krakow , Poland, 30 363Centrum Medyczne Promed \| Krakow , Poland, 31-513Gastromed ZOZ \| Lublin , Poland, 20-583Medicome Sp z o.o. \| Oświęcim , Poland, 32-600Centrum Medyczne Medyk \| Rzeszów , Poland, 35-326Endoskopia Sp z o.o. \| Sopot , Poland, 81-756Uromed Jakub Koteras Twoja Przychodnia - Szczecinskie Centrum Medyczne \| Szczecin , Poland, 71-434GASTROMED Sp. z o.o. \| Torun , Poland, 87 100Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji \| Warsaw , Poland, 02-507Wojskowy Instytut Medyczny \| Warsaw , Poland, 04 349WIP Warsaw IBD Point Profesor Kierkus \| Warsaw , Poland, 04 501Wro Medica \| Wroclaw , Poland, 51-685Melita Medical Sp. z o.o. \| Wroclaw , Poland, 53 611ETG Zamosc \| Zamość , Poland, 22 400Centro Hospitalar e Universitário de Coimbra, EPE \| Coimbra , Portugal, 3000-075Uls Santo Antonio - Hosp. Santo Antonio \| Porto , Portugal, 4099 001Uls Sao Joao - Hosp. Sao Joao \| Porto , Portugal, 4200 319Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao \| Santa Maria da Feira , Portugal, 4520-211Centro Hospitalar de Tondela Viseu, EPE \| Viseu , Portugal, 3504-509Immanuel Kant Baltic Federal University \| Kaliningrad , Russia, 236016Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways \| Nizhny Novgorod , Russia, 603140Medical Center SibNovoMed LLC \| Novosibirsk , Russia, 630005LLC 'Novosibirsk Gastrocentr' \| Novosibirsk , Russia, 630007City Clinical Hospital #2 \| Perm , Russia, 614068Rostov State Medical University 1 \| Rostov-on-Don , Russia, 344022Rostov State Medical University \| Rostov-on-Don , Russia, 344022International Medical Centre SOGAZ \| Saint Petersburg , Russia, 191186All-Russian Center of Emergency and Radiation Medicine MCRS \| Saint Petersburg , Russia, 194044Eco-safety Ltd \| Saint Petersburg , Russia, 196143Medical University Reaviz \| Samara , Russia, 443001NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways' \| Samara , Russia, 443041Saratov Regional Clinical Hospital \| Saratov , Russia, 410053GBUZ Respublican Clinical Hospital n.a. GG Kuvatova \| Ufa , Russia, 450005City Clinical Hospital # 21 \| Ufa , Russia, 450071Regional Clinical Hospital 1 \| Yaroslavl , Russia, 150062Medical Center Meditsinskie Tekhnologii \| Yekaterinburg , Russia, 620075OOO MO New Hospital \| Yekaterinburg , Russia, 620109Zvezdara University Medical Center \| Belgrade , Serbia, 11000General Hospital 'Dr Radivoj Simonovic' \| Sombor , Serbia, 25101General Hospital 'Djordje Joanovic' \| Zrenjanin , Serbia, 23000FNsP F.D.R. Banska Bystrica \| Banská Bystrica , Slovakia, 975 17Gastroenterology Department GASTROMART s.r.o. \| Bardejov , Slovakia, 085 01Gastroenterology Center ASSIDUO \| Bratislava , Slovakia, 811 08Cliniq s.r.o. \| Bratislava , Slovakia, 811 09ENDOMED s.r.o \| Košice , Slovakia, 040 13GASTRO I. s.r.o. \| Prešov , Slovakia, 080 01Accout Center, s.r.o., Gastroenterologická ambulancia \| Šahy , Slovakia, 93601Inje University Haeundae Paik Hospital \| Busan , South Korea, 612-896Yeungnam University Hospital \| Daegu , South Korea, 42415Korea University Ansan Hospital \| Gyeonggi-do , South Korea, 15355The Catholic university of Korea, St. Vincent's Hospital \| Gyeonggi-do , South Korea, 16247Gachon University Gil Medical Center \| Incheon , South Korea, 21565Seoul National University Bundang Hospital \| Seongnam-si , South Korea, 13620KyungHee University Hospital \| Seoul , South Korea, 02447Severance Hospital Yonsei University Health System \| Seoul , South Korea, 03722Asan Medical Center \| Seoul , South Korea, 05505Samsung Medical Center \| Seoul , South Korea, 06351The Catholic University of Korea Seoul St Mary s Hospital \| Seoul , South Korea, 06591Chung-Ang University Hospital \| Seoul , South Korea, 06973Ajou University Hospital \| Suwon , South Korea, 16499Hosp. Univ. Germans Trias I Pujol \| Badalona , Spain, 08916Hosp Clinic de Barcelona \| Barcelona , Spain, 08036Hosp. Univ. Dr. Josep Trueta \| Girona , Spain, 17007Hosp. Univ. La Paz \| Madrid , Spain, 28046Hosp. Univ. Marques de Valdecilla \| Santander , Spain, 39008Hosp. Virgen Del Rocio \| Seville , Spain, 41013Hosp. Ntra. Sra. de Valme \| Seville , Spain, 41014Karolinska Universitetssjukhuset \| Stockholm , Sweden, SE-171 76Uppsala University \| Uppsala , Sweden, SE 75185Chang-Hua Christian Hospital \| Changhua , Taiwan, 50006Taichung Veterans General Hospital \| Taichung , Taiwan, 40705National Taiwan University Hospital \| Taipei , Taiwan, 10002Chang-Gung Memorial Hospital, LinKou Branch \| Taoyuan , Taiwan, 33305Hacettepe University Hospital \| Ankara , Turkey (Türkiye), 06230Gazi University Hospital \| Ankara , Turkey (Türkiye), 06560Trakya University Medical Faculty \| Edirne , Turkey (Türkiye), 22030Istanbul University Istanbul Medical Faculty \| Istanbul , Turkey (Türkiye), 34093Istanbul University Cerrahpasa Medical Faculty \| Istanbul , Turkey (Türkiye), 34098Medicana International Istanbul \| Istanbul , Turkey (Türkiye), 34520BAU Medical Park Goztepe Hospital \| Istanbul , Turkey (Türkiye), 34732Acibadem Kozyatagi Hospital \| Istanbul , Turkey (Türkiye), 34734Ege University Medical Faculty \| Izmir , Turkey (Türkiye), 35100Dokuz Eylul University Medical Faculty \| Izmir , Turkey (Türkiye), 35330Kocaeli University Medical Faculty \| Kocaeli , Turkey (Türkiye), 41380Mersin University Medical Faculty Hospital \| Mersin , Turkey (Türkiye), 33110Municipal Non-Profit Enterprise Ivano Frankivsk Regional Clinical Hospital \| Ivano-Frankivsk , Ukraine, 76008Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov' \| Kharkiv , Ukraine, 61037SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine \| Kharkiv , Ukraine, 61039Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh' \| Kherson , Ukraine, 73003Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' \| Kyiv , Ukraine, 02091MC PE Sygma \| Kyiv , Ukraine, 04116Limited Liability Company Progastro Clinic \| Lviv , Ukraine, 79019Kalyna Center of Modern Medicine \| Lviv , Ukraine, 79034Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council \| Odesa , Ukraine, 65025Sumy Regional Clinical Hospital a Non-profit Enterprise of Sumy Regional Council \| Sumy , Ukraine, 40022Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' \| Ternopil , Ukraine, 46002Health Clinic Limited Liability Company \| Vinnytsia , Ukraine, 21009Municipal Non-Profit Enterprise M I Pyrohov Vinnytsia Regional Clinical Hospital \| Vinnytsia , Ukraine, 21018Glasgow Royal Infirmary \| Glasgow , United Kingdom, G4 0SFGuy's and St Thomas' Hospital \| London , United Kingdom, SE1 7EHSt Georges Hospital \| London , United Kingdom, SW17 0QT
Investigators	Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full Text)

Documents provided by Janssen Research & Development, LLC: Study Protocol September 11, 2022Documents provided by Janssen Research & Development, LLC: Statistical Analysis Plan September 7, 2023

More Information

Publications

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. 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.

Additional Relevant MeSH Terms

Colitis, UlcerativeColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases