A Study of Guselkumab Therapy 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
NCT05528510
Other Study ID Numbers:
CR109228
First Submitted
August 18, 2022
First Posted
September 5, 2022
Results First Posted
October 15, 2025
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 .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Colitis, Ulcerative
Drug: Guselkumab Dose 1Drug: Guselkumab Dose 1Other: Placebo

Study Design

Study TypeInterventional
Actual Enrollment418 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Study Start DateSeptember 12, 2022
Actual Primary Completion DateApril 1, 2024
Actual Study Completion Date2yrs 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered as SC injection.
Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered as SC injection.
Group 3: Placebo
Participants will receive matching placebo SC injection.
Other: Placebo
Placebo will be administered as SC injection.

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants in Clinical Remission at Week 12
    Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
Secondary Outcome Measures
  1. Percentage of Participants in Symptomatic Remission at Week 12
    Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.
  2. Percentage of Participants With Endoscopic Improvement at Week 12
    Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
  3. Percentage of Participants in Clinical Response at Week 12
    Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from 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 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, 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.
  4. Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12
    Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (\<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
  5. Percentage of Participants in Clinical Remission at Week 24
    Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
  6. Percentage of Participants in Symptomatic Remission at Week 24
    Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.
  7. Percentage of Participants With Endoscopic Improvement at Week 24
    Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
  8. Percentage of Participants in Clinical Response at Week 24
    Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by \>= 30% and \>=2 points, with either a \>=1-point decrease from baseline 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, 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Signed informed consent form
18 years of age or older
Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
Moderately to severely active UC as per the modified Mayo score
Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Exclusion Criteria
Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
Receiving prohibited medications and treatments
UC limited to the rectum only
Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
Research Solutions of Arizona | Litchfield Park Arizona, United States, 85340Om Research LLC 1 | Apple Valley California, United States, 92307Om Research LLC | Lancaster California, United States, 93534Medical Associates Research Group, Inc. | San Diego California, United States, 92123Peak Gastroenterology Associates | Colorado Springs Colorado, United States, 80907Gastro Florida | Clearwater Florida, United States, 33762I.H.S. Health. LLC | Kissimmee Florida, United States, 34741Columbus Clinical Services LLC | Miami Florida, United States, 33125Vista Health Research, LLC | Miami Florida, United States, 33176Orlando Health | Orlando Florida, United States, 32806Theia Clincial Research, LLC | Temple Terrace Florida, United States, 34209Digestive Healthcare of Georgia, P.C | Atlanta Georgia, United States, 30309Atlanta Gastroenterology Associates | Atlanta Georgia, United States, 30342Gastroenterology Associates of Central GA | Macon Georgia, United States, 31201Cotton O'Neil Digestive Health Center | Topeka Kansas, United States, 66606Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48047Detroit Clinical Research Center | Farmington Hills Michigan, United States, 48334Smart Medical Research | Hollis New York, United States, 11423University of North Carolina | Chapel Hill North Carolina, United States, 27599-7080Peters Medical Research | High Point North Carolina, United States, 27260Dayton Gastroenterology, Inc | Dayton Ohio, United States, 45415Gastro Intestinal Research Institute of Northern Ohio LLC | Westlake Ohio, United States, 44145Allegheny General Hospital of Research | Pittsburgh Pennsylvania, United States, 15224Frontier Clinical Research | Uniontown Pennsylvania, United States, 15401Gastroenterology Associates of Orangeburg, SC | Orangeburg South Carolina, United States, 29118Southern Star Research Institute, LLC | San Antonio Texas, United States, 78229UT Health Science Center at San Antonio | San Antonio Texas, United States, 78229Tyler Research Institute, LLC | Tyler Texas, United States, 75701Victoria Gastroenterology | Victoria Texas, United States, 77407Care Access Research, Ogden | Ogden Utah, United States, 84403Gastroenterology Associates | Salt Lake City Utah, United States, 84124Gastroenterology Associates of Tidewater | Chesapeake Virginia, United States, 23320Cer Instituto Medico | Buenos Aires , Argentina, B1878DVBHospital General de Agudos José Maria Ramos Mejía | Buenos Aires , Argentina, C1221ADCClinica Adventista Belgrano | Ciudad de Buenos Aires , Argentina, C1430EGFSanatorio Duarte Quiroz | Córdoba , Argentina, X5002AOQHospital Privado Universitario De Cordoba | Córdoba , Argentina, X5016KEHHospital Italiano de La Plata | La Plata , Argentina, B1900AXICentro de Investigaciones Medicas Mar Del Plata | Mar del Plata , Argentina, B7600FYKHospital Provincial del Centenario | Rosario , Argentina, S2000KDSRoyal Adelaide Hospital | Adelaide , Australia, 5000Royal Prince Alfred Hospital | Camperdown , Australia, 2050Monash Health | Clayton , Australia, 3168Royal Brisbane and Women's Hospital | Herston , Australia, 4029Fiona Stanley Hospital | Murdoch , Australia, 6150Royal Melbourne Hospital | Parkville , Australia, 3050IBD Clinical Trials Mater Research | South Brisbane , Australia, 4101The Queen Elizabeth Hospital | Woodville South , Australia, 5011Princess Alexandra Hospital | Woolloongabba , Australia, 4102Onze -Lieve-Vrouwziekenhuis | Aalst , Belgium, 9300CHU Saint-Pierre | Brussels , Belgium, 1000AZ Delta | Roeselare , Belgium, 8800Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu) | Botucatu , Brazil, 18618-687L2IP 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, 80430-180CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda | Jaú , Brazil, 17201 130Galileo Pesquisa Clinica | Juiz de Fora , Brazil, 36033 318Hospital das Clinicas de Porto Alegre | Porto Alegre , Brazil, 90035-903NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre , Brazil, 90430-001CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao | Salvador , Brazil, 41500-300Pesquisare Saude | Santo André , Brazil, 09080-110Kaiser Hospta | São José do Rio Preto , Brazil, 15015-110BR TRIALS Ensaios Clinicos e Consultoria Ltda | São Paulo , Brazil, 01236030Instituto D Or de Pesquisa e Ensino IDOR | São Paulo , Brazil, 01401-002INTEGRAL Pesquisa e Ensino | Votuporanga , Brazil, 15501-405Medical centre Asklepion | Sofia , Bulgaria, 1606DCC Convex EOOD | Sofia , Bulgaria, 1680Medical Center Leo Clinic EOOD | Targovishte , Bulgaria, 7700Fraser Clinical Trials Inc. | New Westminster British Columbia, Canada, V3L 3W4Barrie GI Associates | Barrie Ontario, Canada, L4M 7G1Royal University Hospital | Saskatoon Saskatchewan, Canada, S7N 0W8China Japan Friendship Hospital | Beijing , China, 100029Peking University Third Hospital | Beijing , China, 100191West China Hospital Sichuan University | Chengdu , China, 610041Chongqing General Hospital | Chongqing , China, 400014First Affiliated Hospital of Gannan Medical University | Ganzhou , China, 341000The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou , China, 510260ZhuJiang Hospital of Southern Medical University | Guangzhou , China, 510280The First Affiliated Hospital Zhejiang University College of Medicine | Hangzhou , China, 310003The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou , China, 310009The First Affiliated Hospital of Anhui Medical University | Hefei , China, 230022Jinhua municipal central hospital | Jinhua , China, 321009Lanzhou University Second Hospital | Lanzhou , China, 730030The first affiliated hospital of Henan University of science and technology | Luoyang , China, 471003Nanjing Drum Tower Hospital | Nanjing , China, 210008Zhongda Hospital Southeast University | Nanjing , China, 210009Ruijin Hospital Shanghai Jiao Tong University | Shanghai , China, 200025Shanghai East Hospital | Shanghai , China, 200123Shengjing Hospital Of China Medical University | Shenyang , China, 110004Shenzhen Hospital of Southern Medical University | Shenzhen , China, 518101The Second Hospital of Hebei Medical University | Shijiazhuang , China, 050004Taihe Hospital | Shiyan , China, 442000Renmin Hospital of Wuhan University | Wuhan , China, 430060Wuxi People s Hospital | Wuxi , China, 214023General Hospital of Ningxia Medical Hospital | Yinchuan , China, 750011The Second Affiliated Hospital of Zhengzhou University | Zhengzhou , China, 450014Nemocnice Ceske Budejovice a s | České Budějovice , Czechia, 37001Gastroenterologie, s.r.o., Hradec Kralove | Hradec Kralova , Czechia, 500 02Artroscan s r o | Ostrava , Czechia, 722 00Synexus Czech s.r.o. | Prague , Czechia, 120 00AXON Clinical s.r.o. | Prague , Czechia, 15000ISCARE a.s. | Prague , Czechia, 190 00CHRU Besancon Hopital Jean Minjoz | Besançon , France, 25030Hopital de Bicetre | Le Kremlin-Bicêtre , France, 94270CHRU Montpellier - Hopital Saint-Eloi | Montpellier , France, 34295 Cedex 5Clinique Ambroise Pare | Neuilly-sur-Seine , France, 92200CHU de Nice Hopital de l Archet | Nice , France, 06202Polyclinique Du Grand Sud | Nîmes , France, 30932CHU de Bordeaux - Hospital Haut-Leveque | Pessac , France, 33604Hospices Civils de Lyon HCL | Pierre-Bénite , France, 69495CHU de Reims | Reims , France, 51092Hopital d'Instruction des Armees BEGIN | Saint-Mandé , France, 94160CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez , France, 42270CHU Rangueil | Toulouse , France, 31059CHU Nancy Brabois | Vandœuvre-lès-Nancy , France, 54500Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau , Germany, 85221MVZ Sanaklinikum Duisburg | Duisburg , Germany, 47055Medizinische Hochschule Hannover | Hanover , Germany, 30625Praxisgemeinschaft Jerichow | Jerichow , Germany, 39319Staedtisches Klinikum Lueneburg | Lüneburg , Germany, 21339Magyar Honvedseg Egeszsegugyi Kozpont | Budapest , Hungary, 1062Semmelweis Egyetem | Budapest , Hungary, 1082Semmelweis Egyetem AOK | Budapest , Hungary, 1088Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont | Debrecen , Hungary, 4025Fortis Memorial Research Institute | Gurugram , India, 122002Asian Institute Of Gastroenterology | Hyderabad , India, 500032Kasturba Medical College Hospital | Manipal , India, 576104P D Hinduja National Hospital and Medical Research Center | Mumbai , India, 400016SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre | Surat , India, 395002Ha'Emek Medical Center | Afula , Israel, 1834111Bnai Zion Medical Center | Haifa , Israel, 3339419Wolfson Medical Center | Holon , Israel, 5822012Shaare Zedek Medical Center - Jerusalem, ISRAEL | Jerusalem , Israel, 91031Lev Talpiot Clinic | Jerusalem , Israel, 93624Galilee Medical Center | Nahariya , Israel, 2210001Chaim Sheba Medical Center | Ramat Gan , Israel, 5262000Tokyo Medical and Dental University Hospital | Bunkyō City , Japan, 113-8510Ginza central clinic | Chūōku , Japan, 1040061Sai Gastroenterology Proctology | Fujiidera-shi , Japan, 583-0027Fukuoka University Hospital | Fukuoka , Japan, 814 0180Fukushima Medical University Hospital | Fukushima , Japan, 960 1295Hachinohe City Hospital | Hachinohe , Japan, 031-8555Tokai University Hachioji Hospital | Hachiōji , Japan, 192-0032Matsuda Hospital | Hamamatsu , Japan, 432-8061National Hospital Organization Mito Medical Center | Higashiibaraki-gun , Japan, 311-3193Kagoshima University Hospital | Kagoshima , Japan, 890-8520Kagoshima IBD Gastroenterology Clinic | Kagoshima , Japan, 892-0843National Hospital Organization Kanazawa Medical Center | Kanazawa , Japan, 920-8650Tsujinaka Hospital Kashiwanoha | Kashiwa , Japan, 277-0871Kyushu Rosai Hospital | Kitakyushu , Japan, 800-0296Kumagaya General Hospital | Kumagaya-shi , Japan, 360-8567National Hospital Organization Kure Medical Center and Chugoku Cancer Center | Kure , Japan, 737-0023Tokushukai Chiba-Nishi General Hospital | Matsudo , Japan, 270-2251National Hospital Organization Matsumoto Medical Center | Matsumoto , Japan, 399-8701Yokoyama IBD Clinic | Nagoya , Japan, 460-0022Okayama Saiseikai General Hospital | Okayama , Japan, 700-0013Kinshukai Infusion Clinic | Osaka , Japan, 530-0011Japanese Red Cross Osaka Hospital | Osaka , Japan, 543 8555Oita Red Cross Hospital | Ōita , Japan, 870-0033Ishida Clinic of IBD and Gastroenterology | Ōita , Japan, 870-0823Kindai University Hospital | Ōsaka-sayama , Japan, 589-8511Dokkyo Medical University Hospital | Shimotsuga Gun , Japan, 321 0293Center Hospital of the National Center for Global Health and Medicine | Shinjuku Ku , Japan, 162 8655Tokyo Metropolitan Bokutoh Hospital | Sumida Ku , Japan, 130 8575National Hospital Organization Shizuoka Medical Center | Sunto-gun , Japan, 411-8611Juntendo University Hospital Urayasu | Urayasu , Japan, 279-0021Kanke Gastrointestinal Clinic | Utsunomiya , Japan, 320-0003Yokohama City University Medical Center | Yokohama , Japan, 232 0024The Speciality Hospital (TSH) / Advanced Clinical Center | Amman , Jordan, 11194Jordan University Hospital | Amman , Jordan, 11942Irbid Specialty Hospital | Aydoun , Jordan, 21166King Abdullah University Hospital | Irbid , Jordan, 22110Hospital Selayang | Batu Caves , Malaysia, 68100Hospital Pulau Pinang | George Town , Malaysia, 10990Hospital Sultanah Aminah | Johor Bahru , Malaysia, 80100University Malaya Medical Centre | Kuala Lumpur , Malaysia, 59100Hospital Umum Sarawak | Kuching , Malaysia, 93586Hospital Tuanku Jaafar | Seremban , Malaysia, 70300SCIENTIA Investigacion Clinica SC | Chihuahua City , Mexico, 31207Clinica de Investigacion en Reumatologia y Obesidad | Guadalajara , Mexico, 44650Clinicos Asociados BOCM, SC | Mexico City , Mexico, 03300Centro de Investigacion Clinica Acelerada S.C | Mexico City , Mexico, 07369Hospital Médica Sur Tlalpan | Mexico City , Mexico, 14050Medical Care & Research SA de CV | Mérida , Mexico, 97070Centro Regiomontano de Estudios Clínicos Roma S.C. | Monterrey , Mexico, 64610Fundacion Santos Y De La Garza Evia IBP | Monterrey , Mexico, 64710Clinical Research Institute Saltillo S.A. de C.V. | Saltillo , Mexico, 25020Oncare | San Pedro Garza García , Mexico, 66220Hutt Hospital | Boulcott , New Zealand, 5010Christchurch Hospital | Christchurch , New Zealand, 8011Dunedin Hospital | Dunedin , New Zealand, 9016Auckland City Hospital | Grafton , New Zealand, 1023Waikato Hospital | Hamilton , New Zealand, 3204Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok , Poland, 15-322Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz , Poland, 85-168Centrum Medyczne Lukamed Sp z o o 1 | Chojnice , Poland, 89 600Centrum Medyczne Lukamed Sp z o o | Chojnice , Poland, 89 600Centrum Medyczne Plejady | Krakow , Poland, 30 363Centrum Medyczne Promed | Krakow , Poland, 31-513Zespol Poradni Specjalistycznych REUMED Filia nr 2 | Lublin , Poland, 20-582EMC Instytut Medyczny SA PL CERTUS | Poznan , Poland, 60 309Centrum Medyczne Medyk | Rzeszów , Poland, 35-326Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin , Poland, 71-434GASTROMED Sp. z o.o. | Torun , Poland, 87 100Bodyclinic Sp. z o.o. sp. k | Warsaw , Poland, 03 712Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus | Warsaw , Poland, 04 501Przychodnia Vistamed | Wroclaw , Poland, 53 149Melita Medical Sp. z o.o. | Wroclaw , Poland, 53 611Pro Life Medica Sp z o o ETG Zamosc | Zamość , Poland, 22-400FNsP F.D.R. Banska Bystrica | Banská Bystrica , Slovakia, 975 17Cliniq s.r.o. | Bratislava , Slovakia, 811 09ENDOMED s.r.o | Košice , Slovakia, 040 13KM Management spol. s r.o. | Nitra , Slovakia, 949 01Inje University Haeundae Paik Hospital | Busan , South Korea, 48108Yeungnam University Hospital | Daegu , South Korea, 42415National Cancer Center | Goyang-si , South Korea, 10408Chosun university hospital | Gwangju , South Korea, 61453Korea University Ansan Hospital | Gyeonggi-do , South Korea, 15355Kangbuk Samsung Hospital | Seoul , South Korea, 03181Severance Hospital Yonsei University Health System | Seoul , South Korea, 03722Samsung Medical Center | Seoul , South Korea, 06351Chung-Ang University Hospital | Seoul , South Korea, 06973Kyung Hee University Hospital | Seoul , South Korea, 130 050The Catholic university of Korea, St. Vincent's Hospital | Suwon , South Korea, 16247Hosp. Univ. Germans Trias I Pujol | Badalona , Spain, 08916Hosp. Virgen Macarena | Seville , Spain, 41009Hosp. de La Marina Baixa | Villajoyosa , Spain, 03570Hosp. Univ. Miguel Servet | Zaragoza , Spain, 50009China Medical University Hospital | Taichung , Taiwan, 40447Taichung Veterans General Hospital | Taichung , Taiwan, 40705National Taiwan University Hospital | Taipei , Taiwan, 10002Mackay Memorial Hospital | Taipei , Taiwan, 10449Istanbul University | Istanbul , Turkey (Türkiye), 34098Ege University Medical Faculty | Izmir , Turkey (Türkiye), 35040Mersin University Medical Faculty | Mersin , Turkey (Türkiye), 33343
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  May 12, 2025Documents provided by Janssen Research & Development, LLC: Statistical Analysis Plan  April 21, 2024