Nipocalimab in Moderate to Severe Sjogren's Disease

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified June 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT06741969
Other Study ID Numbers:
80202135SJS3001
First Submitted
December 17, 2024
First Posted
December 18, 2024
Last Update Posted
July 5, 2026
Last Verified
June 2026

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

History of Changes

Study Details

Study Description

This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (\>=) 18 years of age with moderate to severe SjD.

Condition or DiseaseIntervention/Treatment
Sjogrens Syndrome
Drug: NipocalimabDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment655 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)
Study Start DateDecember 3, 2024
Actual Primary Completion Date1yr 5mos from now
Actual Study Completion Date2yrs 9mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Nipocalimab
Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Drug: Nipocalimab
Nipocalimab SC.
Placebo
Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
Drug: Placebo
Placebo SC.

Outcome Measures

Primary Outcome Measures
  1. Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
    ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.
Secondary Outcome Measures
  1. Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48
    The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.
  2. Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline
    ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
  3. Change from Baseline in ClinESSDAI Score at Week 8
    ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD.
  4. Change from Baseline in Stimulated Salivary Flow Rate at Week 48
    Stimulated salivary flow is considered a reliable and objective method to evaluate glandular function in SjD patients.
  5. Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48
    Participants will be asked to report the worst severity of their dryness symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms dryness score at Week 48 for US, US reference regions, and other non-US regions will be reported.
  6. Change from Baseline in Sjogren's Symptoms Joint Pain Score at Week 48
    Participants will be asked to report the worst severity of their joint pain symptoms on a 0 to 10 numeric rating scale (NRS), with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". Higher scores reflect greater symptom severity. Change from baseline in Sjogren's Symptoms joint pain score at Week 48 for US, US reference regions, and other non-US regions will be reported.
  7. Change from Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Score At Week 48
    ESSPRI is a participant-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue, and pain on a 0 to 10 NRS, with score 0 indicating "No \[specific symptom\]" and score 10 indicating "Severe \[specific symptom\]". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity. Change from baseline in Sjogren's Symptoms score at Week 48 for EU, UK \& EU reference regions will be reported.
  8. Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 48
    FACIT-Fatigue version 4.0 is a 13-item questionnaire that assesses participant-reported fatigue and its impact upon daily activities and function over the past 7 days. Participants will be asked to answer each question using a 5-point Likert scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much). FACIT-Fatigue has a total score range from 0 to 52, with 0 being the worst possible score and 52 the best.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
-
Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
Total ClinESSDAI score greater than or equal to (\>=) 5 at screening
Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization
Exclusion Criteria
Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example \[e.g.\], monoclonal antibodies, intravenous immunoglobulin)
Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
Advanced Clinical Research Center | Chula Vista California, United States, 91910Providence Medical Foundation | Fullerton California, United States, 92835Arthritis & Osteoporosis Medical Center - La Palma | La Palma California, United States, 90623NovaMed Research | Monterey Park California, United States, 91754Medvin Clinical Research San Leandro | San Leandro California, United States, 94578Providence Saint John s Health Center | Santa Monica California, United States, 90404Solace Clinical Research California | Tustin California, United States, 92780Inland Rheumatology Clinical Trials Inc. | Upland California, United States, 91786Denver Arthritis Clinic | Denver Colorado, United States, 80230Clinical Research of West Florida Inc | Clearwater Florida, United States, 33765UF Health Rheumatology | Jacksonville Florida, United States, 32256Suncoast Clinical Research | New Port Richey Florida, United States, 34652Sarasota Arthritis Center | Sarasota Florida, United States, 34239BioResearch Partner | South Miami Florida, United States, 33143Immunology and Rheumatology Research Associates LLC | Suwanee Georgia, United States, 30024Clinical Investigation Specialists - Clinic of Robert Hozman | Skokie Illinois, United States, 60076Willow Rheumatology and Wellness PLLC | Willowbrook Illinois, United States, 60527University of Iowa Hospital and Clinics | Iowa City Iowa, United States, 52242University of Kansas Medical Center | Kansas City Kansas, United States, 66160Clinical Research Institute of Michigan, LLC | Saint Clair Shores Michigan, United States, 48081St. Paul Rheumatology P A | Eagan Minnesota, United States, 55123AARA Clinical Research- Kansas City Physicians Partners | Kansas City Missouri, United States, 64151Arthritis Rheumatic And Back Disease Associates | Voorhees Township New Jersey, United States, 08043NYU Langone Health - Clinical and Translational Science Institute | New York New York, United States, 10016Pioneer Clinical Research NY | New York New York, United States, 10016Joint and Muscle Research Institute | Charlotte North Carolina, United States, 28204Atrium Health SouthPark Rheumatology | Charlotte North Carolina, United States, 28211Onsite Clinical Solutions | Salisbury North Carolina, United States, 28144Wright State Physicians Health Center | Fairborn Ohio, United States, 45324OMRF Rheumatology Center of Excellence | Oklahoma City Oklahoma, United States, 73104Rheumatology Associates of Oklahoma | Oklahoma City Oklahoma, United States, 73116Altoona Center For Clinical Research | Duncansville Pennsylvania, United States, 16635Clinical Research Philadelphia | Philadelphia Pennsylvania, United States, 19114Low Country Rheumatology PA | Summerville South Carolina, United States, 29486West Tennessee Research Institute | Jackson Tennessee, United States, 38305AARA Clinical Research - Murfreesboro Medical Clinic | Murfreesboro Tennessee, United States, 37128Amarillo Premier Research | Amarillo Texas, United States, 79124Texas Rheumatology Research Institute LLC | Plano Texas, United States, 75024Fort Bend Rheumatology Associates PLLC | Sugar Land Texas, United States, 77479Advanced Rheumatology of Houston | The Woodlands Texas, United States, 77382Alpine Research TC LLC | Layton Utah, United States, 84041Tidewater Clinical Research | Chesapeake Virginia, United States, 23320Overlake Arthritis and Osteoporosis Center | Bellevue Washington, United States, 98004Instituto Medico De Alta Complejidad (IMAC) | Buenos Aires , Argentina, B1643CROCentro de Investigacion San Miguel CISM | Buenos Aires , Argentina, B1663GJEMautalen Salud e Investigacion | CABA , Argentina, C1128AAFCentro Medico del Dr. Javier Gerardo Tartaglione | Cdad Autonoma de Buenos Aires , Argentina, C1123AAOCentro de Investigacion en Enfermedades Reumaticas CIER | Ciudad de Buenos Aires , Argentina, C1055Centro Medico Barrio Parque. Swiss Medical Group | Ciudad de Buenos Aires , Argentina, C1414Cosultorios Reumatologógicos Pampa | Ciudad de Buenos Aires , Argentina, C1428Cer Instituto Medico | Quilmes , Argentina, B1878DVBMR Medicina Reumatologica | San Fernando , Argentina, B1646GHPCentro de Investigaciones Medicas Tucuman | San Miguel de Tucumán , Argentina, T4000AXLMedizinische Universitaet Graz | Graz , Austria, 8036SCRI CCCIT gem GmbH | Salzburg , Austria, 5020LK Weinviertel Stockerau | Stockerau , Austria, 2000Medizinische Universitaet Wien | Vienna , Austria, 1090Wiener Gesundheitsverbund Klinik Hietzing | Vienna , Austria, 1130Instituto D Or de Pesquisa e Ensino 1 | Brasília , Brazil, 70390 700Ceti - Centro de Estudos Em Terapias Inovadoras | Curitiba , Brazil, 80030 110Hospital das Clinicas de Porto Alegre | Porto Alegre , Brazil, 90035-903LMK Servicos Medicos S S | Porto Alegre , Brazil, 90480 000Associacao Hospitalar Moinhos de Vento | Porto Alegre , Brazil, 90560032Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto | Ribeirão Preto , Brazil, 14048 900SER - Servicos Especializados em Reumatologia da Bahia | Salvador , Brazil, 40150 150Instituto D Or de Pesquisa e Ensino | Salvador , Brazil, 41253 190Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base | São José do Rio Preto , Brazil, 15090 000EBSERH Empresa de Servicos Hospitalares Hospital Samaritano | São Paulo , Brazil, 01229 001CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos | São Paulo , Brazil, 04266 010Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo , Brazil, 05403 000CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda | Vitória , Brazil, 29055 450UMHAT Kaspela | Plovdiv , Bulgaria, 4001Medical Center Artmed | Plovdiv , Bulgaria, 4002Medical Center Teodora | Rousse , Bulgaria, 7003Lyulin Multi Profile Hospital For Active Medical Treatment | Sofia , Bulgaria, 1336Diagnostic-Consultative Center (DCC) Aleksandrovska | Sofia , Bulgaria, 1431St Ivan Rilski University Multiprofile Hospital For Active Treatment | Sofia , Bulgaria, 1431Military Medical Academy Multiprofile Hospital for Active Treatment Sofia | Sofia , Bulgaria, 1606Diagnostic Consultative Center - DCC Equita EOOD | Varna , Bulgaria, 9000MHAT 'St. Marina' EAD | Varna , Bulgaria, 9010Dr Sabeen Anwar Medicine Professional Corporation | Windsor Ontario, Canada, N8X 1T3Hospital Regional de Rimouski | Rimouski Quebec, Canada, G5L 5T1Centre de Recherche Musculo Squelettique | Trois-Rivières Quebec, Canada, G9A 3X2Beiijing Friendship Hospital, Capital Medical University | Beijing , China, 100050Peking University Third Hospital | Beijing , China, 100191Xiangya Hospital Central South University | Changsha , China, 410008Changzhou No 2 Peoples Hospital | Changzhou , China, 213164West China Hospital Sichuan University | Chengdu , China, 610041Dazhou Central Hospital | Dazhou , China, 635002First Affiliated Hospital of Gannan Medical University | Ganzhou , China, 341006Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou , China, 510275The Affiliated Hospital of Guizhou Medical University | Guiyang , China, 550004The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou , China, 311608Anhui Provincial Hospital | Hefei , China, 230001Shandong Provincial Hospital | Jinan , China, 250021Jinhua municipal central hospital | Jinhua , China, 321013Linyi City People Hospital | Linyi , China, 276002The First Affiliated Hospital of NanChang University | Nanchang , China, 330019Affiliated Hospital of North Sichuan Medical College | Nanchong , China, 637503Zhongda Hospital Southeast University | Nanjing , China, 210009The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning , China, 530000Ningbo medical center lihuili hospital | Ningbo , China, 315041Huashan Hospital affiliated to Fudan University | Shanghai , China, 200031Shenshan Medical Center Memorial Hospital of Sun Yat Sen University | Shanwei , China, 516601The Second Hospital of Hebei Medical University | Shijiazhuang , China, 050004Shanxi Academy of Medical Sciences | Taiyuan , China, 030000Tianjin First Central Hospital | Tianjin , China, 300384The First Affiliated Hospital of Wenzhou Medical University | Wenzhou , China, 325000The first affiliated hospital of xiamen university | Xiamen , China, 361003Xinxiang Central Hospital | Xinxiang , China, 453099The Affiliated Hospital of Xuzhou Medical University | Xuzhou , China, 221000People s Hospital of Ningxia Hui Autonomous Region | Yinchuan , China, 750031Zhongshan Traditional Chinese Medicine Hospital | Zhongshan , China, 528401Revmatologie s r o | Brno , Czechia, 63800Revimex Pro s r o | Karvina Frystat , Czechia, 73301Artroscan s r o | Ostrava , Czechia, 722 00Nuselska Poliklinika | Prague , Czechia, 140 00MEDICAL PLUS Research, s.r.o. | Uherské Hradiště , Czechia, 68601Aarhus University Hospital | Aarhus , Denmark, 8200Rigshospitalet | Copenhagen , Denmark, 2100Zealand University Hospital | Køge , Denmark, 4600CHU de Brest - Hopital de la Cavale Blanche | Brest , France, 29200CHU Dijon Bourgogne - Hopital Francois Mitterrand | Dijon , France, 21000Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud | Le Kremlin-Bicêtre , France, 94270CHRU de Lille Hopital Claude Huriez | Lille , France, 59037CHRU Montpellier Hopital Lapeyronie | Montpellier , France, 34090CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez , France, 42270CHRU de Strasbourg - Hopital de Hautepierre | Strasbourg , France, 67200CHU Bordeaux | Talence , France, 33400Krankenhaus Porz am Rhein | Cologne , Germany, 51149Universitatsklinikum Carl Gustav Carus Dresden | Dresden , Germany, 01307Universitatsklinikum Erlangen Medizinische Klinik 3 | Erlangen , Germany, 91054Universitatsklinikum Freiburg | Freiburg im Breisgau , Germany, 79106Hamburger Rheuma Forschungszentrum II | Hamburg , Germany, 20095Medizinische Hochschule Hannover | Hanover , Germany, 30625Rheumazentrum Ruhrgebiet | Herne , Germany, 44649Klinikum der Universitaet Muenchen | München , Germany, 80336Medicover Muenchen Ost MVZ | München , Germany, 81667Rheumazentrum Ratingen | Ratingen , Germany, 40878Universitaetsklinikum Wuerzburg | Würzburg , Germany, 97080Queen Mary Hospital | Hong Kong , Hong Kong, Tuen Mun Hospital | Hong Kong , Hong Kong, Semmelweis Egyetem Reumatologiai es Immunologiai Klinika | Budapest , Hungary, 1023Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz | Budapest , Hungary, 1027Clinexpert Kft | Budapest , Hungary, 1033Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely | Budapest , Hungary, 1097Debreceni Egyetem Klinikai Kozpont | Debrecen , Hungary, 4032Szegedi Tudomanyegyetem | Szeged , Hungary, 6725Vita Verum Medical Egeszsegugyi Szolgaltato Bt | Székesfehérvár , Hungary, 8000Barzilai Medical Center | Ashkelon , Israel, 7830604Rambam Health Care Campus | Haifa , Israel, 3109601Carmel Medical Center | Haifa , Israel, 34362Tzafon Medical Center Poria | Har Poriyya , Israel, 1528001Galil Medical Center | Nahariya , Israel, 2210001Rabin Medical Center | Petah Tikva , Israel, 4941492Sheba Medical Center | Ramat Gan , Israel, 5262100Sourasky Medical Center | Tel Aviv , Israel, Ospedale San Raffaele | Milan , Italy, 20132Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO | Milan , Italy, 20122Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Palermo , Italy, 90127Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia | Perugia , Italy, 06129Azienda Ospedaliero Universitaria Pisana | Pisa , Italy, 56126Umberto I Policlinico di Roma | Roma , Italy, 00161Fondazione Policlinico Universitario A Gemelli IRCCS | Roma , Italy, 00168Campus Bio Medico di Roma | Roma , Italy, 128Istituto Clinico Humanitas | Rozzano , Italy, 20089Ospedale S. Maria Della Misericordia | Udine , Italy, 33100St. Luke's International Hospital | Chūōku , Japan, 104 8560Tokyo Metropolitan Tama Medical Center | Fuchū , Japan, 183 8524National Hospital Organization Kyushu Medical Center | Fukuoka , Japan, 810 8563National Hospital Organization Osaka Minami Medical Center | Kawachi-Nagano , Japan, 586 8521Shinkenko Clinic | Naha , Japan, 900 0015Okayama City General Medical Center Okayama City Hospital | Okayama , Japan, 700 8557Hokkaido University Hospital | Sapporo , Japan, 060 8648Sasebo Chuo Hospital | Sasebo , Japan, 857 1195Tohoku Medical And Pharmaceutical University Hospital | Sendai , Japan, 983 0005Dokkyo Medical University Hospital | Shimotsuga Gun , Japan, 321 0293Tokyo Metropolitan Bokutoh Hospital | Sumida Ku , Japan, 130 8575Nihon University Itabashi Hospital | Tokyo , Japan, 173 8610Centro de Investigacion de Tratamientos Innovadores de Sinaloa | Culiacán , Mexico, 80000Clinica de Investigacion en Reumatologia y Obesidad | Guadalajara , Mexico, 44650Centro Medico Nacional Siglo XXI IMSS | Mexico City , Mexico, 06720Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico D F , Mexico, 14080Medical Care & Research SA de CV | Mérida , Mexico, 97070CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V | México , Mexico, 06700SMIQ S de R L de C V | Querétaro , Mexico, 76070Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi | San Luis Potosí City , Mexico, 78213Medisch Spectrum Twente | Enschede , Netherlands, 7512 KZOslo universitetssykehus HF, Rikshospitalet | Oslo , Norway, 0372Stavanger University Hospital | Stavanger , Norway, 4011MICS Centrum Medyczne Bydgoszcz | Bydgoszcz , Poland, 85 065Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz , Poland, 85 168ETG Debica | Dębica , Poland, 39 200Malopolskie Badania Kliniczne Sp z o o | Krakow , Poland, 30-002Futuremeds Krakow | Krakow , Poland, 31 501ETG Lublin Poradnie Specjalistyczne | Lublin , Poland, 20 412Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A | Olsztyn , Poland, 10 117AI Centrum Medyczne | Poznan , Poland, 61 113ETG Siedlce | Siedlce , Poland, 08 110MICS Centrum Medyczne Warszawa | Warsaw , Poland, 00 874Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher | Warsaw , Poland, 02 637FutureMeds Targowek | Warsaw , Poland, 03 291Centrum Medyczne Oporow | Wroclaw , Poland, 52 416FutureMeds Wroclaw | Wroclaw , Poland, 53 673Ipr Inst Port de Reumatologia | Lisbon , Portugal, 1050 034Uls Lisboa Ocidental - Hosp. Egas Moniz | Lisbon , Portugal, 1349 019Uls Santa Maria - Hosp. Santa Maria | Lisbon , Portugal, 1649 035Uls Gaia Espinho | Vila Nova de Gaia , Portugal, 4434 502Spitalul Clinic Sf Maria | Bucharest , Romania, 011172Spitalul Clinic Colentina | Bucharest , Romania, 020125Policlinica CCBR SRL | Bucharest , Romania, 030463Hiperdia SA | Bucharest , Romania, 041312Spitalul Clinic Judetean de Urgenta Cluj | Cluj-Napoca , Romania, 400006Medisof Diagnostic S R L | Craiova , Romania, 200347Selfmed Clinique S.R.L. | Timișoara , Romania, 300133Chonnam National University Hospital | Gwangju , South Korea, 61469Seoul National University Bundang Hospital | Seongnam-si , South Korea, 13620Seoul National University Hospital | Seoul , South Korea, 03080Hanyang University Medical Center | Seoul , South Korea, 04763Konkuk University Medical Center | Seoul , South Korea, 05030The Catholic University of Korea Seoul St Mary s Hospital | Seoul , South Korea, 06591The Catholic university of Korea, St. Vincent's Hospital | Suwon , South Korea, 16247Ajou University Hospital | Suwon , South Korea, 16499Hosp. Cima Sanitas Barcelona | Barcelona , Spain, 08034Hosp Univ Vall D Hebron | Barcelona , Spain, 08035Hosp. de La Santa Creu I Sant Pau | Barcelona , Spain, 08041Hosp. Gral. Juan Ramon Jimenez | Huelva , Spain, 21005Hosp. Univ. 12 de Octubre | Madrid , Spain, 28041Hosp. de Navarra | Pamplona , Spain, 310008Hosp. Univ. Marques de Valdecilla | Santander , Spain, 39008Hosp. Infanta Luisa | Seville , Spain, 41010Universitatsspital Basel | Basel , Switzerland, 4031Kantonsspital St Gallen | Sankt Gallen , Switzerland, 9000NTU Biomedical Park Hospital | Hsinchu , Taiwan, 302058Kaohsiung Veterans General Hospital | Kaohsiung City , Taiwan, 81362Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City , Taiwan, 833Taipei Medical University Shuang Ho Hospital | New Taipei City , Taiwan, 23561China Medical University Hospital | Taichung , Taiwan, 404332Taipei Veterans General Hospital | Taipei , Taiwan, 11217Linkou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 333Gulhane Training and Research Hospital | Ankara , Turkey (Türkiye), 06010Gazi University Medical Faculty | Ankara , Turkey (Türkiye), 06560Ankara Bilkent City Hospital | Ankara , Turkey (Türkiye), 06800Uludag University Medical Faculty | Bursa , Turkey (Türkiye), 16059Marmara University Istanbul Pendik Education and Research Hospital | Istanbul , Turkey (Türkiye), 34899Necmettin Erbakan University | Konya , Turkey (Türkiye), 42090Cambridge University Hospitals NHS Foundation Trust | Cambridge , United Kingdom, CB2 0QQDoncaster Royal Infirmary | Doncaster , United Kingdom, DN2 5LTBarts Health NHS Trust | Greater London , United Kingdom, E1 4DGLeeds Teaching Hospitals NHS Trust | Leeds , United Kingdom, LS7 4SAUniversity Hospital Aintree | Liverpool , United Kingdom, L9 7ALWest Middlesex University Hospital | London , United Kingdom, TW7 6AFPeterborough City Hospital | Peterborough , United Kingdom, PE3 9GZGreat Western Hospital | Swindon , United Kingdom, SN3 6BB
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC