A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified November 2025 by Amgen
Sponsor
Amgen
Information Provided by (Responsible Party)
Amgen
Clinicaltrials.gov Identifier
NCT06245408
Other Study ID Numbers:
HZNP-DAZ-303
First Submitted
January 29, 2024
First Posted
February 6, 2024
Last Update Posted
January 7, 2026
Last Verified
November 2025

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

History of Changes

Study Details

Study Description

Acquired from Horizon in 2024.

Condition or DiseaseIntervention/Treatment
Sjögren's Syndrome (SS)
Drug: DazodalibepDrug: DazodalibepDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment434 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-Severe Symptom State (HZNP-DAZ-303)
Study Start DateApril 7, 2024
Actual Primary Completion Date2mos 4w from now
Actual Study Completion Date4mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Dazodalibep Dose 1
Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
Drug: Dazodalibep
IV infusion
Dazodalibep Dose 2
Participants will be administered dose 2 of dazodalibep by IV infusion.
Drug: Dazodalibep
IV infusion
Placebo
Participants will be administered placebo by IV infusion.
Drug: Placebo
IV infusion

Outcome Measures

Primary Outcome Measures
  1. Change from baseline in ESSPRI score
  2. Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score
Secondary Outcome Measures
  1. Proportion of participants achieving meaningful improvement in DASPRI
  2. Proportion of participants achieving ESSPRI [1.5] response
  3. Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a)
  4. Change from baseline in DASPRI Dryness
  5. Change from baseline in ESSPRI Dryness
  6. Change from baseline in DASPRI Pain
  7. Change from baseline in ESSPRI Pain
  8. Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score
  9. Change from baseline in DASPRI total score
  10. Change from baseline in ESSPRI total score
  11. Change from baseline in DASPRI Fatigue
  12. Change from baseline in ESSPRI fatigue domain score
  13. Change from baseline in total stimulated salivary flow
  14. Number of participants With Treatment Emergent Adverse Events (TEAEs)
  15. Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
  16. Number of participants With Adverse Events of Special Interest (AESIs)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria 2. Have an ESSPRI score of ≥ 5 at screening. 3. Have an ESSDAI score of \< 5 at screening. 4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test). 5. Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min. 6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination. 7. Meets all of the following tuberculosis (TB) criteria: 1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment. 2. No signs or symptoms suggestive of active TB from medical history or physical examination. 3. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor). 4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded. 5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS). Key
Exclusion Criteria
1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening. 2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis. 3. Active malignancy or history of malignancy within the last 5 years, except as follows: 1. In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR 2. Cutaneous basal cell carcinoma following presumed curative therapy. 4. Individuals who are pregnant or lactating or planning to become pregnant during the study. 5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy. 6. Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results. 7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection. 8. Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization. 9. Individuals with: 1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. 2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening.

Contacts and Locations

Sponsors and CollaboratorsAmgen
Locations
Arizona Arthritis & Rheumatology Associates - Avondale | Avondale Arizona, United States, 85392Arizona Research Clinic PLLC | Chandler Arizona, United States, 85225-2915Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln | Flagstaff Arizona, United States, 86001-6299Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St | Gilbert Arizona, United States, 85297-7338Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln | Glendale Arizona, United States, 85306-9800Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd | Tucson Arizona, United States, 85704-1140Medvin Clinical Research - Covina | Covina California, United States, 91723UCSD Altman Clinical and Translational Research Institute Building | La Jolla California, United States, 92037-1337Inland Rheumatology Clinical Trials Incorporated | Upland California, United States, 91786-4951Medvin Clinical Research | Whittier California, United States, 90602Tekton Research, LLC - 2121 E Harmony Rd - PPDS | Fort Collins Colorado, United States, 80528-3400Bradenton Research Center Inc | Bradenton Florida, United States, 34205-1704Clinical Research of West Florida Inc - Clearwater | Clearwater Florida, United States, 33765-2616West Broward Rheumatology Associates, Inc. | Tamarac Florida, United States, 33321-2956BayCare Medical Group Primary Care and Rheumatology - Tampa | Tampa Florida, United States, 33614-7101University of Kansas Medical Center | Kansas City Kansas, United States, 66160-8500Tufts Medical Center - Rheumatology Research Office - PPDS | Boston Massachusetts, United States, 02111-1552Clinical Research Institute of Michigan, LLC-St. Claire Shores | Saint Clair Shores Michigan, United States, 48081Kansas City Physician Partners-8350 N Saint Clair Ave | Kansas City Missouri, United States, 64151-5100Arthritis, Rheumatic & Bone Disease Associates - P | Voorhees Township New Jersey, United States, 08043-4509Albuquerque Center for Rheumatology | Albuquerque New Mexico, United States, 87102-1710NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center | Brooklyn New York, United States, 11201-5501Arthritis and Osteoporosis Consultants of The Carolinas | Charlotte North Carolina, United States, 28207-1100Duke Early Phase Clinical Research Unit - PPDS | Durham North Carolina, United States, 27710-0001Onsite Clinical Solutions, LLC - Salisbury | Salisbury North Carolina, United States, 28144Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg | Miamisburg Ohio, United States, 45342-3585University of Toledo Medical Center | Toledo Ohio, United States, 43614-2595STAT Research-600 Aviator Ct | Vandalia Ohio, United States, 45377-9474Low Country Rheumatology PA-Summerville | Summerville South Carolina, United States, 29486Murfreesboro Medical Clinic Westlawn | Murfreesboro Tennessee, United States, 37128Amarillo Center For Clinical Research | Amarillo Texas, United States, 79124-1601Accurate Clinical Management-Baytown | Baytown Texas, United States, 77521Precision Comprehensive Clinical Research Solutions | Grapevine Texas, United States, 76051-3143R & H Clinical Research-777 S Fry Rd | Katy Texas, United States, 77450-2297Texas Arthritis & Rheumatology Associates | Katy Texas, United States, 77450Valley Arthritis Center | McAllen Texas, United States, 78501University of Texas - San Antonio - Health Science Center - PPDS | San Antonio Texas, United States, 78229-3901Advanced Rheumatology of Houston - The Woodlands | The Woodlands Texas, United States, 77382DM Clinical Research - Migraine and COPD - PPDS | Tomball Texas, United States, 77375Western Washington Medical Group | Bothell Washington, United States, 98021-4418Rheumatology and Pulmonary Clinic | Beckley West Virginia, United States, 25801-2805Sanatorio Agote - Swiss Medical Group - PPDS | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1425EOESanatorio Guemes | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1425EUGFramingham Centro Médico | La Plata Buenos Aires, Argentina, B1900Instituto CER S.A. | Quilmes Buenos Aires, Argentina, B1878DVBInstituto de Investigaciones Clinicas Quilmes SRL | Quilmes Buenos Aires, Argentina, B1878GEGHospital General de Agudos Dr. José María Ramos Mejia | Buenos Aires Ciudad Autónoma de BuenosAires, Argentina, C1121ADCConsultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS | Buenos Aires Ciudad Autónoma de BuenosAires, Argentina, C1426Centro de Investigaciones Médicas Tucumán - PPDS | San Miguel de Tucumán Tucumán Province, Argentina, T4000AXLCentro de Investigaciones Reumatológicas | San Miguel de Tucumán Tucumán Province, Argentina, T4000AXLClínica Mayo de U.M.C.B. S.R.L | San Miguel de Tucumán Tucumán Province, Argentina, T4000IHEDOM Centro de Reumatología | Buenos Aires , Argentina, C1111AAHAprillus Asistencia e Investigacion de Arcis Salud SRL | Buenos Aires , Argentina, C1406AGACentro Medico Arsema | Buenos Aires , Argentina, C1427CCLSanatorio Allende S.A | Córdoba , Argentina, X5000JHQCentro Polivalente de Asistencia e Investigación Clínica - CER San Juan | San Juan , Argentina, J5400DILThe Queen Elizabeth Hospital | Woodville South South Australia, Australia, 5011UZ Gent | Ghent , Belgium, 9000SER - Serviços Especializados em Reumatologia da Bahia S/S - ME | Salvador Estado de Bahia, Brazil, 40150-150Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS | Belo Horizonte Minas Gerais, Brazil, 30150-221Centro de Estudos em Terapias Inovadoras | Curitiba Paraná, Brazil, 80030-110LMK Servicos Medicos SS | Porto Alegre Rio Grande do Sul, Brazil, 90480-000Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille | Trois-Rivières Quebec, Canada, G9A 3X2Clinical Research Chile SpA - PPDS | Valdivia Los Ríos Region, Chile, 5090000BIOCINETIC Ltda | Peñalolén Región-MetropolitanadeSantiago, Chile, 7910000Enroll SpA - Dr. Manuel Barros Borgono - PPDS | Santiago Región-MetropolitanadeSantiago, Chile, Centro de Investigacion de Enfermedades Respiratorias e inmunologicas | Viña del Mar Valparaiso, Chile, 2520000Clinical Center Zagreb - Oncology - Salata 7 - PPDS | Zagreb City of Zagreb, Croatia, 10000Clinical Hospital Sveti Duh | Zagreb City of Zagreb, Croatia, 10000Polyclinic Bonifarm | Zagreb City of Zagreb, Croatia, 10000Clinical Hospital Centre Osijek | Osijek , Croatia, 31000University Hospital of Split-Spinciceva 1 | Split , Croatia, 21000CHU de Bordeaux - Hôpital Saint-André | Bordeaux , France, 33000CHU de Brest - Hôpital La Cavale Blanche | Brest , France, 29609Hopital Emile Muller | Mulhouse , France, 68100AP-HP - Hôpital Saint Antoine | Paris , France, 75571Hôpitaux Universitaires de Strasbourg | Strasbourg , France, 67200University Clinic Heidelberg | Heidelberg Baden-Wurttemberg, Germany, 69120Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan | Bad Doberan Mecklenburg-Vorpommern, Germany, 18209Rheumazentrum Greifswald | Greifswald Hansestadt Mecklenburg-Vorpommern, Germany, 17493DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein | Chemnitz , Germany, 09117MVZ Rheuma | Hamburg , Germany, 20095Laiko General Hospital of Athens | Athens Attica, Greece, 115 27University General Hospital of Larissa | Larissa Larisa, Greece, 411 10Euromedica Kianous Stavros | Thessaloniki , Greece, 546 36Bekes Varmegyei Kozponti Korhaz | Gyula Bekes County, Hungary, 5700Vasarhelyi Sarkanyfu Kft. | Hódmezővásárhely Csongrád megye, Hungary, 6800Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7 | Budapest , Hungary, 1097AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova | Reggio Emilia Emilia-Romagna, Italy, 42121Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia | Udine Friuli Venezia Giulia, Italy, 33100Fondazione Policlinico Universitario Campus Bio-Medico | Rome Lazio, Italy, 00128Fondazione Policlinico Universitario A Gemelli - Rome - PPDS | Rome Lazio, Italy, 00168Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan Lombardy, Italy, 20122Azienda Ospedaliero Universitaria Maggiore della Carità | Novara Piedmont, Italy, 28100Azienda Ospedaliera Universitaria Careggi | Florence Tuscany, Italy, 50134Azienda Ospedaliera Universitaria Integrata Di Verona | Verona Veneto, Italy, 37134AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco | Catania , Italy, 95121Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara | Pisa , Italy, 56126Chubu Rosai Hospital | Nagoya Aiti, Japan, 455-0018Japan Community Health Care Organization (JCHO) Chukyo Hospital | Nagoya Aiti, Japan, 457-0866Daido Clinic | Nagoya Aiti, Japan, 457-8511Sapporo Medical University Hospital | Sapporo Hokkaidô, Japan, 060-8543Hokkaido University Hospital | Sapporo Hokkaidô, Japan, 060-8648Hospital of the University of Occupational and Environmental Health, Japan | Kita Kyushu-shi Hukuoka, Japan, 807-8556Hyogo Medical University Hospital | Nishinomiya-Shi Hyôgo, Japan, 663-8501University of Tsukuba Hospital | Tsukuba Ibaraki, Japan, 305-8576Kanazawa Medical University Hospital | Kahoku Ishikawa-ken, Japan, 920-0293Kanazawa University Hospital | Kanazawa Ishikawa-ken, Japan, 920-8641National Hospital Organization Yokohama Medical Center | Yokohama Kanagawa, Japan, 245-8575University Hospital, Kyoto Prefectural University of Medicine | Kyoto Kyôto, Japan, 602-8566Kyoto University Hospital | Kyoto Kyôto, Japan, 606-8507Nagasaki University Hospital | Nagasaki Nagasaki, Japan, 852-8501Sasebo Chuo Hospital | Sasebo-Shi Nagasaki, Japan, 857-1165Kurashiki Medical Clinic | Kurashiki-Shi Okayama-ken, Japan, 710-0824Saitama Medical University Hospital | Iruma-gun Saitama, Japan, 350-0495Hamamatsu University Hospital | Hamamatsu Shizuoka, Japan, 431-3192St. Luke's International Hospital | Chuo-Ku Tokyo, Japan, 104-0044Tokyo Medical Center | Meguro-Ku Tokyo, Japan, 152-8902Keio University Hospital | Shinjuku-Ku Tokyo, Japan, 160-8582Nihon University Itabashi Hospital | tabashi City Tokyo, Japan, 173-8610Mediadvance Clinical S.A.P.I. de C.V. | Parques de San Felipe Chihuahua, Mexico, 31203CIMAB SA de CV | Torreón Centro Coahuila, Mexico, 27000Centro de Investigación en Artritis y Osteoporosis - PPDS | Mexicali Estado de Baja California, Mexico, 21200Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS | Americana Jalisco, Mexico, 44160Cryptex Investigación Clínica, S.A. de C.V. | Mexico City Mexico City, Mexico, 6100Centro de Investigación y Tratamiento Reumatológico S.C | San Miguel Chapultepec Mexico City, Mexico, 11850Oaxaca Site Management Organization - Clinic - OSMO - PPDS | Centro Oaxaca, Mexico, 68000Consultorio de Reumatologia | México , Mexico, 07760Clinstile, S.A. de C.V. | México , Mexico, Hospital Universitario Dr. Jose Eleuterio González | Mitras Centro , Mexico, 64460Accelerium, S. de R.L. de C.V. - PPDS | Monterrey , Mexico, 64000Optimal Clinical Trials Ltd - PPDS | Auckland North Island, New Zealand, 1003Aotearoa Clinical Trials Trust | Auckland , New Zealand, 2025Waikato Hospital | Hamilton , New Zealand, 3214Clinica San Antonio S.A.C | Trujillo La Libertad, Peru, 13008Clinica San Juan Bautista | San Juan de Lurigancho Lima region, Peru, 15431Hogar Clinica San Juan de Dios - Arequipa | Arequipa , Peru, 04013Hospital Militar Central Luis Arias Schereiber | Lima , Peru, 11Clínica Internacional San Borja-Avenida Guardia Civil 385 | Lima , Peru, 15001Instituto Peruano del Hueso y la Articulacion S.A.C. | Lima , Peru, 15046Instituto de Ginecologia y Reproduccion - PPDS | Lima , Peru, Lima 33Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada | Pueblo Libre , Peru, Lima 21Malopolskie Centrum Kliniczne | Krakow Lesser Poland Voivodeship, Poland, 30-149FutureMeds - Wroclaw - PPDS | Wroclaw Lower Silesian Voivodeship, Poland, 50-088Centrum Medyczne Oporow | Wroclaw Lower Silesian Voivodeship, Poland, 52-416ETG Lublin - PPDS | Lublin Lublin Voivodeship, Poland, 20-412Reumed Sp. z o.o. | Lublin Lublin Voivodeship, Poland, 20-607FutureMeds - Warszawa Centrum - PPDS | Warsaw Masovian Voivodeship, Poland, 00-215MICS Centrum Medyczne Warszawa - MICS - PPDS | Warsaw Masovian Voivodeship, Poland, 00-874MTZ Clinical Research Powered by PRATIA - PPDS | Warsaw Masovian Voivodeship, Poland, 02-172Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher | Warsaw Masovian Voivodeship, Poland, 02-637Klinika Reuma Park sp . zoo Sp.k. | Warsaw Masovian Voivodeship, Poland, 02-665K2J2 Medical Center | Wołomin Masovian Voivodeship, Poland, 05-200Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o. | Malbork Pomeranian Voivodeship, Poland, 82-200Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy | Bydgoszcz , Poland, 85-168Centrum Medyczne Pratia Katowice - PPDS | Katowice , Poland, 40-081Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa | Krakow , Poland, 30-363FutureMeds - Lodz - PPDS | Lodz , Poland, 91-363Twoja Przychodnia PCM | Poznan , Poland, 60-324WIM-PIB, Centralny Szpital Kliniczny MON | Warsaw , Poland, 04-141Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213 | Wroclaw , Poland, 50-556Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3 | Wroclaw , Poland, 53-034ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz | Lisbon , Portugal, 1300-344Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS | Lisbon , Portugal, 1649-035Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima | Ponte de Lima , Portugal, 4990-041ULS de Gaia/Espinho, EPE - Unidade I | Vila Nova de Gaia , Portugal, 4434-502GCM Medical Group, PSC -62 Calle Jose Marti | San Juan , Puerto Rico, 00917Institute of Rheumatology - PPDS | Belgrade , Serbia, 11000Military Medical Academy | Belgrade , Serbia, 11000University Clinical Center of Serbia - Pasterova 2 - PPDS | Belgrade , Serbia, 11000University Clinical Center Kragujevac | Kragujevac , Serbia, 34000Clinical Centre of Vojvodina | Novi Sad , Serbia, 21000Special Hospital For Rheumatic Diseases Novi Sad | Novi Sad , Serbia, 21000University Medical Centre Ljubljana-Vodnikova cesta 62 | Ljubljana , Slovenia, 1000University Clinical Centre Maribor | Maribor , Slovenia, 2000Chonnam National University Hospital | Gwangju , South Korea, 61469The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul , South Korea, 06591C.H. Regional Reina Sofia - PPDS | Córdoba Córdoba, Spain, 14004Hospital Universitario de Basurto | Bilbao Vizcaya, Spain, 48013Hospital Universitario A Coruña | A Coruña , Spain, 15006Hospital General Universitario Gregorio Marañon | Madrid , Spain, 28007Hospital Universitario 12 de Octubre | Madrid , Spain, 28041Hospital Universitario La Paz - PPDS | Madrid , Spain, 28046Hospital Universitario de Canarias | San Cristóbal de La Laguna , Spain, 38330Fundacio Hospital de l'Esperit Sant | Santa Coloma de Gramenet(Barcelona) , Spain, 08923Hospital Quironsalud Infanta Luisa | Seville , Spain, 41010Hospital Nuestra Señora de Valme | Seville , Spain, 41014Hospital Universitario Araba - Txagorritxu | Vitoria-Gasteiz Álava, Spain, 01009Kaohsiung Medical University - Chung-Ho Memorial Hospital | Kaohsiung City , Taiwan, 807Taichung Veterans General Hospital | Taichung , Taiwan, 407Taipei Medical University Hospital - PPDS | Taipei , Taiwan, 110Chang Gung Memorial Hospital, Linkou | Taoyuan City , Taiwan, 333Chapel Allerton Hospital - PPDS | Leeds , United Kingdom, LS7 4SAWilliam Harvey Research Institute - PPDS | London , United Kingdom, EC1M 6BQ
Investigators
Study Director: MD, Amgen