A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
A 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)
1 other identifier
interventional
434
26 countries
194
Brief Summary
Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives:
- 1.To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS.
- 2.To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS
- 3.To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2024
Typical duration for phase_3
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedStudy Start
First participant enrolled
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 17, 2026
January 8, 2026
December 1, 2025
2.5 years
January 30, 2024
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in ESSPRI score
At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score
At week 48
Secondary Outcomes (16)
Proportion of participants achieving meaningful improvement in DASPRI
At Week 48
Proportion of participants achieving ESSPRI [1.5] response
At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a)
At Week 48
Change from baseline in DASPRI Dryness
At Week 48
Change from baseline in ESSPRI Dryness
At Week 48
- +11 more secondary outcomes
Study Arms (3)
Dazodalibep Dose 1
EXPERIMENTALParticipants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
Dazodalibep Dose 2
EXPERIMENTALParticipants will be administered dose 2 of dazodalibep by IV infusion.
Placebo
PLACEBO COMPARATORParticipants will be administered placebo by IV infusion.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
- Have an ESSPRI score of ≥ 5 at screening.
- Have an ESSDAI score of \< 5 at screening.
- Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
- Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min.
- Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
- Meets all of the following tuberculosis (TB) criteria:
- No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
- No signs or symptoms suggestive of active TB from medical history or physical examination.
- 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).
- 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).
You may not qualify if:
- Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
- History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
- Active malignancy or history of malignancy within the last 5 years, except as follows:
- In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR
- Cutaneous basal cell carcinoma following presumed curative therapy.
- Individuals who are pregnant or lactating or planning to become pregnant during the study.
- Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
- 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.
- Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
- 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.
- Individuals with:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (194)
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, 85392, United States
Arizona Research Clinic PLLC
Chandler, Arizona, 85225-2915, United States
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, 86001-6299, United States
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, 85297-7338, United States
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona, 85306-9800, United States
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona, 85704-1140, United States
Medvin Clinical Research - Covina
Covina, California, 91723, United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, 92037-1337, United States
Inland Rheumatology Clinical Trials Incorporated
Upland, California, 91786-4951, United States
Medvin Clinical Research
Whittier, California, 90602, United States
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado, 80528-3400, United States
Bradenton Research Center Inc
Bradenton, Florida, 34205-1704, United States
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765-2616, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321-2956, United States
BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa, Florida, 33614-7101, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-8500, United States
Tufts Medical Center - Rheumatology Research Office - PPDS
Boston, Massachusetts, 02111-1552, United States
Clinical Research Institute of Michigan, LLC-St. Claire Shores
Saint Clair Shores, Michigan, 48081, United States
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri, 64151-5100, United States
Arthritis, Rheumatic & Bone Disease Associates - P
Voorhees Township, New Jersey, 08043-4509, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102-1710, United States
NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201-5501, United States
Arthritis and Osteoporosis Consultants of The Carolinas
Charlotte, North Carolina, 28207-1100, United States
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, 27710-0001, United States
Onsite Clinical Solutions, LLC - Salisbury
Salisbury, North Carolina, 28144, United States
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg, Ohio, 45342-3585, United States
University of Toledo Medical Center
Toledo, Ohio, 43614-2595, United States
STAT Research-600 Aviator Ct
Vandalia, Ohio, 45377-9474, United States
Low Country Rheumatology PA-Summerville
Summerville, South Carolina, 29486, United States
Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee, 37128, United States
Amarillo Center For Clinical Research
Amarillo, Texas, 79124-1601, United States
Accurate Clinical Management-Baytown
Baytown, Texas, 77521, United States
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, 76051-3143, United States
R & H Clinical Research-777 S Fry Rd
Katy, Texas, 77450-2297, United States
Texas Arthritis & Rheumatology Associates
Katy, Texas, 77450, United States
Valley Arthritis Center
McAllen, Texas, 78501, United States
University of Texas - San Antonio - Health Science Center - PPDS
San Antonio, Texas, 78229-3901, United States
Advanced Rheumatology of Houston - The Woodlands
The Woodlands, Texas, 77382, United States
DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas, 77375, United States
Western Washington Medical Group
Bothell, Washington, 98021-4418, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801-2805, United States
Sanatorio Agote - Swiss Medical Group - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425EOE, Argentina
Sanatorio Guemes
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425EUG, Argentina
Framingham Centro Médico
La Plata, Buenos Aires, B1900, Argentina
Instituto CER S.A.
Quilmes, Buenos Aires, B1878DVB, Argentina
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes, Buenos Aires, B1878GEG, Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, Ciudad Autónoma de BuenosAires, C1121ADC, Argentina
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Buenos Aires, Ciudad Autónoma de BuenosAires, C1426, Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina
DOM Centro de Reumatología
Buenos Aires, C1111AAH, Argentina
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Buenos Aires, C1406AGA, Argentina
Centro Medico Arsema
Buenos Aires, C1427CCL, Argentina
Sanatorio Allende S.A
Córdoba, X5000JHQ, Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, J5400DIL, Argentina
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
UZ Gent
Ghent, 9000, Belgium
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, 40150-150, Brazil
Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, 80030-110, Brazil
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille
Trois-Rivières, Quebec, G9A 3X2, Canada
Clinical Research Chile SpA - PPDS
Valdivia, Los Ríos Region, 5090000, Chile
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña del Mar, Región de Valparaíso, 2520000, Chile
BIOCINETIC Ltda
Peñalolén, Región-MetropolitanadeSantiago, 7910000, Chile
Enroll SpA - Dr. Manuel Barros Borgono - PPDS
Santiago, Región-MetropolitanadeSantiago, Chile
Clinical Center Zagreb - Oncology - Salata 7 - PPDS
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Sveti Duh
Zagreb, City of Zagreb, 10000, Croatia
Polyclinic Bonifarm
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
University Hospital of Split-Spinciceva 1
Split, 21000, Croatia
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, 33000, France
CHU de Brest - Hôpital La Cavale Blanche
Brest, 29609, France
Hopital Emile Muller
Mulhouse, 68100, France
AP-HP - Hôpital Saint Antoine
Paris, 75571, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200, France
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
Bad Doberan, Mecklenburg-Vorpommern, 18209, Germany
Rheumazentrum Greifswald
Greifswald Hansestadt, Mecklenburg-Vorpommern, 17493, Germany
DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein
Chemnitz, 09117, Germany
MVZ Rheuma
Hamburg, 20095, Germany
Laiko General Hospital of Athens
Athens, Attica, 115 27, Greece
University General Hospital of Larissa
Larissa, Larisa, 411 10, Greece
Euromedica Kianous Stavros
Thessaloniki, 546 36, Greece
Bekes Varmegyei Kozponti Korhaz
Gyula, Bekes County, 5700, Hungary
Vasarhelyi Sarkanyfu Kft.
Hódmezővásárhely, Csongrád megye, 6800, Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
Budapest, 1097, Hungary
AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42121, Italy
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, 33100, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 00128, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio, 00168, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Piedmont, 28100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, 37134, Italy
AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco
Catania, 95121, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126, Italy
Chubu Rosai Hospital
Nagoya, Aiti, 455-0018, Japan
Japan Community Health Care Organization (JCHO) Chukyo Hospital
Nagoya, Aiti, 457-0866, Japan
Daido Clinic
Nagoya, Aiti, 457-8511, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaidô, 060-8543, Japan
Hokkaido University Hospital
Sapporo, Hokkaidô, 060-8648, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kita Kyushu-shi, Hukuoka, 807-8556, Japan
Hyogo Medical University Hospital
Nishinomiya-Shi, Hyôgo, 663-8501, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Kanazawa Medical University Hospital
Kahoku, Ishikawa-ken, 920-0293, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, 245-8575, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyôto, 602-8566, Japan
Kyoto University Hospital
Kyoto, Kyôto, 606-8507, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Sasebo Chuo Hospital
Sasebo-Shi, Nagasaki, 857-1165, Japan
Kurashiki Medical Clinic
Kurashiki-Shi, Okayama-ken, 710-0824, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
St. Luke's International Hospital
Chuo-Ku, Tokyo, 104-0044, Japan
Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
Nihon University Itabashi Hospital
tabashi City, Tokyo, 173-8610, Japan
Mediadvance Clinical S.A.P.I. de C.V.
Parques de San Felipe, Chihuahua, 31203, Mexico
CIMAB SA de CV
Torreón Centro, Coahuila, 27000, Mexico
Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali, Estado de Baja California, 21200, Mexico
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
Americana, Jalisco, 44160, Mexico
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City, Mexico City, 6100, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
San Miguel Chapultepec, Mexico City, 11850, Mexico
Oaxaca Site Management Organization - Clinic - OSMO - PPDS
Centro, Oaxaca, 68000, Mexico
Consultorio de Reumatologia
México, 07760, Mexico
Clinstile, S.A. de C.V.
México, Mexico
Hospital Universitario Dr. Jose Eleuterio González
Mitras Centro, 64460, Mexico
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, 64000, Mexico
Optimal Clinical Trials Ltd - PPDS
Auckland, North Island, 1003, New Zealand
Aotearoa Clinical Trials Trust
Auckland, 2025, New Zealand
Waikato Hospital
Hamilton, 3214, New Zealand
Clinica San Antonio S.A.C
Trujillo, La Libertad, 13008, Peru
Clinica San Juan Bautista
San Juan de Lurigancho, Lima region, 15431, Peru
Hogar Clinica San Juan de Dios - Arequipa
Arequipa, 04013, Peru
Hospital Militar Central Luis Arias Schereiber
Lima, 11, Peru
Clínica Internacional San Borja-Avenida Guardia Civil 385
Lima, 15001, Peru
Instituto Peruano del Hueso y la Articulacion S.A.C.
Lima, 15046, Peru
Instituto de Ginecologia y Reproduccion - PPDS
Lima, Lima 33, Peru
Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
Pueblo Libre, Lima 21, Peru
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, 30-149, Poland
FutureMeds - Wroclaw - PPDS
Wroclaw, Lower Silesian Voivodeship, 50-088, Poland
Centrum Medyczne Oporow
Wroclaw, Lower Silesian Voivodeship, 52-416, Poland
ETG Lublin - PPDS
Lublin, Lublin Voivodeship, 20-412, Poland
Reumed Sp. z o.o.
Lublin, Lublin Voivodeship, 20-607, Poland
FutureMeds - Warszawa Centrum - PPDS
Warsaw, Masovian Voivodeship, 00-215, Poland
MICS Centrum Medyczne Warszawa - MICS - PPDS
Warsaw, Masovian Voivodeship, 00-874, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-172, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, Masovian Voivodeship, 02-637, Poland
Klinika Reuma Park sp . zoo Sp.k.
Warsaw, Masovian Voivodeship, 02-665, Poland
K2J2 Medical Center
Wołomin, Masovian Voivodeship, 05-200, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
Malbork, Pomeranian Voivodeship, 82-200, Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Centrum Medyczne Pratia Katowice - PPDS
Katowice, 40-081, Poland
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow, 30-363, Poland
FutureMeds - Lodz - PPDS
Lodz, 91-363, Poland
Twoja Przychodnia PCM
Poznan, 60-324, Poland
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, 04-141, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
Wroclaw, 50-556, Poland
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
Wroclaw, 53-034, Poland
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, 1300-344, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS
Lisbon, 1649-035, Portugal
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
Ponte de Lima, 4990-041, Portugal
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, 4434-502, Portugal
GCM Medical Group, PSC -62 Calle Jose Marti
San Juan, 00917, Puerto Rico
Institute of Rheumatology - PPDS
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
University Clinical Center of Serbia - Pasterova 2 - PPDS
Belgrade, 11000, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Centre of Vojvodina
Novi Sad, 21000, Serbia
Special Hospital For Rheumatic Diseases Novi Sad
Novi Sad, 21000, Serbia
University Medical Centre Ljubljana-Vodnikova cesta 62
Ljubljana, 1000, Slovenia
University Clinical Centre Maribor
Maribor, 2000, Slovenia
Chonnam National University Hospital
Gwangju, 61469, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba, 14004, Spain
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario A Coruña
A Coruña, 15006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38330, Spain
Fundacio Hospital de l'Esperit Sant
Santa Coloma de Gramenet(Barcelona), 08923, Spain
Hospital Quironsalud Infanta Luisa
Seville, 41010, Spain
Hospital Nuestra Señora de Valme
Seville, 41014, Spain
Hospital Universitario Araba - Txagorritxu
Vitoria-Gasteiz, Álava, 01009, Spain
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Taipei Medical University Hospital - PPDS
Taipei, 110, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Chapel Allerton Hospital - PPDS
Leeds, LS7 4SA, United Kingdom
William Harvey Research Institute - PPDS
London, EC1M 6BQ, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 7, 2024
Study Start
April 8, 2024
Primary Completion (Estimated)
October 22, 2026
Study Completion (Estimated)
December 17, 2026
Last Updated
January 8, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.