A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)
3 other identifiers
interventional
844
26 countries
174
Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2025
Longer than P75 for phase_3
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 24, 2024
CompletedStudy Start
First participant enrolled
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 11, 2029
April 28, 2026
April 1, 2026
4.8 years
December 19, 2024
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
Up to 152 weeks
Secondary Outcomes (2)
Number of Participants with Anti-drug Antibodies (ADAs) During the Study
Up to 132 weeks
Plasma Concentration of Dazodalibep
Up to 132 weeks
Study Arms (1)
Dazodalibep
EXPERIMENTALParticipants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all the following criteria apply:
- Participant has provided informed consent before initiation of any study specific activities/procedures.
- Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
- Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
- Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.
- Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration.
- Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
- Individuals who plan to receive live (attenuated) vaccine during the LTE study.
- Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
- Female participants who are pregnant or lactating or planning to become pregnant during the study.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (174)
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, 85392, United States
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, 86001-6269, United States
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, 85297-7336, 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, 85704-1139, United States
Samy Metyas MD Inc
Covina, California, 91723, United States
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, 92037-1337, 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
BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa, Florida, 33614-7101, United States
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111-1527, United States
Shores Rheumatology
Saint Clair Shores, Michigan, 48081-1274, United States
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri, 64151, United States
Arthritis, Rheumatic & Bone Disease Associates - Voorhees
Voorhees Township, New Jersey, 08043-4501, United States
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
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
Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee, 37128, United States
Accurate Clinical Management-Baytown
Baytown, Texas, 77521-2279, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034-5913, United States
R & H Clinical Research-777 S Fry Rd
Katy, Texas, 77450-2297, United States
Houston Rheumatology & Arthritis Specialists - PLLC - PPDS
Katy, Texas, 77494-1341, United States
Biopharma Informatic - Ridge Road - PPDS
McAllen, Texas, 78503-1527, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382-2935, United States
DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas, 77375, United States
Western Washington Medical Group, Bothell - Rheumatology
Bothell, Washington, 98021, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801-2805, United States
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
Instituto CER S.A.
Quilmes, Buenos Aires, B1878DVB, Argentina
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes, Buenos Aires, B1878GEG, Argentina
MR Medicina Reumatologica
San Fernando, Buenos Aires, B1646GHP, Argentina
DOM Centro de Reumatología
Buenos Aires, Ciudad Autónoma de BuenosAires, C1111, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Centro Medico Privado de Reumatologia - PPDS
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
Aprillus Asistencia e Investigacion - Terrada 89
Buenos Aires, 1406, Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, C1121ADC, Argentina
Sanatorio Agote - Swiss Medical Group - PPDS
Buenos Aires, C1425EOE, Argentina
Centro Medico Arsema
Buenos Aires, C1427CCL, Argentina
Sanatorio Allende S.A.-Hipolito Yrigoyen 384
Córdoba, X5000JHQ, Argentina
Framingham Centro Médico
La Plata, B1902COS, Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, J5402DIL, 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
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, 80030-110, Brazil
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Clinique de Rhumatologie Du Centre Du Quebec
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña del Mar, Valparaiso, 2520000, Chile
Enroll SpA - Dr. Manuel Barros Borgono - PPDS
Providencia, 7500000, Chile
BIOCINETIC Ltda
Santiago, 8350595, Chile
Centro de especialidades médicas Vanguardia
Temuco, 4810345, Chile
Clinical Research Chile SpA - PPDS
Valdivia, 5110683, Chile
Polyclinic Bonifarm
Zagreb, City of Zagreb, 10000, Croatia
University Hospital of Split
Split, 21000, Croatia
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, 33000, France
CHU de Brest - Hôpital La Cavale Blanche
Brest, 29200, France
GHRMSA - Hôpital Emile Muller
Mulhouse, 68100, France
AP-HP - Hôpital Saint Antoine
Paris, 75012, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, 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
MVZ Rheuma
Hamburg, 20095, Germany
Naval Hospital of Athens
Athens, Attica, 115 21, Greece
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.
Hódmezovásárhely, Csongrád megye, 6800, Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar, 4032, Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
Budapest, 1097, Hungary
Meir Medical Center
Kafr Saba, Central District, 4428164, Israel
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, 5262100, Israel
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, 33100, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio, 00168, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 128, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
A.O.U. Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, 37126, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126, Italy
AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
Chubu Rosai Hospital
Nagoya-shi, Akita, 455-0018, Japan
Japan Community Health Care Organization (JCHO) Chukyo Hospital
Nagoya-shi, Akita, 457-0866, Japan
Daido Clinic
Nagoya, Akita, 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
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 Moroyama-Machi, Saitama, 350-0451, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
St. Luke's International Hospital
Chuo-Ku, Tokyo, 104-0044, Japan
Nihon University Itabashi Hospital
Itabashi-Ku, Tokyo, 173-0032, Japan
Tokyo Medical Center
Meguro-Ku, Tokyo, 152-0021, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
Mediadvance Clinical S.A.P.I. de C.V.
Parques de San Felipe, Chihuahua, 31203, Mexico
Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali, Estado de Baja California, 21200, Mexico
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco, 44690, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, Mexico City, 11850, Mexico
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City, Mexico City, 6100, Mexico
Clinstile, S.A. de C.V.
Mexico City, 6700, Mexico
Unidad de Atención Medica e Investigación en Salud
Mérida, 97000, Mexico
Consultorio de Reumatologia
México, 7760, Mexico
Optimal Clinical Trials Ltd - PPDS
Auckland, North Island, 1003, New Zealand
Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
Hamilton, 3240, New Zealand
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
Papatoetoe, 2025, New Zealand
Clinica San Antonio S.A.C
Trujillo, La Libertad, 13008, Peru
Medicentro Biociencias Peru S.R.L.
Pueblo Libre, Lima region, 1508, Peru
Hospital Militar Central Luis Arias Schereiber
Jesus Maria, 15001, Peru
Instituto de Ginecologia y Reproduccion - PPDS
Santiago de Surco, 33, Peru
Pratia Poznan - PPDS
Poznan, Greater Poland Voivodeship, 60-192, Poland
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-693, Poland
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, 30-149, Poland
Centrum Medyczne Oporow
Wroclaw, Lower Silesian Voivodeship, 52-416, Poland
ETG Lublin - PPDS
Lublin, Lublin Voivodeship, 20-412, Poland
Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
Lublin, Lublin Voivodeship, 20-607, Poland
MICS Centrum Medyczne Warszawa, Wronia - MICS
Warsaw, Masovian Voivodeship, 00-874, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-172, Poland
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, 02-665, Poland
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, 04-141, Poland
Centrum Medyczne K2J2 - Wołomin
Wołomin, Masovian Voivodeship, 05-200, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
Malbork, Pomeranian Voivodeship, 82-200, Poland
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065, 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
Centrum Medyczne PROMED- Olszanska 5G
Krakow, 31-513, Poland
FutureMeds - Lodz - PPDS
Lodz, 91-363, Poland
Twoja Przychodnia PCM
Poznan, 60-324, Poland
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan, 61-397, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, 02-637, Poland
ETG Warszawa - PPDS
Warsaw, 02-677, Poland
FutureMeds - Targowek - PPDS
Warsaw, 03-291, 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
FutureMeds - Wroclaw - PPDS
Wroclaw, 53-673, Poland
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, Lisbon District, 1349-019, Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, Lisbon District, 1649-035, Portugal
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
Ponte de Lima, 4990-150, Portugal
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, 4434-502, Portugal
Military Medical Academy
Belgrade, Belgrade, 11000, Serbia
Institute of Rheumatology - PPDS
Belgrade, 11000, Serbia
Klinika za Alergologiju i Imunologiju
Belgrade, 112108, 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 Clinical Centre Maribor
Maribor, 2000, Slovenia
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, 6591, South Korea
Fundacio Hospital de l'Esperit Sant
Santa Coloma de Gramenet, Barcelona, 08923, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba, 14004, Spain
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Quironsalud Infanta Luisa
Seville, 41010, Spain
Hospital Universitario de Valme
Seville, 41014, Spain
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Medical University Hospital - PPDS
Taipei, 11031, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 33305, Taiwan
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Chapel Allerton Hospital - PPDS
Leeds, LS7 4SA, United Kingdom
Mile End Hospital - PPDS
London, E1 4DG, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
December 24, 2024
Study Start
February 25, 2025
Primary Completion (Estimated)
December 11, 2029
Study Completion (Estimated)
December 11, 2029
Last Updated
April 28, 2026
Record last verified: 2026-04
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 were 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.