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A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
NCT06747949 · Amgen
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Official title
A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)
About this study
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Eligibility criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Study design
Enrollment target: 844 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-25
Estimated completion: 2029-12-11
Last updated: 2026-04-07
Interventions
Drug: Dazodalibep
Primary outcomes
- • Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to 152 weeks)
Sponsor
Amgen · industry
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (168)
Arizona Arthritis & Rheumatology Associates - AvondaleRecruiting
Avondale, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais LnRecruiting
Flagstaff, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome StRecruiting
Gilbert, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly LnRecruiting
Glendale, Arizona, United States
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove RdRecruiting
Tucson, Arizona, United States
Samy Metyas MD IncRecruiting
Covina, California, United States
UCSD Altman Clinical and Translational Research Institute BuildingRecruiting
La Jolla, California, United States
Tekton Research, LLC - 2121 E Harmony Rd - PPDSRecruiting
Fort Collins, Colorado, United States
Bradenton Research Center IncRecruiting
Bradenton, Florida, United States
Clinical Research of West Florida Inc - ClearwaterRecruiting
Clearwater, Florida, United States
BayCare Medical Group Primary Care and Rheumatology - TampaRecruiting
Tampa, Florida, United States
Tufts University School of Dental MedicineRecruiting
Boston, Massachusetts, United States
Shores RheumatologyRecruiting
Saint Clair Shores, Michigan, United States
Kansas City Physician Partners-8350 N Saint Clair AveRecruiting
Kansas City, Missouri, United States
Arthritis, Rheumatic & Bone Disease Associates - VoorheesRecruiting
Voorhees Township, New Jersey, United States
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph RdRecruiting
Charlotte, North Carolina, United States
Duke Early Phase Clinical Research Unit - PPDSRecruiting
Durham, North Carolina, United States
Onsite Clinical Solutions, LLC - SalisburyRecruiting
Salisbury, North Carolina, United States
Arthritis & Osteoporosis Center of Southwest Ohio - MiamisburgRecruiting
Miamisburg, Ohio, United States
University of Toledo Medical CenterRecruiting
Toledo, Ohio, United States
STAT Research-600 Aviator CtRecruiting
Vandalia, Ohio, United States
Murfreesboro Medical Clinic WestlawnRecruiting
Murfreesboro, Tennessee, United States
Accurate Clinical Management-BaytownRecruiting
Baytown, Texas, United States
Precision Comprehensive Clinical Research SolutionsRecruiting
Colleyville, Texas, United States
R & H Clinical Research-777 S Fry RdRecruiting
Katy, Texas, United States
Houston Rheumatology & Arthritis Specialists - PLLC - PPDSRecruiting
Katy, Texas, United States
Biopharma Informatic - Ridge Road - PPDSRecruiting
McAllen, Texas, United States
Advanced Rheumatology of HoustonRecruiting
The Woodlands, Texas, United States
DM Clinical Research - Migraine and COPD - PPDSRecruiting
Tomball, Texas, United States
Western Washington Medical Group, Bothell - RheumatologyRecruiting
Bothell, Washington, United States
Rheumatology and Pulmonary ClinicRecruiting
Beckley, West Virginia, United States
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDSRecruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto CER S.A.Recruiting
Quilmes, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes SRLRecruiting
Quilmes, Buenos Aires, Argentina
DOM Centro de ReumatologíaRecruiting
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Centro de Investigaciones ReumatológicasRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Medico Privado de Reumatologia - PPDSRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Clínica Mayo de U.M.C.B. S.R.LRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Aprillus Asistencia e Investigacion - Terrada 89Recruiting
Buenos Aires, Argentina
Hospital General de Agudos Dr. José María Ramos MejiaRecruiting
Buenos Aires, Argentina
Sanatorio Agote - Swiss Medical Group - PPDSRecruiting
Buenos Aires, Argentina
Centro Medico ArsemaRecruiting
Buenos Aires, Argentina
Sanatorio Allende S.A.-Hipolito Yrigoyen 384Recruiting
Córdoba, Argentina
Framingham Centro MédicoRecruiting
La Plata, Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER San JuanRecruiting
San Juan, Argentina
The Queen Elizabeth HospitalRecruiting
Woodville South, South Australia, Australia
UZ GentRecruiting
Ghent, Belgium
SER - Serviços Especializados em Reumatologia da Bahia S/S - MERecruiting
Salvador, Estado de Bahia, Brazil
Centro de Estudos em Terapias InovadorasRecruiting
Curitiba, Paraná, Brazil
LMK Servicos Medicos SSRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Clinique de Rhumatologie Du Centre Du QuebecRecruiting
Trois-Rivières, Quebec, Canada
Centro de Investigacion de Enfermedades Respiratorias e inmunologicasRecruiting
Viña del Mar, Valparaiso, Chile
Enroll SpA - Dr. Manuel Barros Borgono - PPDSRecruiting
Providencia, Chile
BIOCINETIC LtdaRecruiting
Santiago, Chile
Clinical Research Chile SpA - PPDSRecruiting
Valdivia, Chile
Polyclinic BonifarmRecruiting
Zagreb, City of Zagreb, Croatia
University Hospital of SplitRecruiting
Split, Croatia
CHU de Bordeaux - Hôpital Saint-AndréRecruiting
Bordeaux, France
CHU de Brest - Hôpital La Cavale BlancheRecruiting
Brest, France
GHRMSA - Hôpital Emile MullerRecruiting
Mulhouse, France
AP-HP - Hôpital Saint AntoineRecruiting
Paris, France
Hôpitaux Universitaires de StrasbourgRecruiting
Strasbourg, France
University Clinic HeidelbergRecruiting
Heidelberg, Baden-Wurttemberg, Germany
Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad DoberanRecruiting
Bad Doberan, Mecklenburg-Vorpommern, Germany
Rheumazentrum GreifswaldRecruiting
Greifswald Hansestadt, Mecklenburg-Vorpommern, Germany
MVZ RheumaRecruiting
Hamburg, Germany
Naval Hospital of AthensRecruiting
Athens, Attica, Greece
University General Hospital of LarissaRecruiting
Larissa, Larisa, Greece
Euromedica Kianous StavrosRecruiting
Thessaloniki, Greece
Bekes Varmegyei Kozponti KorhazRecruiting
Gyula, Bekes County, Hungary
Vasarhelyi Sarkanyfu Kft.Recruiting
Hódmezovásárhely, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei CampusRecruiting
Debrecen, Hajdú-Bihar, Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7Recruiting
Budapest, Hungary
Meir Medical CenterRecruiting
Kafr Saba, Central District, Israel
The Chaim Sheba Medical Center - PPDSRecruiting
Ramat Gan, Tel Aviv, Israel
Fondazione Policlinico Universitario A Gemelli - Rome - PPDSRecruiting
Rome, Lazio, Italy
Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Lombardy, Italy
A.O.U. Città della Salute e della Scienza di TorinoRecruiting
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Integrata Di VeronaRecruiting
Verona, Veneto, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa ChiaraRecruiting
Pisa, Italy
AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria NuovaRecruiting
Reggio Emilia, Italy
Chubu Rosai HospitalRecruiting
Nagoya-shi, Akita, Japan
Japan Community Health Care Organization (JCHO) Chukyo HospitalRecruiting
Nagoya-shi, Akita, Japan
Sapporo Medical University HospitalRecruiting
Sapporo, Hokkaidô, Japan
Hokkaido University HospitalRecruiting
Sapporo, Hokkaidô, Japan
Hospital of the University of Occupational and Environmental Health, JapanRecruiting
Kita Kyushu-shi, Hukuoka, Japan
University of Tsukuba HospitalRecruiting
Tsukuba, Ibaraki, Japan
Kanazawa Medical University HospitalRecruiting
Kahoku, Ishikawa-ken, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Ishikawa-ken, Japan
National Hospital Organization Yokohama Medical CenterRecruiting
Yokohama, Kanagawa, Japan
University Hospital, Kyoto Prefectural University of MedicineRecruiting
Kyoto, Kyôto, Japan
Kyoto University HospitalRecruiting
Kyoto, Kyôto, Japan
Nagasaki University HospitalRecruiting
Nagasaki, Nagasaki, Japan
Sasebo Chuo HospitalRecruiting
Sasebo-Shi, Nagasaki, Japan
Kurashiki Medical ClinicRecruiting
Kurashiki-Shi, Okayama-ken, Japan
Saitama Medical University HospitalRecruiting
Iruma-Gun Moroyama-Machi, Saitama, Japan
Hamamatsu University HospitalRecruiting
Hamamatsu, Shizuoka, Japan
St. Luke's International HospitalRecruiting
Chuo-Ku, Tokyo, Japan
Nihon University Itabashi HospitalRecruiting
Itabashi-Ku, Tokyo, Japan
Tokyo Medical CenterRecruiting
Meguro-Ku, Tokyo, Japan
Keio University HospitalRecruiting
Shinjuku-Ku, Tokyo, Japan
Mediadvance Clinical S.A.P.I. de C.V.Recruiting
Parques de San Felipe, Chihuahua, Mexico
Centro de Investigación en Artritis y Osteoporosis - PPDSRecruiting
Mexicali, Estado de Baja California, Mexico
Centro de Investigación y Tratamiento Reumatológico S.CRecruiting
Mexico City, Mexico City, Mexico
Cryptex Investigación Clínica, S.A. de C.V.Recruiting
Mexico City, Mexico City, Mexico
Clinstile, S.A. de C.V.Recruiting
Mexico City, Mexico
Unidad de Atención Medica e Investigación en SaludRecruiting
Mérida, Mexico
Consultorio de ReumatologiaRecruiting
México, Mexico
Optimal Clinical Trials Ltd - PPDSRecruiting
Auckland, North Island, New Zealand
Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)Recruiting
Hamilton, New Zealand
Aotearoa Clinical Trials Trust- Middlemore HospitalRecruiting
Papatoetoe, New Zealand
Clinica San Antonio S.A.CRecruiting
Trujillo, La Libertad, Peru
Medicentro Biociencias Peru S.R.L.Recruiting
Pueblo Libre, Lima region, Peru
Hospital Militar Central Luis Arias SchereiberRecruiting
Jesus Maria, Peru
Instituto de Ginecologia y Reproduccion - PPDSRecruiting
Santiago de Surco, Peru
Pratia Poznan - PPDSRecruiting
Poznan, Greater Poland Voivodeship, Poland
Med-Polonia Sp. z o.o.Recruiting
Poznan, Greater Poland Voivodeship, Poland
Malopolskie Centrum KliniczneRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne OporowRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
ETG Lublin - PPDSRecruiting
Lublin, Lublin Voivodeship, Poland
Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4Recruiting
Lublin, Lublin Voivodeship, Poland
MICS Centrum Medyczne Warszawa - MICS - PPDSRecruiting
Warsaw, Masovian Voivodeship, Poland
MTZ Clinical Research Powered by PRATIA - PPDSRecruiting
Warsaw, Masovian Voivodeship, Poland
ARS RHEUMATICA Sp. z o.o.Recruiting
Warsaw, Masovian Voivodeship, Poland
WIM-PIB, Centralny Szpital Kliniczny MONRecruiting
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne K2J2 - WołominRecruiting
Wołomin, Masovian Voivodeship, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.Recruiting
Malbork, Pomeranian Voivodeship, Poland
MICS Centrum Medyczne BydgoszczRecruiting
Bydgoszcz, Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w BydgoszczyRecruiting
Bydgoszcz, Poland
Centrum Medyczne Pratia Katowice - PPDSRecruiting
Katowice, Poland
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowaRecruiting
Krakow, Poland
Centrum Medyczne PROMED- Olszanska 5GRecruiting
Krakow, Poland
FutureMeds - Lodz - PPDSRecruiting
Lodz, Poland
Twoja Przychodnia PCMRecruiting
Poznan, Poland
Prywatna Praktyka Lekarska Pawel HrycajRecruiting
Poznan, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory ReicherRecruiting
Warsaw, Poland
ETG Warszawa - PPDSRecruiting
Warsaw, Poland
FutureMeds - Targowek - PPDSRecruiting
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213Recruiting
Wroclaw, Poland
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3Recruiting
Wroclaw, Poland
FutureMeds - Wroclaw - PPDSRecruiting
Wroclaw, Poland
ULS de Lisboa Ocidental, EPE - Hospital Egas MonizRecruiting
Lisbon, Lisbon District, Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDSRecruiting
Lisbon, Lisbon District, Portugal
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de LimaRecruiting
Ponte de Lima, Portugal
ULS de Gaia/Espinho, EPE - Unidade IRecruiting
Vila Nova de Gaia, Portugal
Military Medical AcademyRecruiting
Belgrade, Belgrade, Serbia
Institute of Rheumatology - PPDSRecruiting
Belgrade, Serbia
Klinika za Alergologiju i ImunologijuRecruiting
Belgrade, Serbia
University Clinical Center KragujevacRecruiting
Kragujevac, Serbia
Clinical Centre of VojvodinaRecruiting
Novi Sad, Serbia
Special Hospital For Rheumatic Diseases Novi SadRecruiting
Novi Sad, Serbia
University Clinical Centre MariborRecruiting
Maribor, Slovenia
The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Fundacio Hospital de l'Esperit SantRecruiting
Santa Coloma de Gramenet, Barcelona, Spain
C.H. Regional Reina Sofia - PPDSRecruiting
Córdoba, Córdoba, Spain
Hospital Universitario de BasurtoRecruiting
Bilbao, Vizcaya, Spain
Hospital Universitario Infanta LeonorRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Quironsalud Infanta LuisaRecruiting
Seville, Spain
Hospital Universitario de ValmeRecruiting
Seville, Spain
Kaohsiung Medical University - Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
Taipei Medical University Hospital - PPDSRecruiting
Taipei, Taiwan
Chang Gung Memorial Hospital, LinkouRecruiting
Taoyuan District, Taiwan
Queen Alexandra HospitalRecruiting
Portsmouth, Hampshire, United Kingdom
Chapel Allerton Hospital - PPDSRecruiting
Leeds, United Kingdom
Mile End Hospital - PPDSRecruiting
London, United Kingdom