A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Recruitment Status: RECRUITING
(See Contacts and Locations)Verified March 2026 by Amgen
Sponsor: Amgen
Information Provided by (Responsible Party): Amgen

Clinicaltrials.gov Identifier: NCT06747949
Other Study ID Numbers:: HZNP-DAZ-304

First Submitted: December 18, 2024
First Posted: December 23, 2024
Last Update Posted: April 27, 2026
Last Verified: March 2026

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

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Sjögren's Syndrome	Drug: Dazodalibep

Study Design

Study Type	Interventional
Actual Enrollment	844 participants
Design Allocation	N/A
Interventional Model	Single Group Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
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)
Study Start Date	February 24, 2025
Actual Primary Completion Date	3yrs 4mos from now
Actual Study Completion Date	3yrs 4mos from now

Groups and Cohorts

Group/Cohort	Intervention/Treatment
Dazodalibep Participants 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.	Drug: Dazodalibep Dazodalibep will be given intravenously (IV).

Outcome Measures

Primary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).

Secondary Outcome Measures

Number of Participants with Anti-drug Antibodies (ADAs) During the Study
Plasma Concentration of Dazodalibep

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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.

Contacts and Locations

Sponsors and Collaborators	Amgen
Locations	Arizona Arthritis & Rheumatology Associates - Avondale \| Avondale Arizona, United States, 85392Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln \| Flagstaff Arizona, United States, 86001-6269Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St \| Gilbert Arizona, United States, 85297-7336Arizona 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, 85704-1139Samy Metyas MD Inc \| Covina California, United States, 91723UCSD Altman Clinical and Translational Research Institute Building \| La Jolla California, United States, 92037-1337Tekton 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, 33765-2616BayCare Medical Group Primary Care and Rheumatology - Tampa \| Tampa Florida, United States, 33614-7101Tufts University School of Dental Medicine \| Boston Massachusetts, United States, 02111-1527Shores Rheumatology \| Saint Clair Shores Michigan, United States, 48081-1274Kansas City Physician Partners-8350 N Saint Clair Ave \| Kansas City Missouri, United States, 64151Arthritis, Rheumatic & Bone Disease Associates - Voorhees \| Voorhees Township New Jersey, United States, 08043-4501Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd \| 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, 45377-9474Murfreesboro Medical Clinic Westlawn \| Murfreesboro Tennessee, United States, 37128Accurate Clinical Management-Baytown \| Baytown Texas, United States, 77521-2279Precision Comprehensive Clinical Research Solutions \| Colleyville Texas, United States, 76034-5913R & H Clinical Research-777 S Fry Rd \| Katy Texas, United States, 77450-2297Houston Rheumatology & Arthritis Specialists - PLLC - PPDS \| Katy Texas, United States, 77494-1341Biopharma Informatic - Ridge Road - PPDS \| McAllen Texas, United States, 78503-1527Advanced Rheumatology of Houston \| The Woodlands Texas, United States, 77382-2935DM Clinical Research - Migraine and COPD - PPDS \| Tomball Texas, United States, 77375Western Washington Medical Group, Bothell - Rheumatology \| Bothell Washington, United States, 98021Rheumatology and Pulmonary Clinic \| Beckley West Virginia, United States, 25801-2805Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS \| Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1426ABPInstituto CER S.A. \| Quilmes Buenos Aires, Argentina, B1878DVBInstituto de Investigaciones Clinicas Quilmes SRL \| Quilmes Buenos Aires, Argentina, B1878GEGMR Medicina Reumatologica \| San Fernando Buenos Aires, Argentina, B1646GHPDOM Centro de Reumatología \| Buenos Aires Ciudad Autónoma de BuenosAires, Argentina, C1111Centro de Investigaciones Reumatológicas \| San Miguel de Tucumán Tucumán Province, Argentina, T4000AXLCentro Medico Privado de Reumatologia - PPDS \| San Miguel de Tucumán Tucumán Province, Argentina, T4000AXLClínica Mayo de U.M.C.B. S.R.L \| San Miguel de Tucumán Tucumán Province, Argentina, T4000IHEAprillus Asistencia e Investigacion - Terrada 89 \| Buenos Aires , Argentina, 1406Hospital General de Agudos Dr. José María Ramos Mejia \| Buenos Aires , Argentina, C1121ADCSanatorio Agote - Swiss Medical Group - PPDS \| Buenos Aires , Argentina, C1425EOECentro Medico Arsema \| Buenos Aires , Argentina, C1427CCLSanatorio Allende S.A.-Hipolito Yrigoyen 384 \| Córdoba , Argentina, X5000JHQFramingham Centro Médico \| La Plata , Argentina, B1902COSCentro Polivalente de Asistencia e Investigación Clínica - CER San Juan \| San Juan , Argentina, J5402DILThe 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, 40150-150Centro de Estudos em Terapias Inovadoras \| Curitiba Paraná, Brazil, 80030-110LMK Servicos Medicos SS \| Porto Alegre Rio Grande do Sul, Brazil, 90480-000Clinique de Rhumatologie Du Centre Du Quebec \| Trois-Rivières Quebec, Canada, G8Z 1Y2Centro de Investigacion de Enfermedades Respiratorias e inmunologicas \| Viña del Mar Valparaiso, Chile, 2520000Enroll SpA - Dr. Manuel Barros Borgono - PPDS \| Providencia , Chile, 7500000BIOCINETIC Ltda \| Santiago , Chile, 8350595Centro de especialidades médicas Vanguardia \| Temuco , Chile, 4810345Clinical Research Chile SpA - PPDS \| Valdivia , Chile, 5110683Polyclinic Bonifarm \| Zagreb City of Zagreb, Croatia, 10000University Hospital of Split \| Split , Croatia, 21000CHU de Bordeaux - Hôpital Saint-André \| Bordeaux , France, 33000CHU de Brest - Hôpital La Cavale Blanche \| Brest , France, 29200GHRMSA - Hôpital Emile Muller \| Mulhouse , France, 68100AP-HP - Hôpital Saint Antoine \| Paris , France, 75012Hôpitaux Universitaires de Strasbourg \| Strasbourg , France, 67091University 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, 17493MVZ Rheuma \| Hamburg , Germany, 20095Naval Hospital of Athens \| Athens Attica, Greece, 115 21Laiko 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. \| Hódmezovásárhely Csongrád megye, Hungary, 6800Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus \| Debrecen Hajdú-Bihar, Hungary, 4032Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7 \| Budapest , Hungary, 1097Meir Medical Center \| Kafr Saba Central District, Israel, 4428164The Chaim Sheba Medical Center - PPDS \| Ramat Gan Tel Aviv, Israel, 5262100Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia \| Udine Friuli Venezia Giulia, Italy, 33100Fondazione Policlinico Universitario A Gemelli - Rome - PPDS \| Rome Lazio, Italy, 00168Fondazione Policlinico Universitario Campus Bio-Medico \| Rome Lazio, Italy, 128Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico \| Milan Lombardy, Italy, 20122A.O.U. Città della Salute e della Scienza di Torino \| Turin Piedmont, Italy, 10126Azienda Ospedaliera Universitaria Integrata Di Verona \| Verona Veneto, Italy, 37126Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara \| Pisa , Italy, 56126AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova \| Reggio Emilia , Italy, 42123Chubu Rosai Hospital \| Nagoya-shi Akita, Japan, 455-0018Japan Community Health Care Organization (JCHO) Chukyo Hospital \| Nagoya-shi Akita, Japan, 457-0866Daido Clinic \| Nagoya Akita, 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, 807-8556University 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 Moroyama-Machi Saitama, Japan, 350-0451Hamamatsu University Hospital \| Hamamatsu Shizuoka, Japan, 431-3192St. Luke's International Hospital \| Chuo-Ku Tokyo, Japan, 104-0044Nihon University Itabashi Hospital \| Itabashi-Ku Tokyo, Japan, 173-0032Tokyo Medical Center \| Meguro-Ku Tokyo, Japan, 152-0021Keio University Hospital \| Shinjuku-Ku Tokyo, Japan, 160-8582Mediadvance Clinical S.A.P.I. de C.V. \| Parques de San Felipe Chihuahua, Mexico, 31203Centro de Investigación en Artritis y Osteoporosis - PPDS \| Mexicali Estado de Baja California, Mexico, 21200Centro de Estudios de Investigacion Basica Y Clinica SC \| Guadalajara Jalisco, Mexico, 44690Centro de Investigación y Tratamiento Reumatológico S.C \| Mexico City Mexico City, Mexico, 11850Cryptex Investigación Clínica, S.A. de C.V. \| Mexico City Mexico City, Mexico, 6100Clinstile, S.A. de C.V. \| Mexico City , Mexico, 6700Unidad de Atención Medica e Investigación en Salud \| Mérida , Mexico, 97000Consultorio de Reumatologia \| México , Mexico, 7760Optimal Clinical Trials Ltd - PPDS \| Auckland North Island, New Zealand, 1003Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital) \| Hamilton , New Zealand, 3240Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS \| Papatoetoe , New Zealand, 2025Clinica San Antonio S.A.C \| Trujillo La Libertad, Peru, 13008Medicentro Biociencias Peru S.R.L. \| Pueblo Libre Lima region, Peru, 1508Hospital Militar Central Luis Arias Schereiber \| Jesus Maria , Peru, 15001Instituto de Ginecologia y Reproduccion - PPDS \| Santiago de Surco , Peru, 33Pratia Poznan - PPDS \| Poznan Greater Poland Voivodeship, Poland, 60-192Med-Polonia Sp. z o.o. \| Poznan Greater Poland Voivodeship, Poland, 60-693Malopolskie Centrum Kliniczne \| Krakow Lesser Poland Voivodeship, Poland, 30-149Centrum Medyczne Oporow \| Wroclaw Lower Silesian Voivodeship, Poland, 52-416ETG Lublin - PPDS \| Lublin Lublin Voivodeship, Poland, 20-412Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4 \| Lublin Lublin Voivodeship, Poland, 20-607MICS Centrum Medyczne Warszawa, Wronia - MICS \| Warsaw Masovian Voivodeship, Poland, 00-874MTZ Clinical Research Powered by PRATIA - PPDS \| Warsaw Masovian Voivodeship, Poland, 02-172Centrum Medyczne Reuma Park \| Warsaw Masovian Voivodeship, Poland, 02-665WIM-PIB, Centralny Szpital Kliniczny MON \| Warsaw Masovian Voivodeship, Poland, 04-141Centrum Medyczne K2J2 - Wołomin \| Wołomin Masovian Voivodeship, Poland, 05-200Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o. \| Malbork Pomeranian Voivodeship, Poland, 82-200MICS Centrum Medyczne Bydgoszcz \| Bydgoszcz , Poland, 85-065Szpital 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, 30-363Centrum Medyczne PROMED- Olszanska 5G \| Krakow , Poland, 31-513FutureMeds - Lodz - PPDS \| Lodz , Poland, 91-363Twoja Przychodnia PCM \| Poznan , Poland, 60-324Prywatna Praktyka Lekarska Pawel Hrycaj \| Poznan , Poland, 61-397Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher \| Warsaw , Poland, 02-637ETG Warszawa - PPDS \| Warsaw , Poland, 02-677FutureMeds - Targowek - PPDS \| Warsaw , Poland, 03-291Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213 \| Wroclaw , Poland, 50-556Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3 \| Wroclaw , Poland, 53-034FutureMeds - Wroclaw - PPDS \| Wroclaw , Poland, 53-673ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz \| Lisbon Lisbon District, Portugal, 1349-019ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS \| Lisbon Lisbon District, Portugal, 1649-035Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima \| Ponte de Lima , Portugal, 4990-150ULS de Gaia/Espinho, EPE - Unidade I \| Vila Nova de Gaia , Portugal, 4434-502Military Medical Academy \| Belgrade Belgrade, Serbia, 11000Institute of Rheumatology - PPDS \| Belgrade , Serbia, 11000Klinika za Alergologiju i Imunologiju \| Belgrade , Serbia, 112108University Clinical Center Kragujevac \| Kragujevac , Serbia, 34000Clinical Centre of Vojvodina \| Novi Sad , Serbia, 21000Special Hospital For Rheumatic Diseases Novi Sad \| Novi Sad , Serbia, 21000University Clinical Centre Maribor \| Maribor , Slovenia, 2000The Catholic University of Korea, Seoul St. Mary's Hospital \| Seoul Seoul Teugbyeolsi, South Korea, 6591Fundacio Hospital de l'Esperit Sant \| Santa Coloma de Gramenet Barcelona, Spain, 08923C.H. Regional Reina Sofia - PPDS \| Córdoba Córdoba, Spain, 14004Hospital Universitario de Basurto \| Bilbao Vizcaya, Spain, 48013Hospital Universitario Infanta Leonor \| Madrid , Spain, 28031Hospital Universitario 12 de Octubre \| Madrid , Spain, 28041Hospital Quironsalud Infanta Luisa \| Seville , Spain, 41010Hospital Universitario de Valme \| Seville , Spain, 41014Kaohsiung Medical University - Chung-Ho Memorial Hospital \| Kaohsiung City , Taiwan, 80756Taichung Veterans General Hospital \| Taichung , Taiwan, 40705Taipei Medical University Hospital - PPDS \| Taipei , Taiwan, 11031Chang Gung Memorial Hospital, Linkou \| Taoyuan , Taiwan, 33305Queen Alexandra Hospital \| Portsmouth Hampshire, United Kingdom, PO6 3LYChapel Allerton Hospital - PPDS \| Leeds , United Kingdom, LS7 4SAMile End Hospital - PPDS \| London , United Kingdom, E1 4DG
Investigators	Study Director: MD, Amgen

More Information

Additional Relevant MeSH Terms

Sjogren's SyndromeArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases