Sjögren's SyndromePhase 3NCT06747949
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
A Phase 3 study testing Dazodalibep in people with Sjögren's Syndrome, run by Amgen at 174 sites in 26 countries.
Trial summary
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- Dazodalibep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 844 participants
- Where
- 174 sitesin 26 countries
- Study dates
- 25 Feb 2025to 11 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
174 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
174 sites in 26 countries
United States31 sites, 31 recruiting
- Recruiting
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, 85392
- Recruiting
Accurate Clinical Management-Baytown
Baytown, Texas, 77521-2279
- Recruiting
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801-2805
- Recruiting
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111-1527
- Recruiting
Western Washington Medical Group, Bothell - Rheumatology
Bothell, Washington, 98021
- Recruiting
Bradenton Research Center Inc
Bradenton, Florida, 34205-1704
- Recruiting
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
Charlotte, North Carolina, 28207-1100
- Recruiting
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765-2616
- Recruiting
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034-5913
- Recruiting
Samy Metyas MD Inc
Covina, California, 91723
- Recruiting
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, 27710-0001
- Recruiting
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff, Arizona, 86001-6269
- Recruiting
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins, Colorado, 80528-3400
- Recruiting
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert, Arizona, 85297-7336
- Recruiting
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale, Arizona, 85306-9800
- Recruiting
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City, Missouri, 64151
- Recruiting
R & H Clinical Research-777 S Fry Rd
Katy, Texas, 77450-2297
- Recruiting
Houston Rheumatology & Arthritis Specialists - PLLC - PPDS
Katy, Texas, 77494-1341
- Recruiting
UCSD Altman Clinical and Translational Research Institute Building
La Jolla, California, 92037-1337
- Recruiting
Biopharma Informatic - Ridge Road - PPDS
McAllen, Texas, 78503-1527
- Recruiting
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg, Ohio, 45342-3585
- Recruiting
Murfreesboro Medical Clinic Westlawn
Murfreesboro, Tennessee, 37128
- Recruiting
Shores Rheumatology
Saint Clair Shores, Michigan, 48081-1274
- Recruiting
Onsite Clinical Solutions, LLC - Salisbury
Salisbury, North Carolina, 28144
- Recruiting
BayCare Medical Group Primary Care and Rheumatology - Tampa
Tampa, Florida, 33614-7101
- Recruiting
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382-2935
- Recruiting
University of Toledo Medical Center
Toledo, Ohio, 43614-2595
- Recruiting
DM Clinical Research - Migraine and COPD - PPDS
Tomball, Texas, 77375
- Recruiting
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson, Arizona, 85704-1139
- Recruiting
STAT Research-600 Aviator Ct
Vandalia, Ohio, 45377-9474
- Recruiting
Arthritis, Rheumatic & Bone Disease Associates - Voorhees
Voorhees Township, New Jersey, 08043-4501
Poland26 sites, 26 recruiting
- Recruiting
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
- Recruiting
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
- Recruiting
Centrum Medyczne Pratia Katowice - PPDS
Katowice, 40-081
- Recruiting
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, 30-149
- Recruiting
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow, 30-363
- Recruiting
Centrum Medyczne PROMED- Olszanska 5G
Krakow, 31-513
- Recruiting
FutureMeds - Lodz - PPDS
Lodz, 91-363
- Recruiting
ETG Lublin - PPDS
Lublin, Lublin Voivodeship, 20-412
- Recruiting
Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
Lublin, Lublin Voivodeship, 20-607
- Recruiting
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
Malbork, Pomeranian Voivodeship, 82-200
- Recruiting
Pratia Poznan - PPDS
Poznan, Greater Poland Voivodeship, 60-192
- Recruiting
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-693
- Recruiting
Twoja Przychodnia PCM
Poznan, 60-324
- Recruiting
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan, 61-397
- Recruiting
MICS Centrum Medyczne Warszawa, Wronia - MICS
Warsaw, Masovian Voivodeship, 00-874
- Recruiting
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-172
- Recruiting
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, 02-665
- Recruiting
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, 04-141
- Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, 02-637
- Recruiting
ETG Warszawa - PPDS
Warsaw, 02-677
- Recruiting
FutureMeds - Targowek - PPDS
Warsaw, 03-291
- Recruiting
Centrum Medyczne K2J2 - Wołomin
Wołomin, Masovian Voivodeship, 05-200
- Recruiting
Centrum Medyczne Oporow
Wroclaw, Lower Silesian Voivodeship, 52-416
- Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
Wroclaw, 50-556
- Recruiting
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
Wroclaw, 53-034
- Recruiting
FutureMeds - Wroclaw - PPDS
Wroclaw, 53-673
Japan21 sites, 21 recruiting
- Recruiting
St. Luke's International Hospital
Chuo-Ku, Tokyo, 104-0044
- Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
- Recruiting
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi, Saitama, 350-0451
- Recruiting
Kanazawa Medical University Hospital
Kahoku, Ishikawa-ken, 920-0293
- Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan
Kita Kyushu-shi, Hukuoka, 807-8556
- Recruiting
Kurashiki Medical Clinic
Kurashiki-Shi, Okayama-ken, 710-0824
- Recruiting
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyôto, 602-8566
- Recruiting
Kyoto University Hospital
Kyoto, Kyôto, 606-8507
- Recruiting
Tokyo Medical Center
Meguro-Ku, Tokyo, 152-0021
- Recruiting
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
- Recruiting
Daido Clinic
Nagoya, Akita, 457-8511
- Recruiting
Chubu Rosai Hospital
Nagoya-shi, Akita, 455-0018
- Recruiting
Japan Community Health Care Organization (JCHO) Chukyo Hospital
Nagoya-shi, Akita, 457-0866
- Recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaidô, 060-8543
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaidô, 060-8648
- Recruiting
Sasebo Chuo Hospital
Sasebo-Shi, Nagasaki, 857-1165
- Recruiting
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
- Recruiting
Nihon University Itabashi Hospital
tabashi City, Tokyo, 173-0032
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
- Recruiting
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, 245-8575
Argentina15 sites, 15 recruiting
- Recruiting
DOM Centro de Reumatología
Buenos Aires, Ciudad Autónoma de BuenosAires, C1111
- Recruiting
Aprillus Asistencia e Investigacion - Terrada 89
Buenos Aires, 1406
- Recruiting
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, C1121ADC
- Recruiting
Sanatorio Agote - Swiss Medical Group - PPDS
Buenos Aires, C1425EOE
- Recruiting
Centro Medico Arsema
Buenos Aires, C1427CCL
- Recruiting
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
- Recruiting
Sanatorio Allende S.A.-Hipolito Yrigoyen 384
Córdoba, X5000JHQ
- Recruiting
Framingham Centro Médico
La Plata, B1902COS
- Recruiting
Instituto CER S.A.
Quilmes, Buenos Aires, B1878DVB
- Recruiting
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes, Buenos Aires, B1878GEG
- Recruiting
MR Medicina Reumatologica
San Fernando, Buenos Aires, B1646GHP
- Recruiting
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, J5402DIL
- Recruiting
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000AXL
- Recruiting
Centro Medico Privado de Reumatologia - PPDS
San Miguel de Tucumán, Tucumán Province, T4000AXL
- Recruiting
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE
Italy8 sites, 8 recruiting
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
- Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126
- Recruiting
AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
- Recruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio, 00168
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 128
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, 33100
- Recruiting
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, 37126
Mexico8 sites, 8 recruiting
- Recruiting
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco, 44690
- Recruiting
Unidad de Atención Medica e Investigación en Salud
Mérida, 97000
- Recruiting
Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali, Estado de Baja California, 21200
- Recruiting
Consultorio de Reumatologia
México, 7760
- Recruiting
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, Mexico City, 11850
- Recruiting
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City, Mexico City, 6100
- Recruiting
Clinstile, S.A. de C.V.
Mexico City, 6700
- Recruiting
Mediadvance Clinical S.A.P.I. de C.V.
Parques de San Felipe, Chihuahua, 31203
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013
- Recruiting
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba, 14004
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Fundacio Hospital de l'Esperit Sant
Santa Coloma de Gramenet, Barcelona, 08923
- Recruiting
Hospital Quironsalud Infanta Luisa
Seville, 41010
- Recruiting
Hospital Universitario de Valme
Seville, 41014
Serbia6 sites, 6 recruiting
- Recruiting
Military Medical Academy
Belgrade, Belgrade, 11000
- Recruiting
Institute of Rheumatology - PPDS
Belgrade, 11000
- Recruiting
Klinika za Alergologiju i Imunologiju
Belgrade, 112108
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Recruiting
Clinical Centre of Vojvodina
Novi Sad, 21000
- Recruiting
Special Hospital For Rheumatic Diseases Novi Sad
Novi Sad, 21000
Chile5 sites, 5 recruiting
- Recruiting
Enroll SpA - Dr. Manuel Barros Borgono - PPDS
Providencia, 7500000
- Recruiting
BIOCINETIC Ltda
Santiago, 8350595
- Recruiting
Centro de especialidades médicas Vanguardia
Temuco, 4810345
- Recruiting
Clinical Research Chile SpA - PPDS
Valdivia, 5110683
- Recruiting
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña del Mar, Valparaiso, 2520000
France5 sites, 5 recruiting
- Recruiting
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, 33000
- Recruiting
CHU de Brest - Hôpital La Cavale Blanche
Brest, 29200
- Recruiting
GHRMSA - Hôpital Emile Muller
Mulhouse, 68100
- Recruiting
AP-HP - Hôpital Saint Antoine
Paris, 75012
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Germany4 sites, 4 recruiting
- Recruiting
Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
Bad Doberan, Mecklenburg-Vorpommern, 18209
- Recruiting
Rheumazentrum Greifswald
Greifswald Hansestadt, Mecklenburg-Vorpommern, 17493
- Recruiting
MVZ Rheuma
Hamburg, 20095
- Recruiting
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Greece4 sites, 4 recruiting
- Recruiting
Naval Hospital of Athens
Athens, Attica, 115 21
- Recruiting
Laiko General Hospital of Athens
Athens, Attica, 115 27
- Recruiting
University General Hospital of Larissa
Larissa, Larisa, 411 10
- Recruiting
Euromedica Kianous Stavros
Thessaloniki, 546 36
Hungary4 sites, 4 recruiting
- Recruiting
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
Budapest, 1097
- Recruiting
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar, 4032
- Recruiting
Bekes Varmegyei Kozponti Korhaz
Gyula, Bekes County, 5700
- Recruiting
Vasarhelyi Sarkanyfu Kft.
Hódmezovásárhely, Csongrád megye, 6800
Peru4 sites, 4 recruiting
- Recruiting
Hospital Militar Central Luis Arias Schereiber
Jesus Maria, 15001
- Recruiting
Medicentro Biociencias Peru S.R.L.
Pueblo Libre, Lima region, 1508
- Recruiting
Instituto de Ginecologia y Reproduccion - PPDS
Santiago de Surco, 33
- Recruiting
Clinica San Antonio S.A.C
Trujillo, La Libertad, 13008
Portugal4 sites, 4 recruiting
- Recruiting
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, Lisbon District, 1349-019
- Recruiting
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, Lisbon District, 1649-035
- Recruiting
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
Ponte de Lima, 4990-150
- Recruiting
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, 4434-502
Taiwan4 sites, 4 recruiting
- Recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
Taipei Medical University Hospital - PPDS
Taipei, 11031
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305
Brazil3 sites, 3 recruiting
- Recruiting
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, 80030-110
- Recruiting
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000
- Recruiting
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, 40150-150
New Zealand3 sites, 3 recruiting
- Recruiting
Optimal Clinical Trials Ltd - PPDS
Auckland, North Island, 1003
- Recruiting
Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
Hamilton, 3240
- Recruiting
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
Papatoetoe, 2025
United Kingdom3 sites, 3 recruiting
- Recruiting
Chapel Allerton Hospital - PPDS
Leeds, LS7 4SA
- Recruiting
Mile End Hospital - PPDS
London, E1 4DG
- Recruiting
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Croatia2 sites, 2 recruiting
- Recruiting
University Hospital of Split
Split, 21000
- Recruiting
Polyclinic Bonifarm
Zagreb, City of Zagreb, 10000
Israel2 sites, 2 recruiting
- Recruiting
Meir Medical Center
Kafr Saba, Central District, 4428164
- Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, 5262100
Australia1 site, 1 recruiting
- Recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Canada1 site, 1 recruiting
- Recruiting
Clinique de Rhumatologie Du Centre Du Quebec
Trois-Rivières, Quebec, G8Z 1Y2
Slovenia1 site, 1 recruiting
- Recruiting
University Clinical Centre Maribor
Maribor, 2000
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, 6591
About this study
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)
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
- Conditions
- Sjögren's Syndrome
- Being tested
- Dazodalibep
- Keywords
- Cluster of differentiation 40 (CD40), Dazodalibep, AMG 611
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DazodalibepDrug
Also called AMG 611
Dazodalibep will be given intravenously (IV).
| Study group | Role | What they receive |
|---|---|---|
| Dazodalibep | Experimental | 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. Receives: Drug: Dazodalibep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
Measured: Up to 152 weeks
Secondary outcomes (2)
Number of Participants with Anti-drug Antibodies (ADAs) During the Study
Measured: Up to 132 weeks
Plasma Concentration of Dazodalibep
Measured: Up to 132 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start25 Feb 2025
- Primary completion11 Dec 2029 (estimated)
- Study completion11 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 844 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747949
- Sponsor's protocol ID
- HZNP-DAZ-304
- Other IDs
- 20230050, 2024-517513-32-00
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06747949
- Acronym / sponsor ID
- HZNP-DAZ-304
- Conditions
- Sjögren's Syndrome
- Keywords
- Cluster of differentiation 40 (CD40), Dazodalibep, AMG 611
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 844 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 11 Dec 2029 (estimated)
- Study completion
- 11 Dec 2029 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dazodalibep | Experimental | Drug: DazodalibepParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DazodalibepAlso: AMG 611Dazodalibep will be given intravenously (IV). | Drug | Dazodalibep |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 152 weeks
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
2 secondary outcomes
Number of Participants with Anti-drug Antibodies (ADAs) During the Study
Time frame: Up to 132 weeks
Plasma Concentration of Dazodalibep
Time frame: Up to 132 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
174 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dazodalibep in people with Sjögren's Syndrome, run by Amgen at 174 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 174 sites in United States, Poland, Japan, Argentina, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 152 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.