A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

January 14, 2026 updated by: Amgen

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 Systemic Disease Activity

Primary Objective:

To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity.

Secondary Objectives:

  1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.
  2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Acquired from Horizon in 2024.

Study Type

Interventional

Enrollment (Actual)

651

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1111AAH
        • DOM Centro de Reumatología
      • Buenos Aires, Argentina, C1427CCL
        • Centro Médico Arsema
      • Buenos Aires, Argentina, C1406AGA
        • Aprillus Asistencia e Investigacion de Arcis Salud SRL
      • San Juan, Argentina, J5400DIL
        • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1425EOE
        • Sanatorio Agote - Swiss Medical Group - PPDS
      • La Plata, Buenos Aires, Argentina, B1900
        • Framingham Centro Medico
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes SRL
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Instituto CER S.A.
      • San Fernando, Buenos Aires, Argentina, B1646GHP
        • MR Medicina Reumatologica
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1128AAF
        • Expertia S.A- Mautalén Salud e Investigación
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1417
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
        • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1121ADC
        • Hospital General de Agudos Dr. José María Ramos Mejia
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5000JHGQ
        • Sanatorio Allende S.A
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucumán - PPDS
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Reumatológicas
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
        • Clínica Mayo de U.M.C.B. S.R.L
  • Australia
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • AES - AS - L2IP - Instituto de Pesquisas Clínicas LTDA Brasilia
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Centro Mineiro de Pesquisa - CMIP
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Centro de Estudos em Terapias Inovadoras
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Servicos Medicos SS
  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A 3X2
        • Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Clinical Research Chile SpA - PPDS
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520000
        • Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
    • Región de la Araucanía
      • Temuco, Región de la Araucanía, Chile, 4780000
        • Centro de especialidades médicas Vanguardia
    • Región-MetropolitanadeSantiago
      • Providencia, Región-MetropolitanadeSantiago, Chile, 7500587
        • Enroll SpA - Dr. Manuel Barros Borgono - PPDS
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8320000
        • Biocinetic Ltda
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Centre Osijek
      • Split, Croatia, 21000
        • University Hospital of Split-Spinciceva 1
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Clinical Center Zagreb - Oncology - Salata 7 - PPDS
      • Zagreb, City of Zagreb, Croatia, 10000
        • Polyclinic Bonifarm
  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux - Hôpital Saint-André
      • Brest, France, 29609
        • CHU de Brest - Hôpital La Cavale Blanche
      • Le Kremlin-Bicêtre, France, 94270
        • AP-HP - Hôpital Bicêtre
      • Strasbourg, France, 67200
        • Hôpitaux universitaires de Strasbourg
    • Haut-Rhin
      • Mulhouse, Haut-Rhin, France, 68100
        • Hôpital Emile Muller
  • Germany
      • Chemnitz, Germany, 09117
        • DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein
      • Hamburg, Germany, 20095
        • MVZ Rheuma
    • Mecklenburg-Vorpommern
      • Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
        • Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
      • Greifswald Hansestadt, Mecklenburg-Vorpommern, Germany, 17493
        • Rheumazentrum Greifswald
  • Greece
      • Thessaloniki, Greece, 546 36
        • Euromedica Kianous Stavros
    • Achaïa
      • Kato Sychena Patras, Achaïa, Greece, 264 43
        • Olympion General Clinic
    • Attica
      • Athens, Attica, Greece, 115 27
        • Laiko General Hospital of Athens
      • Athens, Attica, Greece, 115 21
        • Naval Hospital of Athens
    • Larisa
      • Larissa, Larisa, Greece, 411 10
        • University General Hospital of Larissa
  • Hungary
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
    • Bekes County
      • Gyula, Bekes County, Hungary, 5700
        • Bekes Varmegyei Kozponti Korhaz
    • Csongrád megye
      • Hódmezővásárhely, Csongrád megye, Hungary, 6800
        • Vasarhelyi Sarkanyfu Kft.
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
  • Israel
      • Ramat Gan, Israel, 5262100
        • The Chaim Sheba Medical Center - PPDS
    • Central District
      • Kfar Saba, Central District, Israel, 44281
        • Meir Medical Center
  • Italy
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42121
        • AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
    • Friuli Venezia Giulia
      • Udine, Friuli Venezia Giulia, Italy, 33100
        • Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino
    • Sicily
      • Catania, Sicily, Italy, 95121
        • AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Pisa, Tuscany, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata di Verona
  • Japan
    • Aiti
      • Nagoya, Aiti, Japan, 457-8511
        • Daido Clinic
      • Nagoya, Aiti, Japan, 455-0018
        • Chubu Rosai Hospital
      • Nagoya, Aiti, Japan, 457-0866
        • Japan Community Health Care Organization (JCHO) Chukyo Hospital
    • Hokkaidô
      • Sapporo, Hokkaidô, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Sapporo, Hokkaidô, Japan, 060-8648
        • Hokkaido University Hospital
    • Hukuoka
      • Kita Kyushu-shi, Hukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health, Japan
    • Hyôgo
      • Nishinomiya-Shi, Hyôgo, Japan, 663-8501
        • Hyogo Medical University Hospital
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
    • Ishikawa-ken
      • Kahoku, Ishikawa-ken, Japan, 920-0293
        • Kanazawa Medical University Hospital
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 245-8575
        • National Hospital Organization Yokohama Medical Center
    • Kyôto
      • Kyoto, Kyôto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Kyoto, Kyôto, Japan, 606-8507
        • Kyoto University Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Sasebo-Shi, Nagasaki, Japan, 857-1165
        • Sasebo Chuo Hospital
    • Okayama-ken
      • Kurashiki-Shi, Okayama-ken, Japan, 710-0824
        • Kurashiki Medical Clinic
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Saitama Medical University Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital
      • Chuo-Ku, Tokyo, Japan, 104-0044
        • St. Luke's International Hospital
      • Meguro-Ku, Tokyo, Japan, 152-8902
        • Tokyo Medical Center
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • tabashi City, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital
  • Mexico
      • León, Mexico, 37160
        • Centro de Investigacion Farmacologica Del Bajio Sc
      • Mitras Centro, Mexico, 64460
        • Hospital Universitario Dr. José Eleuterio González
      • Monterrey, Mexico, 64000
        • Accelerium, S. de R.L. de C.V. - PPDS
      • México, Mexico, 07760
        • Consultorio de Reumatologia
      • México, Mexico
        • Clinstile, S.A. de C.V.
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization - Clinic - OSMO - PPDS
    • Chihuahua
      • Parques de San Felipe, Chihuahua, Mexico, 31203
        • Mediadvance Clinical S.A.P.I. de C.V.
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25279
        • ONCOR - Centro de Infusion e Investigación Oncologia de Saltillo S.C
      • Torreón Centro, Coahuila, Mexico, 27000
        • CIMAB SA de CV
    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21200
        • Centro de Investigación en Artritis y Osteoporosis - PPDS
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Centro de Estudios de Investigacion Basica Y Clinica SC
      • Guadalajara, Jalisco, Mexico, ZC 44160
        • Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06100
        • Cryptex Investigación Clínica, S.A. de C.V.
      • San Miguel Chapultepec, Mexico City, Mexico, 11850
        • Centro de Investigación y Tratamiento Reumatológico S.C
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Unidad de Atención Médica e Investigación en Salud
  • New Zealand
      • Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials Trust
      • Auckland, New Zealand, 1003
        • Optimal Clinical Trials Ltd - PPDS
      • Hamilton, New Zealand, 3214
        • Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
  • Peru
      • Arequipa, Peru, 04013
        • Hogar Clínica San Juan de Dios - Arequipa
      • Lima, Peru, 11
        • Hospital Militar Central Luis Arias Schereiber
      • Lima, Peru, 15001
        • Clínica Internacional San Borja-Avenida Guardia Civil 385
      • Lima, Peru, Lima 33
        • Instituto de Ginecologia y Reproduccion - PPDS
      • Pueblo Libre, Peru, Lima 21
        • Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
    • La Libertad
      • Trujillo, La Libertad, Peru, 13008
        • Clinica San Antonio S.A.C
    • Lima region
      • San Juan de Lurigancho, Lima region, Peru, 15431
        • Clinica San Juan Bautista
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy
      • Bydgoszcz, Poland, 85-065
        • MICS Centrum Medyczne Bydgoszcz
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice - PPDS
      • Krakow, Poland, 30-363
        • Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
      • Krakow, Poland, 31-513
        • Centrum Medyczne PROMED- Olszanska 5G
      • Lodz, Poland, 91-363
        • FutureMeds - Lodz - PPDS
      • Poznan, Poland, 60-324
        • Twoja Przychodnia PCM
      • Warsaw, Poland, 02-677
        • ETG Warszawa - PPDS
      • Warsaw, Poland, 04-141
        • WIM-PIB, Centralny Szpital Kliniczny MON
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
      • Wroclaw, Poland, 53-034
        • Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
      • Wroclaw, Poland, 53-673
        • FutureMeds - Wroclaw - PPDS
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
        • Pratia Poznan - PPDS
      • Poznan, Greater Poland Voivodeship, Poland, 61-397
        • Prywatna Praktyka Lekarska Pawel Hrycaj
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • Med-Polonia Sp. z o.o.
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-149
        • Malopolskie Centrum Kliniczne
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
        • Centrum Medyczne Oporow
      • Wroclaw, Lower Silesian Voivodeship, Poland, 54-049
        • Dolnoslaski Szpital Specjalistyczny im. T. Marciniaka, Centrum Medycyny Ratunkowej
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-412
        • ETG Lublin - PPDS
      • Lublin, Lublin Voivodeship, Poland, 20-607
        • Reumed Sp. z o.o.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • MICS Centrum Medyczne Warszawa - MICS - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 02-665
        • Klinika Reuma Park sp . zoo Sp.k.
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • MTZ Clinical Research Powered by PRATIA - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 03-291
        • FutureMeds - Targowek - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 00-215
        • FutureMeds - Warszawa Centrum - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 02-637
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
      • Wołomin, Masovian Voivodeship, Poland, 05-200
        • K2J2 Medical Center
    • Pomeranian Voivodeship
      • Malbork, Pomeranian Voivodeship, Poland, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS
      • Vila Nova de Gaia, Portugal, 4434-502
        • ULS de Gaia/Espinho, EPE - Unidade I
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1349-019
        • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
    • Viana do Castelo District
      • Ponte de Lima, Viana do Castelo District, Portugal, 4990-041
        • Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC -62 Calle Jose Marti
  • Serbia
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11000
        • Institute of Rheumatology - PPDS
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia - Pasterova 2 - PPDS
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac
      • Novi Sad, Serbia, 21000
        • Special Hospital For Rheumatic Diseases Novi Sad
      • Novi Sad, Serbia, 21000
        • Clinical Centre of Vojvodina
  • South Korea
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul ST. Mary's Hospital
  • Spain
      • Bilbao, Spain, 48013
        • Hospital Universitario de Basurto
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28032
        • Hospital Universitario Infanta Leonor
      • Santa Coloma de Gramenet(Barcelona), Spain, 08923
        • Fundacio Hospital de l'Esperit Sant
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Seville, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Seville, Spain, 41010
        • Hospital Quironsalud Infanta Luisa
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia - PPDS
    • Málaga
      • Málaga, Málaga, Spain, 29009
        • Hospital Regional Universitario de Malaga - Hospital Civil
  • Taiwan
      • Gui Shan Qu, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University - Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 11031
        • Taipei Medical University Hospital - PPDS
  • United Kingdom
      • Leeds, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital - PPDS
      • London, United Kingdom, EC1M 6BQ
        • William Harvey Research Institute - PPDS
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Portsmouth, United Kingdom, P06 3LY
        • Queen Alexandra Hospital
  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Arizona Arthritis & Rheumatology Associates - Avondale
      • Chandler, Arizona, United States, 85225-2915
        • Arizona Research Clinic PLLC
      • Flagstaff, Arizona, United States, 86001-6299
        • Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
      • Gilbert, Arizona, United States, 85297-7338
        • Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
      • Glendale, Arizona, United States, 85306-9800
        • Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
      • Tucson, Arizona, United States, 85704-1140
        • Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
    • California
      • La Jolla, California, United States, 92037-1337
        • UCSD Altman Clinical and Translational Research Institute Building
      • Upland, California, United States, 91786-4951
        • Inland Rheumatology Clinical Trials Incorporated
    • Colorado
      • Fort Collins, Colorado, United States, 80528-3404
        • Tekton Research, LLC - 2121 E Harmony Rd - PPDS
    • Florida
      • Bradenton, Florida, United States, 34205-1704
        • Bradenton Research Center Inc
      • Clearwater, Florida, United States, 33765-2616
        • Clinical Research of West Florida Inc - Clearwater
      • Miami, Florida, United States, 33136-1011
        • University of Miami - Leonard M. Miller School of Medicine
      • New Port Richey, Florida, United States, 34652-4020
        • Suncoast Clinical Research - ATLAS - New Port Richey - PPDS
      • Ormond Beach, Florida, United States, 32174-1140
        • Millennium Research
      • Tamarac, Florida, United States, 33321-2956
        • West Broward Rheumatology Associates, Inc.
      • Tampa, Florida, United States, 33614-7101
        • BayCare Medical Group
    • Georgia
      • Augusta, Georgia, United States, 30912-0004
        • Augusta University Medical Center-Augusta-1120 15th St
    • Illinois
      • Rockford, Illinois, United States, 61114-4937
        • OrthoIllinois, LTD
    • Kansas
      • Kansas City, Kansas, United States, 66160-0001
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2621
        • Massachusetts General Hospital
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Clinical Research Institute of Michigan, LLC-St. Claire Shores
    • Missouri
      • Kansas City, Missouri, United States, 64151-5100
        • Kansas City Physician Partners-8350 N Saint Clair Ave
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043-4509
        • Arthritis, Rheumatic & Bone Disease Associates - P
    • New York
      • Brooklyn, New York, United States, 11201-5501
        • NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
      • Durham, North Carolina, United States, 27710-0001
        • Duke Early Phase Clinical Research Unit - PPDS
      • Salisbury, North Carolina, United States, 28144
        • Onsite Clinical Solutions, LLC - Salisbury
    • Ohio
      • Miamisburg, Ohio, United States, 45342
        • Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
      • Toledo, Ohio, United States, 43614-2595
        • University of Toledo Medical Center
      • Vandalia, Ohio, United States, 45377-9474
        • STAT Research-600 Aviator Ct
    • South Carolina
      • Summerville, South Carolina, United States, 29486-7887
        • Low Country Rheumatology PA-Summerville
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37128
        • Murfreesboro Medical Clinic Westlawn
    • Texas
      • Amarillo, Texas, United States, 79124-1601
        • Amarillo Center for Clinical Research
      • Austin, Texas, United States, 78745-1470
        • Tekton Research, LLC - W Gate Blvd - Austin - PPDS
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Management-Baytown
      • Grapevine, Texas, United States, 76051-3143
        • Precision Comprehensive Clinical Research Solutions
      • Houston, Texas, United States, 77054-2853
        • Prolato Clinical Research Center
      • Katy, Texas, United States, 77450
        • R & H Clinical Research-777 S Fry Rd
      • McAllen, Texas, United States, 78501
        • Valley Arthritis Center
      • San Antonio, Texas, United States, 78229-3901
        • University of Texas - San Antonio - Health Science Center - PPDS
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Migraine and COPD - PPDS
    • Utah
      • West Valley City, Utah, United States, 84119
        • Metrodora Institute
    • Washington
      • Bellevue, Washington, United States, 98004-3016
        • Overlake Arthritis & Osteoporosis Center
      • Bothell, Washington, United States, 98021
        • Western Washington Medical Group, Bothell - Rheumatology
    • West Virginia
      • Beckley, West Virginia, United States, 25801-2805
        • Rheumatology and Pulmonary Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
  • Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.
  • Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

Key Exclusion Criteria:

  • Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  • Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
  • Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that 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 hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.
  • Active TB or untreated (per local guidelines) latent TB
  • Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
  • Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
  • Last administration of experimental or investigational biologic or oral agents < 6 months prior to screening.
  • Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dazodalibep Dose 1
Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
Drug: Dazodalibep
IV infusion
Other Names:
  • VIB 4920
  • MEDI 4920
Experimental: Dazodalibep Dose 2
Participants will be administered dose 2 of dazodalibep by IV infusion.
Drug: Dazodalibep
IV infusion
Other Names:
  • VIB 4920
  • MEDI 4920
Placebo Comparator: Placebo
Participants will be administered placebo by IV infusion.
Drug: Placebo
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
Time Frame: At Week 48
At Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving ESSDAI response
Time Frame: At Week 48
At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score
Time Frame: At Week 48
At Week 48
Change from baseline in ESSPRI dryness domain score
Time Frame: At Week 48
At Week 48
Change from baseline in tender and swollen joint counts
Time Frame: At Week 48
At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)
Time Frame: At Week 48
At Week 48
Change from baseline in ESSDAI score
Time Frame: Week 12 and Week 24
Week 12 and Week 24
Change from baseline in DASPRI total score
Time Frame: At Week 48
At Week 48
Change from baseline in ESSPRI total score
Time Frame: At Week 48
At Week 48
Change from baseline in total stimulated salivary flow
Time Frame: At Week 48
At Week 48
Number of participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline (Day 1) to Week 56
Baseline (Day 1) to Week 56
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: Up to Week 56
Up to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)
Time Frame: Up to Week 56
Up to Week 56
Change from baseline in DASPRI dryness domain score
Time Frame: At Week 48
At Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

August 19, 2026

Study Completion (Estimated)

August 19, 2026

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZNP-DAZ-301
  • 2023-503904-10-00 (Registry Identifier: EU Clinical Trial Information System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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