A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

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 Symptom State (HZNP-DAZ-303)

Primary Objective:

To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state

Secondary Objectives:

1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS.
2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS
3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

Study Overview

• Status: Active, not recruiting
• Conditions: Sjögren's Syndrome (SS)
• Intervention / Treatment: Drug: Placebo; Drug: Dazodalibep

Detailed Description

Acquired from Horizon in 2024.

• Study Type: Interventional
• Enrollment (Actual): 434
• Phase: Phase 3

Contacts and Locations

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
  • Córdoba, Argentina, X5000JHQ
    • Sanatorio Allende S.A
  • 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
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1425EUG
      • Sanatorio Güemes
    • 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.
  • Ciudad Autónoma de BuenosAires
    • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1121ADC
      • Hospital General de Agudos Dr. José María Ramos Mejia
    • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426
      • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
  • 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
  • Ghent, Belgium, 9000
    • UZ Gent
• Brazil
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150-150
      • SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
  • 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, 5090000
      • 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-MetropolitanadeSantiago
    • Peñalolén, Región-MetropolitanadeSantiago, Chile, 7910000
      • Biocinetic Ltda
    • Santiago, Región-MetropolitanadeSantiago, Chile
      • Enroll SpA - Dr. Manuel Barros Borgono - PPDS
• 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 Hospital Sveti Duh
    • 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
  • Mulhouse, France, 68100
    • Hopital Emile Muller
  • Paris, France, 75571
    • AP-HP - Hôpital Saint Antoine
  • Strasbourg, France, 67200
    • Hôpitaux Universitaires de Strasbourg
• Germany
  • Chemnitz, Germany, 09117
    • DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein
  • Hamburg, Germany, 20095
    • MVZ Rheuma
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • University Clinic Heidelberg
  • 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
  • Attica
    • Athens, Attica, Greece, 115 27
      • Laiko General 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.
• Italy
  • Catania, Italy, 95121
    • AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
  • 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 Cà Granda Ospedale Maggiore Policlinico
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • Azienda Ospedaliero Universitaria Maggiore della Carità
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Azienda Ospedaliera Universitaria Careggi
  • 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
    • 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
  • Mitras Centro, Mexico, 64460
    • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • 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.
  • Chihuahua
    • Parques de San Felipe, Chihuahua, Mexico, 31203
      • Mediadvance Clinical S.A.P.I. de C.V.
  • Coahuila
    • 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
    • Americana, Jalisco, Mexico, 44160
      • Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
  • Mexico City
    • Mexico City, Mexico City, Mexico, 6100
      • Cryptex Investigación Clínica, S.A. de C.V.
    • San Miguel Chapultepec, Mexico City, Mexico, 11850
      • Centro de Investigación y Tratamiento Reumatológico S.C
  • Oaxaca
    • Centro, Oaxaca, Mexico, 68000
      • Oaxaca Site Management Organization - Clinic - OSMO - PPDS
• New Zealand
  • Auckland, New Zealand, 2025
    • Aotearoa Clinical Trials Trust
  • Hamilton, New Zealand, 3214
    • Waikato Hospital
  • North Island
    • Auckland, North Island, New Zealand, 1003
      • Optimal Clinical Trials Ltd - PPDS
• 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, 15046
    • Instituto Peruano del Hueso y la Articulacion S.A.C.
  • 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
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice - PPDS
  • Krakow, Poland, 30-363
    • Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
  • Lodz, Poland, 91-363
    • FutureMeds - Lodz - PPDS
  • Poznan, Poland, 60-324
    • Twoja Przychodnia PCM
  • 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
  • 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, 50-088
      • FutureMeds - Wroclaw - PPDS
  • 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, 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
  • Lisbon, Portugal, 1300-344
    • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
  • Ponte de Lima, Portugal, 4990-041
    • Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
  • Vila Nova de Gaia, Portugal, 4434-502
    • ULS de Gaia/Espinho, EPE - Unidade I
• 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
• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana-Vodnikova cesta 62
  • Maribor, Slovenia, 2000
    • University Clinical Centre Maribor
• South Korea
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul ST. Mary's Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario A Coruña
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • San Cristóbal de La Laguna, Spain, 38330
    • Hospital Universitario de Canarias
  • Santa Coloma de Gramenet(Barcelona), Spain, 08923
    • Fundacio Hospital de l'Esperit Sant
  • Seville, Spain, 41014
    • Hospital Nuestra Senora de Valme
  • Seville, Spain, 41010
    • Hospital Quironsalud Infanta Luisa
  • Córdoba
    • Córdoba, Córdoba, Spain, 14004
      • C.H. Regional Reina Sofia - PPDS
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario de Basurto
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01009
      • Hospital Universitario Araba - Txagorritxu
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital - PPDS
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou
• United Kingdom
  • Leeds, United Kingdom, LS7 4SA
    • Chapel Allerton Hospital - PPDS
  • London, United Kingdom, EC1M 6BQ
    • William Harvey Research Institute - PPDS
• 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
    • Covina, California, United States, 91723
      • Medvin Clinical Research - Covina
    • 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
    • Whittier, California, United States, 90602
      • Medvin Clinical Research
  • Colorado
    • Fort Collins, Colorado, United States, 80528-3400
      • 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
    • Tamarac, Florida, United States, 33321-2956
      • West Broward Rheumatology Associates, Inc.
    • Tampa, Florida, United States, 33614-7101
      • BayCare Medical Group Primary Care and Rheumatology - Tampa
  • Kansas
    • Kansas City, Kansas, United States, 66160-8500
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts Medical Center - Rheumatology Research Office - PPDS
  • 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 Mexico
    • Albuquerque, New Mexico, United States, 87102-1710
      • Albuquerque Center for Rheumatology
  • 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, 28207-1100
      • Arthritis and Osteoporosis Consultants of The Carolinas
    • 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, 45342-3585
      • 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
      • 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
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Management-Baytown
    • Grapevine, Texas, United States, 76051-3143
      • Precision Comprehensive Clinical Research Solutions
    • Katy, Texas, United States, 77450-2297
      • R & H Clinical Research-777 S Fry Rd
    • Katy, Texas, United States, 77450
      • Texas Arthritis & Rheumatology Associates
    • McAllen, Texas, United States, 78501
      • Valley Arthritis Center
    • San Antonio, Texas, United States, 78229-3901
      • University of Texas - San Antonio - Health Science Center - PPDS
    • The Woodlands, Texas, United States, 77382
      • Advanced Rheumatology of Houston - The Woodlands
    • Tomball, Texas, United States, 77375
      • DM Clinical Research - Migraine and COPD - PPDS
  • Washington
    • Bothell, Washington, United States, 98021-4418
      • Western Washington Medical Group
  • West Virginia
    • Beckley, West Virginia, United States, 25801-2805
      • Rheumatology and Pulmonary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
2. Have an ESSPRI score of ≥ 5 at screening.
3. Have an ESSDAI score of < 5 at screening.
4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
5. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.

7. Meets all of the following tuberculosis (TB) criteria:

   1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
   2. No signs or symptoms suggestive of active TB from medical history or physical examination.
   3. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
   4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
   5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).

Key Exclusion Criteria:

1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.

3. Active malignancy or history of malignancy within the last 5 years, except as follows:

   1. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR
   2. Cutaneous basal cell carcinoma following presumed curative therapy.
4. Individuals who are pregnant or lactating or planning to become pregnant during the study.
5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
6. Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, 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.
7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
8. Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization.

9. Individuals with:

   1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
   2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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: MEDI4920; VIB 4920
Experimental: Dazodalibep Dose 2; Participants will be administered dose 2 of dazodalibep by IV infusion.	Drug: Dazodalibep; IV infusion; Other Names: MEDI4920; VIB 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 ESSPRI score	At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score	At week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in total stimulated salivary flow	At Week 48
Number of participants With Treatment Emergent Adverse Events (TEAEs)	Baseline (Day 1) to Week 56
Proportion of participants achieving meaningful improvement in DASPRI	At Week 48
Proportion of participants achieving ESSPRI [1.5] response	At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a)	At Week 48
Change from baseline in DASPRI Dryness	At Week 48
Change from baseline in ESSPRI Dryness	At Week 48
Change from baseline in DASPRI Pain	At Week 48
Change from baseline in ESSPRI Pain	At Week 48
Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score	At Week 48
Change from baseline in DASPRI total score	At week 12 and week 24
Change from baseline in ESSPRI total score	At week 12, Week 24
Change from baseline in DASPRI Fatigue	At Week 48
Change from baseline in ESSPRI fatigue domain score	At Week 48
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)	Baseline (Day 1) to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)	Baseline (Day 1) to Week 56

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): December 17, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI); European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI); European Alliance of Associations for Rheumatology (EULAR)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome
• Other Study ID Numbers: HZNP-DAZ-303

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