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
Status: Active_not_recruiting
Location: See all (224) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale
Arizona Research Clinic PLLC
Chandler
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
Flagstaff
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
Gilbert
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
Glendale
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
Tucson
California
UCSD Altman Clinical and Translational Research Institute Building
La Jolla
Inland Rheumatology Clinical Trials Incorporated
Upland
Colorado
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
Fort Collins
Florida
Bradenton Research Center Inc
Bradenton
Clinical Research of West Florida Inc - Clearwater
Clearwater
University of Miami - Leonard M. Miller School of Medicine
Miami
Suncoast Clinical Research - ATLAS - New Port Richey - PPDS
New Port Richey
Millennium Research
Ormond Beach
West Broward Rheumatology Associates, Inc.
Tamarac
BayCare Medical Group
Tampa
Georgia
Augusta University Medical Center-Augusta-1120 15th St
Augusta
Illinois
OrthoIllinois, LTD
Rockford
Kansas
University of Kansas Medical Center
Kansas City
Massachusetts
Massachusetts General Hospital
Boston
Michigan
Clinical Research Institute of Michigan, LLC-St. Claire Shores
Saint Clair Shores
Missouri
Kansas City Physician Partners-8350 N Saint Clair Ave
Kansas City
North Carolina
Arthritis and Osteoporosis Consultants of The Carolinas
Charlotte
Duke Early Phase Clinical Research Unit - PPDS
Durham
Onsite Clinical Solutions, LLC - Salisbury
Salisbury
New Jersey
Arthritis, Rheumatic & Bone Disease Associates - P
Voorhees Township
New York
NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn
Ohio
Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
Miamisburg
University of Toledo Medical Center
Toledo
STAT Research-600 Aviator Ct
Vandalia
South Carolina
Low Country Rheumatology PA-Summerville
Summerville
Tennessee
Murfreesboro Medical Clinic Westlawn
Murfreesboro
Texas
Amarillo Center For Clinical Research
Amarillo
Tekton Research, LLC - W Gate Blvd - Austin - PPDS
Austin
Accurate Clinical Management-Baytown
Baytown
Precision Comprehensive Clinical Research Solutions
Grapevine
Prolato Clinical Research Center
Houston
R & H Clinical Research-777 S Fry Rd
Katy
Valley Arthritis Center
Mcallen
University of Texas - San Antonio - Health Science Center - PPDS
San Antonio
DM Clinical Research - Migraine and COPD - PPDS
Tomball
Utah
Metrodora Institute
West Valley City
Washington
Overlake Arthritis & Osteoporosis Center
Bellevue
Western Washington Medical Group, Bothell - Rheumatology
Bothell
West Virginia
Rheumatology and Pulmonary Clinic
Beckley
Other Locations
Argentina
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Buenos Aires
Centro Medico Arsema
Buenos Aires
Centro Privado de Medicina Familiar
Buenos Aires
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Buenos Aires
DOM Centro de Reumatología
Buenos Aires
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires
Sanatorio Agote - Swiss Medical Group - PPDS
Ciudad Autónoma De Buenos Aires
Sanatorio Guemes
Ciudad Autónoma De Buenos Aires
Sanatorio Allende S.A
Córdoba
Framingham Centro Médico
La Plata
Instituto CER S.A.
Quilmes
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes
MR Medicina Reumatologica
San Fernando
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel De Tucumán
Centro de Investigaciones Reumatológicas
San Miguel De Tucumán
Clínica Mayo de U.M.C.B. S.R.L
San Miguel De Tucumán
Australia
The Queen Elizabeth Hospital
Woodville South
Belgium
UZ Gent
Ghent
UZ Leuven
Leuven
Brazil
Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
Belo Horizonte
AES - AS - L2IP - Instituto de Pesquisas Clínicas LTDA Brasilia
Brasília
Centro de Estudos em Terapias Inovadoras
Curitiba
Centro Mineiro de Pesquisa - CMiP
Juiz De Fora
LMK Servicos Medicos SS
Porto Alegre
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador
Canada
Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille
Trois-rivières
Chile
Enroll SpA - Dr. Manuel Barros Borgono - PPDS
Providencia
BIOCINETIC Ltda
Santiago
Centro de especialidades médicas Vanguardia
Temuco
Clinical Research Chile SpA - PPDS
Valdivia
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña Del Mar
Croatia
Clinical Hospital Centre Osijek
Osijek
University Hospital of Split-Spinciceva 1
Split
Clinical Center Zagreb - Oncology - Salata 7 - PPDS
Zagreb
Polyclinic Bonifarm
Zagreb
France
CHU de Bordeaux - Hôpital Saint-André
Bordeaux
CHU de Brest - Hôpital La Cavale Blanche
Brest
AP-HP - Hôpital Bicêtre
Le Kremlin-bicêtre
Hopital Emile Muller
Mulhouse
CHU de Saint-Etienne - Hôpital Nord
Saint-priest-en-jarez
Hôpitaux Universitaires de Strasbourg
Strasbourg
Germany
Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
Bad Doberan
DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein
Chemnitz
Rheumazentrum Greifswald
Greifswald Hansestadt
MVZ Rheuma
Hamburg
University Clinic Heidelberg
Heidelberg
Greece
Laiko General Hospital of Athens
Athens
Naval Hospital of Athens
Athens
Olympion General Clinic
Kato Sychena Patras
University General Hospital of Larissa
Larissa
Euromedica Kianous Stavros
Thessaloniki
General Hospital ''Asklepieio Voulas''
Voula
Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
Budapest
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen
Bekes Varmegyei Kozponti Korhaz
Gyula
Vasarhelyi Sarkanyfu Kft.
Hódmezővásárhely
Israel
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem
Meir Medical Center
Kfar Saba
The Chaim Sheba Medical Center - PPDS
Ramat Gan
Italy
AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco
Catania
San Paolo Hospital Civitavecchia
Civitavecchia Rm
Azienda Ospedaliera Universitaria Careggi
Florence
ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa
AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome
Fondazione Policlinico Universitario Campus Bio-Medico
Rome
A.O.U. Città della Salute e della Scienza di Torino
Turin
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona
Japan
Nippon Medical School Hospital
Bunkyo-ku
St. Luke's International Hospital
Chuo-ku
Hamamatsu University Hospital
Hamamatsu
Saitama Medical University Hospital
Iruma-gun
Kanazawa Medical University Hospital
Kahoku
Kanazawa University Hospital
Kanazawa
Hospital of the University of Occupational and Environmental Health, Japan
Kita Kyushu-shi
Kurashiki Medical Clinic
Kurashiki-shi
Kyoto University Hospital
Kyoto
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
Tokyo Medical Center
Meguro-ku
Nagasaki University Hospital
Nagasaki
Chubu Rosai Hospital
Nagoya
Daido Clinic
Nagoya
Japan Community Health Care Organization (JCHO) Chukyo Hospital
Nagoya
Hyogo Medical University Hospital
Nishinomiya-shi
Hokkaido University Hospital
Sapporo
Sapporo Medical University Hospital
Sapporo
Sasebo Chuo Hospital
Sasebo-shi
Keio University Hospital
Shinjuku-ku
Nihon University Itabashi Hospital
Tabashi City
University of Tsukuba Hospital
Tsukuba
National Hospital Organization Yokohama Medical Center
Yokohama
Mexico
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
Guadalajara
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara
Centro de Investigacion Farmacologica Del Bajio Sc
León
Unidad de Atencion Medica e Investigacion en Salud
Mérida
Centro de Investigación en Artritis y Osteoporosis - PPDS
Mexicali
Clinstile, S.A. de C.V.
México
Consultorio de Reumatologia
México
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Mitras Centro
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey
Oaxaca Site Management Organization - Clinic - OSMO - PPDS
Oaxaca City
Mediadvance Clinical S.A.P.I. de C.V.
Parques De San Felipe
ONCOR - Centro de Infusion e Investigación Oncologia de Saltillo S.C
Saltillo
Centro de Investigación y Tratamiento Reumatológico S.C
San Miguel Chapultepec
CIMAB SA de CV
Torreón Centro
New Zealand
Aotearoa Clinical Trials Trust
Auckland
Optimal Clinical Trials Ltd - PPDS
Auckland
Waikato Hospital
Hamilton
Peru
Hogar Clinica San Juan de Dios - Arequipa
Arequipa
Clínica Internacional San Borja-Avenida Guardia Civil 385
Lima
Hospital Militar Central Luis Arias Schereiber
Lima
Instituto de Ginecologia y Reproduccion - PPDS
Lima
Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
Pueblo Libre
Clinica San Juan Bautista
San Juan De Lurigancho
Clinica San Antonio S.A.C
Trujillo
Poland
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz
Centrum Medyczne Pratia Katowice - PPDS
Katowice
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow
Centrum Medyczne PROMED- Olszanska 5G
Krakow
Malopolskie Centrum Kliniczne
Krakow
FutureMeds - Lodz - PPDS
Lodz
ETG Lublin - PPDS
Lublin
Reumed Sp. z o.o.
Lublin
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
Malbork
Med-Polonia Sp. z o.o.
Poznan
Pratia Poznan - PPDS
Poznan
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan
Twoja Przychodnia PCM
Poznan
ETG Warszawa - PPDS
Warsaw
FutureMeds - Targowek - PPDS
Warsaw
FutureMeds - Warszawa Centrum - PPDS
Warsaw
Klinika Reuma Park sp . zoo Sp.k.
Warsaw
MICS Centrum Medyczne Warszawa - MICS - PPDS
Warsaw
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw
WIM-PIB, Centralny Szpital Kliniczny MON
Warsaw
K2J2 Medical Center
Wołomin
Centrum Medyczne Oporow
Wroclaw
Dolnoslaski Szpital Specjalistyczny im. T. Marciniaka, Centrum Medycyny Ratunkowej
Wroclaw
FutureMeds - Wroclaw - PPDS
Wroclaw
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
Wroclaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
Wroclaw
Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS
Lisbon
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
Ponte De Lima
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova De Gaia
Puerto Rico
GCM Medical Group, PSC -62 Calle Jose Marti
San Juan
Republic of Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Serbia
Institute of Rheumatology - PPDS
Belgrade
Military Medical Academy
Belgrade
University Clinical Center of Serbia - Pasterova 2 - PPDS
Belgrade
University Clinical Center Kragujevac
Kragujevac
Clinical Centre of Vojvodina
Novi Sad
Special Hospital For Rheumatic Diseases Novi Sad
Novi Sad
Spain
Hospital Universitario de Basurto
Bilbao
C.H. Regional Reina Sofia - PPDS
Córdoba
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Regional Universitario de Malaga - Hospital Civil
Málaga
Fundacio Hospital de l'Esperit Sant
Santa Coloma De Gramenet(barcelona)
Hospital Universitario de Canarias
Santa Cruz De Tenerife
Hospital Nuestra Señora de Valme
Seville
Hospital Quironsalud Infanta Luisa
Seville
Hospital Universitario Araba - Txagorritxu
Vitoria-gasteiz
Taiwan
Chang Gung Memorial Hospital, Linkou
Gui Shan Qu
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
Taipei Medical University Hospital - PPDS
Taipei
United Kingdom
Chapel Allerton Hospital - PPDS
Leeds
William Harvey Research Institute - PPDS
London
Royal Victoria Infirmary
Newcastle Upon Tyne
Queen Alexandra Hospital
Portsmouth
Time Frame
Start Date: 2025-02-25
Completion Date: 2026-08-19
Participants
Target number of participants: 651
Treatments
Experimental: Dazodalibep Dose 1
Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
Experimental: Dazodalibep Dose 2
Participants will be administered dose 2 of dazodalibep by IV infusion.
Placebo_comparator: Placebo
Participants will be administered placebo by IV infusion.
Related Therapeutic Areas
Sponsors
Leads: Amgen