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COMPLETED
NCT06104124
PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

651

Start Date

2024-01-24

Completion Date

2026-08-17

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Dazodalibep

IV infusion

DRUG

Placebo

IV infusion

Locations (206)

Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States

Arizona Research Clinic PLLC

Chandler, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln

Flagstaff, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St

Gilbert, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln

Glendale, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd

Tucson, Arizona, United States

UCSD Altman Clinical and Translational Research Institute Building

La Jolla, California, United States

Inland Rheumatology Clinical Trials Incorporated

Upland, California, United States

Tekton Research, LLC - 2121 E Harmony Rd - PPDS

Fort Collins, Colorado, United States

Bradenton Research Center Inc

Bradenton, Florida, United States

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, United States

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, United States

BayCare Medical Group

Tampa, Florida, United States

Augusta University Medical Center-Augusta-1120 15th St

Augusta, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital (MGH) - Rheumatology Associates

Boston, Massachusetts, United States

Clinical Research Institute of Michigan, LLC-St. Claire Shores

Saint Clair Shores, Michigan, United States

Kansas City Physician Partners-8350 N Saint Clair Ave

Kansas City, Missouri, United States

Arthritis, Rheumatic & Bone Disease Associates - Voorhees

Voorhees Township, New Jersey, United States

NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center

Brooklyn, New York, United States

Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 801 E Morehead St

Charlotte, North Carolina, United States

Duke Early Phase Clinical Research Unit - PPDS

Durham, North Carolina, United States

Onsite Clinical Solutions, LLC - Salisbury

Salisbury, North Carolina, United States

University of Toledo Medical Center

Toledo, Ohio, United States

STAT Research-600 Aviator Ct

Vandalia, Ohio, United States

Low Country Rheumatology PA-Summerville

Summerville, South Carolina, United States

Murfreesboro Medical Clinic Westlawn

Murfreesboro, Tennessee, United States

Amarillo Center For Clinical Research

Amarillo, Texas, United States

Tekton Research, LLC - W Gate Blvd - Austin - PPDS

Austin, Texas, United States

Accurate Clinical Management-Baytown

Baytown, Texas, United States

Cedar Health Research - Arlington - PPDS

Euless, Texas, United States

R & H Clinical Research - Katy - 1531 Westborough Dr

Katy, Texas, United States

Valley Arthritis Center

McAllen, Texas, United States

University of Texas - San Antonio - Health Science Center - PPDS

San Antonio, Texas, United States

DM Clinical Research - Migraine and COPD - PPDS

Tomball, Texas, United States

Overlake Arthritis & Osteoporosis Center

Bellevue, Washington, United States

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, United States

Sanatorio Agote - Swiss Medical Group - PPDS

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Framingham Centro Médico

La Plata, Buenos Aires, Argentina

Instituto CER S.A.

Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires, Argentina

MR Medicina Reumatologica

San Fernando, Buenos Aires, Argentina

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Sanatorio Allende S.A

Córdoba, Córdoba Province, Argentina

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

DOM Centro de Reumatología

Buenos Aires, Argentina

Aprillus Asistencia e Investigacion de Arcis Salud SRL

Buenos Aires, Argentina

Centro Medico Arsema

Buenos Aires, Argentina

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

San Juan, Argentina

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

Salvador, Estado de Bahia, Brazil

AES - AS - L2IP - Instituto de Pesquisas Clínicas LTDA Brasilia

Brasília, Federal District, Brazil

Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS

Belo Horizonte, Minas Gerais, Brazil

Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná, Brazil

LMK Servicos Medicos SS

Porto Alegre, Rio Grande do Sul, Brazil

Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille

Trois-Rivières, Quebec, Canada

Centro de especialidades médicas Vanguardia

Temuco, Araucania, Chile

Clinical Research Chile SpA - PPDS

Valdivia, Los Ríos Region, Chile

Enroll SpA - Dr. Manuel Barros Borgono - PPDS

Providencia, Región-MetropolitanadeSantiago, Chile

BIOCINETIC Ltda

Santiago, Región-MetropolitanadeSantiago, Chile

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Valparaiso, Chile

Clinical Center Zagreb - Oncology - Salata 7 - PPDS

Zagreb, City of Zagreb, Croatia

Polyclinic Bonifarm

Zagreb, City of Zagreb, Croatia

Clinical Hospital Centre Osijek

Osijek, Croatia

University Hospital of Split-Spinciceva 1

Split, Croatia

Hopital Emile Muller

Mulhouse, Haut-Rhin, France

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, France

CHU de Brest - Hôpital La Cavale Blanche

Brest, France

AP-HP - Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan

Bad Doberan, Mecklenburg-Vorpommern, Germany

Rheumazentrum Greifswald

Greifswald Hansestadt, Mecklenburg-Vorpommern, Germany

DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein

Chemnitz, Germany

MVZ Rheuma

Hamburg, Germany

Olympion General Clinic

Kato Sychena Patras, Achaïa, Greece

Naval Hospital of Athens

Athens, Attica, Greece

Laiko General Hospital of Athens

Athens, Attica, Greece

University General Hospital of Larissa

Larissa, Larisa, Greece

Euromedica Kianous Stavros

Thessaloniki, Greece

Bekes Varmegyei Kozponti Korhaz

Gyula, Bekes County, Hungary

Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, Csongrád megye, Hungary

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar, Hungary

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7

Budapest, Hungary

Meir Medical Center

Kfar Saba, Central District, Israel

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Israel

AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, Italy

Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia

Udine, Friuli Venezia Giulia, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

A.O.U. Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco

Catania, Sicily, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

And 106 more locations on ClinicalTrials.gov