Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

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

2026-08-19

Last Updated

2026-01-16

Healthy Volunteers

Conditions

Sjogren's Syndrome

Interventions

DRUG

Dazodalibep

IV infusion

DRUG

Placebo

IV infusion

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.

Locations (216)

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

University of Miami - Leonard M. Miller School of Medicine

Miami, Florida, United States

Suncoast Clinical Research - ATLAS - New Port Richey - PPDS

New Port Richey, Florida, United States

Millennium Research

Ormond Beach, 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

OrthoIllinois, LTD

Rockford, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

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 - P

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 - 1918 Randolph Rd

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

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg

Miamisburg, Ohio, 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

Precision Comprehensive Clinical Research Solutions

Grapevine, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

R & H Clinical Research-777 S Fry Rd

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

Metrodora Institute

West Valley City, Utah, United States

Overlake Arthritis & Osteoporosis Center

Bellevue, Washington, United States

Western Washington Medical Group, Bothell - Rheumatology

Bothell, 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 Mineiro de Pesquisa - CMiP

Juiz de Fora, 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

Clinical Research Chile SpA - PPDS

Valdivia, Los Ríos Region, Chile

Centro de especialidades médicas Vanguardia

Temuco, Región de la Araucanía, Chile

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Región de Valparaíso, Chile

Enroll SpA - Dr. Manuel Barros Borgono - PPDS

Providencia, Región-MetropolitanadeSantiago, Chile

BIOCINETIC Ltda

Santiago, Región-MetropolitanadeSantiago, 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

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany, Italy

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, Italy

Chubu Rosai Hospital

Nagoya, Aiti, Japan

Japan Community Health Care Organization (JCHO) Chukyo Hospital

Nagoya, Aiti, Japan

Daido Clinic

Nagoya, Aiti, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaidô, Japan

Hokkaido University Hospital

Sapporo, Hokkaidô, Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kita Kyushu-shi, Hukuoka, Japan

Hyogo Medical University Hospital

Nishinomiya-Shi, Hyôgo, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Kanazawa Medical University Hospital

Kahoku, Ishikawa-ken, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Kyôto, Japan

Kyoto University Hospital

Kyoto, Kyôto, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Sasebo Chuo Hospital

Sasebo-Shi, Nagasaki, Japan

Kurashiki Medical Clinic

Kurashiki-Shi, Okayama-ken, Japan

Saitama Medical University Hospital

Iruma-gun, Saitama, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Nippon Medical School Hospital

Bunkyo-Ku, Tokyo, Japan

St. Luke's International Hospital

Chuo-Ku, Tokyo, Japan

Tokyo Medical Center

Meguro-Ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Nihon University Itabashi Hospital

tabashi City, Tokyo, Japan

Mediadvance Clinical S.A.P.I. de C.V.

Parques de San Felipe, Chihuahua, Mexico

ONCOR - Centro de Infusion e Investigación Oncologia de Saltillo S.C

Saltillo, Coahuila, Mexico

CIMAB SA de CV

Torreón Centro, Coahuila, Mexico

Centro de Investigación en Artritis y Osteoporosis - PPDS

Mexicali, Estado de Baja California, Mexico

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Jalisco, Mexico

Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS

Guadalajara, Jalisco, Mexico

Cryptex Investigación Clínica, S.A. de C.V.

Mexico City, Mexico City, Mexico

Centro de Investigación y Tratamiento Reumatológico S.C

San Miguel Chapultepec, Mexico City, Mexico

Unidad de Atencion Medica e Investigacion en Salud

Mérida, Yucatán, Mexico

Centro de Investigacion Farmacologica Del Bajio Sc

León, Mexico

Consultorio de Reumatologia

México, Mexico

Clinstile, S.A. de C.V.

México, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Mitras Centro, Mexico

Accelerium, S. de R.L. de C.V. - PPDS

Monterrey, Mexico

Oaxaca Site Management Organization - Clinic - OSMO - PPDS

Oaxaca City, Mexico

Optimal Clinical Trials Ltd - PPDS

Auckland, New Zealand

Aotearoa Clinical Trials Trust

Auckland, New Zealand

Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)

Hamilton, New Zealand

Clinica San Antonio S.A.C

Trujillo, La Libertad, Peru

Clinica San Juan Bautista

San Juan de Lurigancho, Lima region, Peru

Hogar Clinica San Juan de Dios - Arequipa

Arequipa, Peru

Hospital Militar Central Luis Arias Schereiber

Lima, Peru

Clínica Internacional San Borja-Avenida Guardia Civil 385

Lima, Peru

Instituto de Ginecologia y Reproduccion - PPDS

Lima, Peru

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada

Pueblo Libre, Peru

Pratia Poznan - PPDS

Poznan, Greater Poland Voivodeship, Poland

Med-Polonia Sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland

Prywatna Praktyka Lekarska Pawel Hrycaj

Poznan, Greater Poland Voivodeship, Poland

Malopolskie Centrum Kliniczne

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne Oporow

Wroclaw, Lower Silesian Voivodeship, Poland

Dolnoslaski Szpital Specjalistyczny im. T. Marciniaka, Centrum Medycyny Ratunkowej

Wroclaw, Lower Silesian Voivodeship, Poland

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, Poland

Reumed Sp. z o.o.

Lublin, Lublin Voivodeship, Poland

FutureMeds - Warszawa Centrum - PPDS