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ACTIVE NOT RECRUITING

NCT06245408

PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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

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 Symptom State (HZNP-DAZ-303)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

434

Start Date

2024-04-08

Completion Date

2026-12-17

Last Updated

2026-01-08

Healthy Volunteers

Conditions

Sjögren's Syndrome (SS)

Interventions

DRUG

Dazodalibep

IV infusion

DRUG

Placebo

IV infusion

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.

Locations (194)

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

Medvin Clinical Research - Covina

Covina, California, United States

UCSD Altman Clinical and Translational Research Institute Building

La Jolla, California, United States

Inland Rheumatology Clinical Trials Incorporated

Upland, California, United States

Medvin Clinical Research

Whittier, 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 Primary Care and Rheumatology - Tampa

Tampa, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Tufts Medical Center - Rheumatology Research Office - PPDS

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

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, 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, 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

Accurate Clinical Management-Baytown

Baytown, Texas, United States

Precision Comprehensive Clinical Research Solutions

Grapevine, Texas, United States

R & H Clinical Research-777 S Fry Rd

Katy, Texas, United States

Texas Arthritis & Rheumatology Associates

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

Advanced Rheumatology of Houston - The Woodlands

The Woodlands, Texas, United States

DM Clinical Research - Migraine and COPD - PPDS

Tomball, Texas, United States

Western Washington Medical Group

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

Sanatorio Guemes

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

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Ciudad Autónoma de BuenosAires, 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

Sanatorio Allende S.A

Córdoba, 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, Belgium

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

Salvador, Estado de Bahia, 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

Clinical Research Chile SpA - PPDS

Valdivia, Los Ríos Region, Chile

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Región de Valparaíso, Chile

BIOCINETIC Ltda

Peñalolén, Región-MetropolitanadeSantiago, Chile

Enroll SpA - Dr. Manuel Barros Borgono - PPDS

Santiago, Región-MetropolitanadeSantiago, Chile

Clinical Center Zagreb - Oncology - Salata 7 - PPDS

Zagreb, City of Zagreb, Croatia

Clinical Hospital Sveti Duh

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

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, France

CHU de Brest - Hôpital La Cavale Blanche

Brest, France

Hopital Emile Muller

Mulhouse, France

AP-HP - Hôpital Saint Antoine

Paris, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

University Clinic Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

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

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

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

Budapest, Hungary

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

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Piedmont, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, Italy

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

Catania, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, 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

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

CIMAB SA de CV

Torreón Centro, Coahuila, Mexico

Centro de Investigación en Artritis y Osteoporosis - PPDS

Mexicali, Estado de Baja California, Mexico

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

Americana, 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

Oaxaca Site Management Organization - Clinic - OSMO - PPDS

Centro, Oaxaca, Mexico

Consultorio de Reumatologia

México, Mexico

Clinstile, S.A. de C.V.

México, Mexico

Hospital Universitario Dr. Jose Eleuterio González

Mitras Centro, Mexico

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

Monterrey, Mexico

Optimal Clinical Trials Ltd - PPDS

Auckland, North Island, New Zealand

Aotearoa Clinical Trials Trust

Auckland, New Zealand

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 Peruano del Hueso y la Articulacion S.A.C.

Lima, Peru

Instituto de Ginecologia y Reproduccion - PPDS

Lima, Peru

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada

Pueblo Libre, Peru

Malopolskie Centrum Kliniczne

Krakow, Lesser Poland Voivodeship, Poland

FutureMeds - Wroclaw - PPDS

Wroclaw, Lower Silesian Voivodeship, Poland

Centrum Medyczne Oporow

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