RecruitingPhase 3NCT06747949

A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Sponsor

Amgen

Enrollment

844 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Sjögren's Syndrome

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term extension study for people who participated in a previous clinical trial of dazodalibep — a drug being tested for Sjögren's Syndrome, an autoimmune condition that mainly causes dry eyes and dry mouth. The purpose is to continue monitoring safety and effectiveness beyond the original 48-week study. **You may be eligible if...** - You previously completed the full 48-week treatment period in one of the Phase 3 dazodalibep trials (HZNP-DAZ-301 or HZNP-DAZ-303) - You received either dazodalibep or placebo during that trial - You are able to begin this extension study within 28 days of completing the prior trial **You may NOT be eligible if...** - You have a significant active infection at the time of enrollment - You did not complete the full duration of the prior trial - You have medical conditions that, in the investigator's opinion, make continued participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDazodalibep

Dazodalibep will be given intravenously (IV).

Locations(174)

Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, 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

Samy Metyas MD Inc

Covina, California, United States

UCSD Altman Clinical and Translational Research Institute Building

La Jolla, 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

BayCare Medical Group Primary Care and Rheumatology - Tampa

Tampa, Florida, United States

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Shores Rheumatology

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

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

Murfreesboro Medical Clinic Westlawn

Murfreesboro, Tennessee, United States

Accurate Clinical Management-Baytown

Baytown, Texas, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

R & H Clinical Research-777 S Fry Rd

Katy, Texas, United States

Houston Rheumatology & Arthritis Specialists - PLLC - PPDS

Katy, Texas, United States

Biopharma Informatic - Ridge Road - PPDS

McAllen, Texas, United States

Advanced Rheumatology of Houston

The Woodlands, Texas, United States

DM Clinical Research - Migraine and COPD - PPDS

Tomball, Texas, United States

Western Washington Medical Group, Bothell - Rheumatology

Bothell, Washington, United States

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, United States

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Ciudad Autónoma de Buenos Aires, 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

DOM Centro de Reumatología

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Medico Privado de Reumatologia - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Aprillus Asistencia e Investigacion - Terrada 89

Buenos Aires, Argentina

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, Argentina

Sanatorio Agote - Swiss Medical Group - PPDS

Buenos Aires, Argentina

Centro Medico Arsema

Buenos Aires, Argentina

Sanatorio Allende S.A.-Hipolito Yrigoyen 384

Córdoba, Argentina

Framingham Centro Médico

La Plata, 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

Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná, Brazil

LMK Servicos Medicos SS

Porto Alegre, Rio Grande do Sul, Brazil

Clinique de Rhumatologie Du Centre Du Quebec

Trois-Rivières, Quebec, Canada

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Valparaiso, Chile

Enroll SpA - Dr. Manuel Barros Borgono - PPDS

Providencia, Chile

BIOCINETIC Ltda

Santiago, Chile

Centro de especialidades médicas Vanguardia

Temuco, Chile

Clinical Research Chile SpA - PPDS

Valdivia, Chile

Polyclinic Bonifarm

Zagreb, City of Zagreb, Croatia

University Hospital of Split

Split, Croatia

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, France

CHU de Brest - Hôpital La Cavale Blanche

Brest, France

GHRMSA - Hôpital 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

MVZ Rheuma

Hamburg, Germany

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.

Hódmezovásárhely, 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

Kafr Saba, Central District, Israel

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Tel Aviv, Israel

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

Udine, Friuli Venezia Giulia, Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

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

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Italy

AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Chubu Rosai Hospital

Nagoya-shi, Akita, Japan

Japan Community Health Care Organization (JCHO) Chukyo Hospital

Nagoya-shi, Akita, Japan

Daido Clinic

Nagoya, Akita, 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

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 Moroyama-Machi, Saitama, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

St. Luke's International Hospital

Chuo-Ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashi-Ku, Tokyo, Japan

Tokyo Medical Center

Meguro-Ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

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

Parques de San Felipe, Chihuahua, 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

Centro de Investigación y Tratamiento Reumatológico S.C

Mexico City, Mexico City, Mexico

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

Mexico City, Mexico City, Mexico

Clinstile, S.A. de C.V.

Mexico City, Mexico

Unidad de Atención Medica e Investigación en Salud

Mérida, Mexico

Consultorio de Reumatologia

México, Mexico

Optimal Clinical Trials Ltd - PPDS

Auckland, North Island, New Zealand

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

Hamilton, New Zealand

Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS

Papatoetoe, New Zealand

Clinica San Antonio S.A.C

Trujillo, La Libertad, Peru

Medicentro Biociencias Peru S.R.L.

Pueblo Libre, Lima region, Peru

Hospital Militar Central Luis Arias Schereiber

Jesus Maria, Peru

Instituto de Ginecologia y Reproduccion - PPDS

Santiago de Surco, Peru

Pratia Poznan - PPDS

Poznan, Greater Poland Voivodeship, Poland

Med-Polonia Sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland

Malopolskie Centrum Kliniczne

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne Oporow

Wroclaw, Lower Silesian Voivodeship, Poland

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, Poland

Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4

Lublin, Lublin Voivodeship, Poland

MICS Centrum Medyczne Warszawa, Wronia - MICS

Warsaw, Masovian Voivodeship, Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship, Poland

WIM-PIB, Centralny Szpital Kliniczny MON

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne K2J2 - Wołomin

Wołomin, Masovian Voivodeship, Poland

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.

Malbork, Pomeranian Voivodeship, Poland

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, Poland

Centrum Medyczne Pratia Katowice - PPDS

Katowice, Poland

Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa

Krakow, Poland

Centrum Medyczne PROMED- Olszanska 5G

Krakow, Poland

FutureMeds - Lodz - PPDS

Lodz, Poland

Twoja Przychodnia PCM

Poznan, Poland

Prywatna Praktyka Lekarska Pawel Hrycaj

Poznan, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher

Warsaw, Poland

ETG Warszawa - PPDS

Warsaw, Poland

FutureMeds - Targowek - PPDS

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213

Wroclaw, Poland

Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3

Wroclaw, Poland

FutureMeds - Wroclaw - PPDS

Wroclaw, Poland

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Lisbon District, Portugal

ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS

Lisbon, Lisbon District, Portugal

Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima

Ponte de Lima, Portugal

ULS de Gaia/Espinho, EPE - Unidade I

Vila Nova de Gaia, Portugal

Military Medical Academy

Belgrade, Belgrade, Serbia

Institute of Rheumatology - PPDS

Belgrade, Serbia

Klinika za Alergologiju i Imunologiju

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Clinical Centre of Vojvodina

Novi Sad, Serbia

Special Hospital For Rheumatic Diseases Novi Sad

Novi Sad, Serbia

University Clinical Centre Maribor

Maribor, Slovenia

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Fundacio Hospital de l'Esperit Sant

Santa Coloma de Gramenet, Barcelona, Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Quironsalud Infanta Luisa

Seville, Spain

Hospital Universitario de Valme

Seville, Spain

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Taipei Medical University Hospital - PPDS

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Chapel Allerton Hospital - PPDS

Leeds, United Kingdom

Mile End Hospital - PPDS

London, United Kingdom

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NCT06747949

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