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NCT06747949PHASE3Recruiting

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

Amgen

Start Date

2/25/2025

Completion Date

12/11/2029

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participant has provided informed consent before initiation of any study specific activities/procedures. * Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303). * Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication. * Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded. * Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration. * Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety. * Individuals who plan to receive live (attenuated) vaccine during the LTE study. * Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product. * Female participants who are pregnant or lactating or planning to become pregnant during the study. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.

Interventions

DRUG

Dazodalibep

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Conditions

Sjögren's Syndrome

Locations

Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona 85392

United States

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

Flagstaff, Arizona 86001-6269

United States

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

Gilbert, Arizona 85297-7336

United States

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

Glendale, Arizona 85306-9800

United States

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

Tucson, Arizona 85704-1139

United States

Samy Metyas MD Inc

Covina, California 91723

United States

UCSD Altman Clinical and Translational Research Institute Building

La Jolla, California 92037-1337

United States

Tekton Research, LLC - 2121 E Harmony Rd - PPDS

Fort Collins, Colorado 80528-3400

United States

Bradenton Research Center Inc

Bradenton, Florida 34205-1704

United States

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida 33765-2616

United States

BayCare Medical Group Primary Care and Rheumatology - Tampa

Tampa, Florida 33614-7101

United States

Tufts University School of Dental Medicine

Boston, Massachusetts 02111-1527

United States

Shores Rheumatology

Saint Clair Shores, Michigan 48081-1274

United States

Kansas City Physician Partners-8350 N Saint Clair Ave

Kansas City, Missouri 64151

United States

Arthritis, Rheumatic & Bone Disease Associates - Voorhees

Voorhees Township, New Jersey 08043-4501

United States

Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd

Charlotte, North Carolina 28207-1100

United States

Duke Early Phase Clinical Research Unit - PPDS

Durham, North Carolina 27710-0001

United States

Onsite Clinical Solutions, LLC - Salisbury

Salisbury, North Carolina 28144

United States

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg

Miamisburg, Ohio 45342-3585

United States

University of Toledo Medical Center

Toledo, Ohio 43614-2595

United States

STAT Research-600 Aviator Ct

Vandalia, Ohio 45377-9474

United States

Murfreesboro Medical Clinic Westlawn

Murfreesboro, Tennessee 37128

United States

Accurate Clinical Management-Baytown

Baytown, Texas 77521-2279

United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas 76034-5913

United States

R & H Clinical Research-777 S Fry Rd

Katy, Texas 77450-2297

United States

Houston Rheumatology & Arthritis Specialists - PLLC - PPDS

Katy, Texas 77494-1341

United States

Biopharma Informatic - Ridge Road - PPDS

McAllen, Texas 78503-1527

United States

Advanced Rheumatology of Houston

The Woodlands, Texas 77382-2935

United States

DM Clinical Research - Migraine and COPD - PPDS

Tomball, Texas 77375

United States

Western Washington Medical Group, Bothell - Rheumatology

Bothell, Washington 98021

United States

Rheumatology and Pulmonary Clinic

Beckley, West Virginia 25801-2805

United States

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP

Argentina

Instituto CER S.A.

Quilmes, Buenos Aires B1878DVB

Argentina

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires B1878GEG

Argentina

MR Medicina Reumatologica

San Fernando, Buenos Aires B1646GHP

Argentina

DOM Centro de Reumatología

Buenos Aires, Ciudad Autónoma de BuenosAires C1111

Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

Centro Medico Privado de Reumatologia - PPDS

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province T4000IHE

Argentina

Aprillus Asistencia e Investigacion - Terrada 89

Buenos Aires, 1406

Argentina

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, C1121ADC

Argentina

Sanatorio Agote - Swiss Medical Group - PPDS

Buenos Aires, C1425EOE

Argentina

Centro Medico Arsema

Buenos Aires, C1427CCL

Argentina

Sanatorio Allende S.A.-Hipolito Yrigoyen 384

Córdoba, X5000JHQ

Argentina

Framingham Centro Médico

La Plata, B1902COS

Argentina

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

San Juan, J5402DIL

Argentina

The Queen Elizabeth Hospital

Woodville South, South Australia 5011

Australia

UZ Gent

Ghent, 9000

Belgium

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

Salvador, Estado de Bahia 40150-150

Brazil

Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná 80030-110

Brazil

LMK Servicos Medicos SS

Porto Alegre, Rio Grande do Sul 90480-000

Brazil

Clinique de Rhumatologie Du Centre Du Quebec

Trois-Rivières, Quebec G8Z 1Y2

Canada

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Valparaiso 2520000

Chile

Enroll SpA - Dr. Manuel Barros Borgono - PPDS

Providencia, 7500000

Chile

BIOCINETIC Ltda

Santiago, 8350595

Chile

Centro de especialidades médicas Vanguardia

Temuco, 4810345

Chile

Clinical Research Chile SpA - PPDS

Valdivia, 5110683

Chile

Polyclinic Bonifarm

Zagreb, City of Zagreb 10000

Croatia

University Hospital of Split

Split, 21000

Croatia

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, 33000

France

CHU de Brest - Hôpital La Cavale Blanche

Brest, 29200

France

GHRMSA - Hôpital Emile Muller

Mulhouse, 68100

France

AP-HP - Hôpital Saint Antoine

Paris, 75012

France

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091

France

University Clinic Heidelberg

Heidelberg, Baden-Wurttemberg 69120

Germany

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

Bad Doberan, Mecklenburg-Vorpommern 18209

Germany

Rheumazentrum Greifswald

Greifswald Hansestadt, Mecklenburg-Vorpommern 17493

Germany

MVZ Rheuma

Hamburg, 20095

Germany

Naval Hospital of Athens

Athens, Attica 115 21

Greece

Laiko General Hospital of Athens

Athens, Attica 115 27

Greece

University General Hospital of Larissa

Larissa, Larisa 411 10

Greece

Euromedica Kianous Stavros

Thessaloniki, 546 36

Greece

Bekes Varmegyei Kozponti Korhaz

Gyula, Bekes County 5700

Hungary

Vasarhelyi Sarkanyfu Kft.

Hódmezovásárhely, Csongrád megye 6800

Hungary

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar 4032

Hungary

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

Budapest, 1097

Hungary

Meir Medical Center

Kafr Saba, Central District 4428164

Israel

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Tel Aviv 5262100

Israel

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

Udine, Friuli Venezia Giulia 33100

Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio 00168

Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio 128

Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122

Italy

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

Turin, Piedmont 10126

Italy

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto 37126

Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, 56126

Italy

AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, 42123

Italy

Chubu Rosai Hospital

Nagoya-shi, Akita 455-0018

Japan

Japan Community Health Care Organization (JCHO) Chukyo Hospital

Nagoya-shi, Akita 457-0866

Japan

Daido Clinic

Nagoya, Akita 457-8511

Japan

Sapporo Medical University Hospital

Sapporo, Hokkaidô 060-8543

Japan

Hokkaido University Hospital

Sapporo, Hokkaidô 060-8648

Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kita Kyushu-shi, Hukuoka 807-8556

Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki 305-8576

Japan

Kanazawa Medical University Hospital

Kahoku, Ishikawa-ken 920-0293

Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken 920-8641

Japan

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa 245-8575

Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Kyôto 602-8566

Japan

Kyoto University Hospital

Kyoto, Kyôto 606-8507

Japan

Nagasaki University Hospital

Nagasaki, Nagasaki 852-8501

Japan

Sasebo Chuo Hospital

Sasebo-Shi, Nagasaki 857-1165

Japan

Kurashiki Medical Clinic

Kurashiki-Shi, Okayama-ken 710-0824

Japan

Saitama Medical University Hospital

Iruma-Gun Moroyama-Machi, Saitama 350-0451

Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka 431-3192

Japan

St. Luke's International Hospital

Chuo-Ku, Tokyo 104-0044

Japan

Nihon University Itabashi Hospital

Itabashi-Ku, Tokyo 173-0032

Japan

Tokyo Medical Center

Meguro-Ku, Tokyo 152-0021

Japan

Keio University Hospital

Shinjuku-Ku, Tokyo 160-8582

Japan

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

Parques de San Felipe, Chihuahua 31203

Mexico

Centro de Investigación en Artritis y Osteoporosis - PPDS

Mexicali, Estado de Baja California 21200

Mexico

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Jalisco 44690

Mexico

Centro de Investigación y Tratamiento Reumatológico S.C

Mexico City, Mexico City 11850

Mexico

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

Mexico City, Mexico City 6100

Mexico

Clinstile, S.A. de C.V.

Mexico City, 6700

Mexico

Unidad de Atención Medica e Investigación en Salud

Mérida, 97000

Mexico

Consultorio de Reumatologia

México, 7760

Mexico

Optimal Clinical Trials Ltd - PPDS

Auckland, North Island 1003

New Zealand

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

Hamilton, 3240

New Zealand

Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS

Papatoetoe, 2025

New Zealand

Clinica San Antonio S.A.C

Trujillo, La Libertad 13008

Peru

Medicentro Biociencias Peru S.R.L.

Pueblo Libre, Lima region 1508

Peru

Hospital Militar Central Luis Arias Schereiber

Jesus Maria, 15001

Peru

Instituto de Ginecologia y Reproduccion - PPDS

Santiago de Surco, 33

Peru

Pratia Poznan - PPDS

Poznan, Greater Poland Voivodeship 60-192

Poland

Med-Polonia Sp. z o.o.

Poznan, Greater Poland Voivodeship 60-693

Poland

Malopolskie Centrum Kliniczne

Krakow, Lesser Poland Voivodeship 30-149

Poland

Centrum Medyczne Oporow

Wroclaw, Lower Silesian Voivodeship 52-416

Poland

ETG Lublin - PPDS

Lublin, Lublin Voivodeship 20-412

Poland

Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4

Lublin, Lublin Voivodeship 20-607

Poland

MICS Centrum Medyczne Warszawa, Wronia - MICS

Warsaw, Masovian Voivodeship 00-874

Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship 02-172

Poland

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship 02-665

Poland

WIM-PIB, Centralny Szpital Kliniczny MON

Warsaw, Masovian Voivodeship 04-141

Poland

Centrum Medyczne K2J2 - Wołomin

Wołomin, Masovian Voivodeship 05-200

Poland

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

Malbork, Pomeranian Voivodeship 82-200

Poland

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85-065

Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168

Poland

Centrum Medyczne Pratia Katowice - PPDS

Katowice, 40-081

Poland

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

Krakow, 30-363

Poland

Centrum Medyczne PROMED- Olszanska 5G

Krakow, 31-513

Poland

FutureMeds - Lodz - PPDS

Lodz, 91-363

Poland

Twoja Przychodnia PCM

Poznan, 60-324

Poland

Prywatna Praktyka Lekarska Pawel Hrycaj

Poznan, 61-397

Poland

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

Warsaw, 02-637

Poland

ETG Warszawa - PPDS

Warsaw, 02-677

Poland

FutureMeds - Targowek - PPDS

Warsaw, 03-291

Poland

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

Wroclaw, 50-556

Poland

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

Wroclaw, 53-034

Poland

FutureMeds - Wroclaw - PPDS

Wroclaw, 53-673

Poland

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Lisbon District 1349-019

Portugal

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

Lisbon, Lisbon District 1649-035

Portugal

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

Ponte de Lima, 4990-150

Portugal

ULS de Gaia/Espinho, EPE - Unidade I

Vila Nova de Gaia, 4434-502

Portugal

Military Medical Academy

Belgrade, Belgrade 11000

Serbia

Institute of Rheumatology - PPDS

Belgrade, 11000

Serbia

Klinika za Alergologiju i Imunologiju

Belgrade, 112108

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

Clinical Centre of Vojvodina

Novi Sad, 21000

Serbia

Special Hospital For Rheumatic Diseases Novi Sad

Novi Sad, 21000

Serbia

University Clinical Centre Maribor

Maribor, 2000

Slovenia

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

Seoul, Seoul Teugbyeolsi 6591

South Korea

Fundacio Hospital de l'Esperit Sant

Santa Coloma de Gramenet, Barcelona 08923

Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba 14004

Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya 48013

Spain

Hospital Universitario Infanta Leonor

Madrid, 28031

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Quironsalud Infanta Luisa

Seville, 41010

Spain

Hospital Universitario de Valme

Seville, 41014

Spain

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, 80756

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

Taipei Medical University Hospital - PPDS

Taipei, 11031

Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, 33305

Taiwan

Queen Alexandra Hospital

Portsmouth, Hampshire PO6 3LY

United Kingdom

Chapel Allerton Hospital - PPDS

Leeds, LS7 4SA

United Kingdom

Mile End Hospital - PPDS

London, E1 4DG

United Kingdom