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

PHASE3RecruitingINTERVENTIONAL
Enrollment

435

Participants

Timeline

Start Date

April 8, 2024

Primary Completion Date

September 2, 2026

Study Completion Date

November 3, 2026

Conditions
Sjögren's Syndrome (SS)
Interventions
DRUG

Dazodalibep

IV infusion

DRUG

Placebo

IV infusion

Trial Locations (209)

11

RECRUITING

Hospital Militar Central Luis Arias Schereiber, Lima

110

RECRUITING

Taipei Medical University Hospital - PPDS, Taipei

333

RECRUITING

Chang Gung Memorial Hospital, Linkou, Taoyuan

407

RECRUITING

Taichung Veterans General Hospital, Taichung

807

RECRUITING

Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung City

1000

RECRUITING

University Medical Centre Ljubljana-Vodnikova cesta 62, Ljubljana

1003

RECRUITING

Optimal Clinical Trials Ltd - PPDS, Auckland

1097

RECRUITING

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Szent Laszlo Korhaz Teleph, Budapest

2000

RECRUITING

University Clinical Centre Maribor, Maribor

2025

RECRUITING

Aotearoa Clinical Trials Trust, Auckland

3214

RECRUITING

Waikato Hospital, Hamilton

4032

RECRUITING

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus, Debrecen

5000

RECRUITING

Odense Universitets Hospital, Odense C

5011

RECRUITING

The Queen Elizabeth Hospital, Woodville South

5700

RECRUITING

Bekes Varmegyei Kozponti Korhaz, Gyula

6100

RECRUITING

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

6800

RECRUITING

Vasarhelyi Sarkanyfu Kft., Hódmezővásárhely

9000

RECRUITING

UZ Gent, Ghent

10000

RECRUITING

Clinical Center Zagreb - Oncology - Salata 7 - PPDS, Zagreb

RECRUITING

Clinical Hospital Sveti Duh, Zagreb

RECRUITING

Polyclinic Bonifarm, Zagreb

10126

RECRUITING

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

11000

RECRUITING

Institute of Rheumatology - PPDS, Belgrade

RECRUITING

Military Medical Academy, Belgrade

11850

RECRUITING

Centro de Investigación y Tratamiento Reumatológico S.C, San Miguel Chapultepec

13007

RECRUITING

Centro de Investigacion Clinica Trujillo EIRL, Trujillo

14004

RECRUITING

C.H. Regional Reina Sofia - PPDS, Córdoba

15001

RECRUITING

Clínica Internacional San Borja-Avenida Guardia Civil 385, Lima

15006

RECRUITING

Hospital Universitario A Coruña, A Coruña

15046

RECRUITING

Instituto Peruano del Hueso y la Articulacion S.A.C., Lima

15431

RECRUITING

Clinica San Juan Bautista, San Juan de Lurigancho

17493

RECRUITING

Rheumazentrum Greifswald, Greifswald Hansestadt

18209

RECRUITING

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

20095

RECRUITING

MVZ Rheuma, Hamburg

20122

RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

RECRUITING

ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini, Milan

21000

RECRUITING

University Hospital of Split-Spinciceva 1, Split

RECRUITING

Clinical Centre of Vojvodina, Novi Sad

RECRUITING

Special Hospital For Rheumatic Diseases Novi Sad, Novi Sad

21200

RECRUITING

Centro de Investigación en Artritis y Osteoporosis - PPDS, Mexicali

25279

RECRUITING

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

27000

RECRUITING

CIMAB SA de CV, Torreón Centro

28007

RECRUITING

Hospital General Universitario Gregorio Marañon, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28046

RECRUITING

Hospital Universitario La Paz - PPDS, Madrid

28100

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità, Novara

28144

RECRUITING

Onsite Clinical Solutions, LLC - Salisbury, Salisbury

29609

RECRUITING

CHU de Brest - Hôpital La Cavale Blanche, Brest

31000

RECRUITING

Clinical Hospital Centre Osijek, Osijek

31203

RECRUITING

Mediadvance Clinical S.A.P.I. de C.V., Parques de San Felipe

33000

RECRUITING

CHU de Bordeaux - Hôpital Saint-André, Bordeaux

33100

RECRUITING

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

34000

RECRUITING

University Clinical Center Kragujevac, Kragujevac

37134

RECRUITING

Azienda Ospedaliera Universitaria Integrata Di Verona, Verona

38001

RECRUITING

Hospital Universitario Hospiten Rambla de Tenerife, Santa Cruz de Tenerife

38330

RECRUITING

Hospital Universitario de Canarias, San Cristóbal de La Laguna

40447

RECRUITING

China Medical University Hospital - PPDS, Taichung

41010

RECRUITING

Hospital Quironsalud Infanta Luisa, Seville

41014

RECRUITING

Hospital Nuestra Señora de Valme, Seville

42121

RECRUITING

AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova, Reggio Emilia

44160

RECRUITING

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

44690

RECRUITING

Centro de Estudios de Investigacion Basica Y Clinica SC, Guadalajara

46017

RECRUITING

Hospital Universitario Doctor Peset, Valencia

48013

RECRUITING

Hospital Universitario de Basurto, Bilbao

48081

RECRUITING

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

50134

RECRUITING

Azienda Ospedaliera Universitaria Careggi, Florence

56126

RECRUITING

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara, Pisa

61469

RECRUITING

Chonnam National University Hospital, Gwangju

64000

RECRUITING

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

64460

RECRUITING

Hospital Universitario Dr. Jose Eleuterio González, Mitras Centro

67200

RECRUITING

Hôpitaux Universitaires de Strasbourg, Strasbourg

68000

RECRUITING

Oaxaca Site Management Organization - Clinic - OSMO - PPDS, Centro

68100

RECRUITING

Hopital Emile Muller, Mulhouse

69120

RECRUITING

University Clinic Heidelberg, Heidelberg

75571

RECRUITING

AP-HP - Hôpital Saint Antoine, Paris

77375

RECRUITING

DM Clinical Research - Migraine and COPD - PPDS, Tomball

77382

RECRUITING

Advanced Rheumatology of Houston - The Woodlands, The Woodlands

77521

RECRUITING

Accurate Clinical Management-Baytown, Baytown

78501

RECRUITING

Valley Arthritis Center, McAllen

90602

RECRUITING

Medvin Clinical Research, Whittier

91723

RECRUITING

Medvin Clinical Research - Covina, Covina

95121

RECRUITING

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

97000

RECRUITING

Unidad de Atencion Medica e Investigacion en Salud, Mérida

2520000

RECRUITING

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas, Viña del Mar

5090000

RECRUITING

Clinical Research Chile SpA - PPDS, Valdivia

7910000

RECRUITING

BIOCINETIC Ltda, Peñalolén

85225-2915

RECRUITING

Arizona Research Clinic PLLC, Chandler

86001-6299

RECRUITING

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

85297-7338

RECRUITING

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

85306-9800

RECRUITING

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

85704-1140

RECRUITING

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

92037-1337

RECRUITING

UCSD Altman Clinical and Translational Research Institute Building, La Jolla

91786-4951

RECRUITING

Inland Rheumatology Clinical Trials Incorporated, Upland

80528-3404

RECRUITING

Tekton Research, LLC - 2121 E Harmony Rd - PPDS, Fort Collins

34205-1704

RECRUITING

Bradenton Research Center Inc, Bradenton

33765-2616

RECRUITING

Clinical Research of West Florida Inc - Clearwater, Clearwater

33136-1011

RECRUITING

University of Miami - Leonard M. Miller School of Medicine, Miami

33321-2956

RECRUITING

West Broward Rheumatology Associates, Inc., Tamarac

33614-7101

RECRUITING

BayCare Medical Group Primary Care and Rheumatology - Tampa, Tampa

61114-4937

RECRUITING

OrthoIllinois, LTD, Rockford

66160-8500

RECRUITING

University of Kansas Medical Center, Kansas City

02111-1552

RECRUITING

Tufts Medical Center - Rheumatology Research Office - PPDS, Boston

64151-5100

RECRUITING

Kansas City Physician Partners-8350 N Saint Clair Ave, Kansas City

08043-4509

RECRUITING

Arthritis, Rheumatic & Bone Disease Associates - P, Voorhees Township

87102-1710

RECRUITING

Albuquerque Center for Rheumatology, Albuquerque

11201-5501

RECRUITING

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

27710-0001

RECRUITING

Duke Early Phase Clinical Research Unit, Durham

45342-3585

RECRUITING

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg, Miamisburg

43614-2595

RECRUITING

University of Toledo Medical Center, Toledo

45377-9474

RECRUITING

STAT Research-600 Aviator Ct, Vandalia

79124-1601

RECRUITING

Amarillo Center For Clinical Research, Amarillo

76051-3143

RECRUITING

Precision Comprehensive Clinical Research Solutions, Grapevine

77450-2297

RECRUITING

R & H Clinical Research-777 S Fry Rd, Katy

77494-1341

RECRUITING

Houston Rheumatology and Arthritis Specialists, PLLC, Katy

78229-3901

RECRUITING

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

98021-4418

RECRUITING

Western Washington Medical Group, Bothell

25801-2805

RECRUITING

Rheumatology and Pulmonary Clinic, Beckley

C1425EOE

RECRUITING

Sanatorio Agote - Swiss Medical Group - PPDS, Ciudad Autónoma de Buenos Aires

C1425EUG

RECRUITING

Sanatorio Guemes, Ciudad Autónoma de Buenos Aires

B1900

RECRUITING

Framingham Centro Médico, La Plata

B1878DVB

RECRUITING

Instituto CER S.A., Quilmes

B1878GEG

RECRUITING

Instituto de Investigaciones Clinicas Quilmes SRL, Quilmes

C1121ADC

RECRUITING

Hospital General de Agudos Dr. José María Ramos Mejia, Buenos Aires

C1426

RECRUITING

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS, Buenos Aires

T4000AXL

RECRUITING

Centro de Investigaciones Médicas Tucumán - PPDS, San Miguel de Tucumán

RECRUITING

Centro de Investigaciones Reumatológicas, San Miguel de Tucumán

T4000IHE

RECRUITING

Clínica Mayo de U.M.C.B. S.R.L, San Miguel de Tucumán

C1111AAH

RECRUITING

DOM Centro de Reumatología, Buenos Aires

C1406AGA

RECRUITING

Aprillus Asistencia e Investigacion de Arcis Salud SRL, Buenos Aires

C1427CCL

RECRUITING

Centro Medico Arsema, Buenos Aires

X5000JHQ

RECRUITING

Sanatorio Allende S.A, Córdoba

J5400DIL

RECRUITING

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan, San Juan

40150-150

RECRUITING

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

30150-221

RECRUITING

Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS, Belo Horizonte

80030-110

RECRUITING

Centro de Estudos em Terapias Inovadoras, Curitiba

90480-000

RECRUITING

LMK Servicos Medicos SS, Porto Alegre

G9A 3X2

RECRUITING

Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille, Trois-Rivières

Unknown

RECRUITING

Enroll SpA - Dr. Manuel Barros Borgono - PPDS, Santiago

RECRUITING

Clinstile, S.A. de C.V., México

09117

RECRUITING

DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein, Chemnitz

115 21

RECRUITING

Naval Hospital of Athens, Athens

115 27

RECRUITING

Laiko General Hospital of Athens, Athens

166 73

RECRUITING

General Hospital ''Asklepieio Voulas'', Voula

411 10

RECRUITING

University General Hospital of Larissa, Larissa

546 36

RECRUITING

Euromedica Kianous Stavros, Thessaloniki

00128

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico, Rome

00168

RECRUITING

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS, Rome

455-0018

RECRUITING

Chubu Rosai Hospital, Nagoya

457-0866

RECRUITING

Japan Community Health Care Organization (JCHO) Chukyo Hospital, Nagoya

457-8511

RECRUITING

Daido Clinic, Nagoya

060-8543

RECRUITING

Sapporo Medical University Hospital, Sapporo

060-8648

RECRUITING

Hokkaido University Hospital, Sapporo

807-8556

RECRUITING

Hospital of the University of Occupational and Environmental Health, Japan, Kita Kyushu-shi

663-8501

RECRUITING

Hyogo Medical University Hospital, Nishinomiya-Shi

305-8576

RECRUITING

University of Tsukuba Hospital, Tsukuba

920-0293

RECRUITING

Kanazawa Medical University Hospital, Kahoku

920-8641

RECRUITING

Kanazawa University Hospital, Kanazawa

245-8575

RECRUITING

National Hospital Organization Yokohama Medical Center, Yokohama

602-8566

RECRUITING

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

606-8507

RECRUITING

Kyoto University Hospital, Kyoto

852-8501

RECRUITING

Nagasaki University Hospital, Nagasaki

857-1165

RECRUITING

Sasebo Chuo Hospital, Sasebo-Shi

710-0824

RECRUITING

Kurashiki Medical Clinic, Kurashiki-Shi

350-0495

RECRUITING

Saitama Medical University Hospital, Iruma-gun

431-3192

RECRUITING

Hamamatsu University Hospital, Hamamatsu

104-0044

RECRUITING

St. Luke's International Hospital, Chuo-Ku

152-8902

RECRUITING

Tokyo Medical Center, Meguro-Ku

160-8582

RECRUITING

Keio University Hospital, Shinjuku-Ku

173-8610

RECRUITING

Nihon University Itabashi Hospital, tabashi City

07760

RECRUITING

Consultorio de Reumatologia, México

04013

RECRUITING

Hogar Clinica San Juan de Dios - Arequipa, Arequipa

Lima 33

RECRUITING

Instituto de Ginecologia y Reproduccion - PPDS, Lima

Lima 21

RECRUITING

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada, Pueblo Libre

60-693

RECRUITING

Med-Polonia Sp. z o.o., Poznan

61-545

RECRUITING

Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola M, Poznan

30-149

RECRUITING

Malopolskie Centrum Kliniczne, Krakow

50-088

RECRUITING

FutureMeds - Wroclaw - PPDS, Wroclaw

52-416

RECRUITING

Centrum Medyczne Oporow, Wroclaw

54-049

RECRUITING

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

20-412

RECRUITING

ETG Lublin - PPDS, Lublin

20-607

RECRUITING

Reumed Sp. z o.o. Poradnia Specjalistyczna Filia 2 Onyksowa, Lublin

00-215

RECRUITING

FutureMeds - Warszawa Centrum - PPDS, Warsaw

00-874

RECRUITING

MICS Centrum Medyczne Warszawa - MICS - PPDS, Warsaw

02-172

RECRUITING

MTZ Clinical Research Powered by PRATIA - PPDS, Warsaw

02-637

RECRUITING

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

02-665

RECRUITING

Klinika Reuma Park sp . zoo Sp.k., Warsaw

05-200

RECRUITING

K2J2 Medical Center, Wołomin

82-200

RECRUITING

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

71-252

RECRUITING

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie, Szczecin

85-168

RECRUITING

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

82-300

RECRUITING

Ambulatorium Sp z o.o., Elblag

40-081

RECRUITING

Centrum Medyczne Katowice - PRATIA - PPDS, Katowice

30-363

RECRUITING

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

91-363

RECRUITING

FutureMeds - Lodz - PPDS, Lodz

60-324

RECRUITING

Twoja Przychodnia PCM, Poznan

04-141

RECRUITING

WIM-PIB, Centralny Szpital Kliniczny MON, Warsaw

50-556

RECRUITING

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

53-034

RECRUITING

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

1300-344

RECRUITING

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz, Lisbon

1649-035

RECRUITING

Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS, Lisbon

4990-041

RECRUITING

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

4434-502

RECRUITING

ULS de Gaia/Espinho, EPE - Unidade I, Vila Nova de Gaia

00917

RECRUITING

GCM Medical Group, PSC -62 Calle Jose Marti, San Juan

06591

RECRUITING

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

08923

RECRUITING

Fundacio Hospital de l'Esperit Sant, Santa Coloma de Gramenet(Barcelona)

01009

RECRUITING

Hospital Universitario Araba - Txagorritxu, Vitoria-Gasteiz

NW3 2QG

RECRUITING

Royal Free Hospital - PPDS, London

LS7 4SA

RECRUITING

Chapel Allerton Hospital - PPDS, Leeds

EC1M 6BQ

RECRUITING

William Harvey Research Institute - PPDS, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT06245408 - A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State | Biotech Hunter | Biotech Hunter