A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

651

Participants

Timeline

Start Date

January 24, 2024

Primary Completion Date

June 18, 2026

Study Completion Date

August 19, 2026

Conditions
Sjogren's Syndrome
Interventions
DRUG

Dazodalibep

IV infusion

DRUG

Placebo

IV infusion

Trial Locations (229)

11

Hospital Militar Central Luis Arias Schereiber, Lima

333

Chang Gung Memorial Hospital, Linkou, Gui Shan Qu

1003

Optimal Clinical Trials Ltd - PPDS, Auckland

1097

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

2025

Aotearoa Clinical Trials Trust, Auckland

3000

UZ Leuven, Leuven

3214

Waikato Hospital, Hamilton

4032

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus, Debrecen

5011

The Queen Elizabeth Hospital, Woodville South

5700

Bekes Varmegyei Kozponti Korhaz, Gyula

6800

Vasarhelyi Sarkanyfu Kft., Hódmezővásárhely

9000

UZ Gent, Ghent

10000

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

Polyclinic Bonifarm, Zagreb

10126

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

11000

Institute of Rheumatology - PPDS, Belgrade

Military Medical Academy, Belgrade

University Clinical Center of Serbia - Pasterova 2 - PPDS, Belgrade

11031

Taipei Medical University Hospital - PPDS, Taipei

11850

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

13001

Centro de Investigacion Clinica Trujillo E.I.R.L., Trujillo

14004

C.H. Regional Reina Sofia - PPDS, Córdoba

15001

Clínica Internacional San Borja-Avenida Guardia Civil 385, Lima

15046

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

15431

Clinica San Juan Bautista, San Juan de Lurigancho

17493

Rheumazentrum Greifswald, Greifswald Hansestadt

18209

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

20095

MVZ Rheuma, Hamburg

20122

ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini, Milan

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

21000

University Hospital of Split-Spinciceva 1, Split

Clinical Centre of Vojvodina, Novi Sad

Special Hospital For Rheumatic Diseases Novi Sad, Novi Sad

21200

Centro de Investigación en Artritis y Osteoporosis - PPDS, Mexicali

25279

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

27000

CIMAB SA de CV, Torreón Centro

28032

Hospital Universitario Infanta Leonor, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28144

Onsite Clinical Solutions, LLC - Salisbury, Salisbury

28207

Arthritis and Osteoporosis Consultants of The Carolinas, Charlotte

29009

Hospital Regional Universitario de Malaga - Hospital Civil, Málaga

29609

CHU de Brest - Hôpital La Cavale Blanche, Brest

31000

Clinical Hospital Centre Osijek, Osijek

31203

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

33000

CHU de Bordeaux - Hôpital Saint-André, Bordeaux

33100

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

34000

University Clinical Center Kragujevac, Kragujevac

37128

Murfreesboro Medical Clinic Westlawn, Murfreesboro

37134

Azienda Ospedaliera Universitaria Integrata Di Verona, Verona

37160

Centro de Investigacion Farmacologica Del Bajio Sc, León

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

40705

Taichung Veterans General Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41010

Hospital Quironsalud Infanta Luisa, Seville

41014

Hospital Nuestra Señora de Valme, Seville

42055

CHU de Saint-Etienne - Hôpital Nord, Saint-Priest-en-Jarez

42121

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

44281

Meir Medical Center, Kfar Saba

44690

Centro de Estudios de Investigacion Basica Y Clinica SC, Guadalajara

45342

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg, Miamisburg

48013

Hospital Universitario de Basurto, Bilbao

50134

Azienda Ospedaliera Universitaria Careggi, Florence

56126

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara, Pisa

64000

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

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez, Mitras Centro

67200

Hôpitaux Universitaires de Strasbourg, Strasbourg

68000

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

68100

Hopital Emile Muller, Mulhouse

69120

University Clinic Heidelberg, Heidelberg

77375

DM Clinical Research - Migraine and COPD - PPDS, Tomball

77450

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

77521

Accurate Clinical Management-Baytown, Baytown

78501

Valley Arthritis Center, McAllen

80756

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

84119

Metrodora Institute, West Valley City

85392

Arizona Arthritis & Rheumatology Associates - Avondale, Avondale

91120

Hadassah Medical Center- Ein Kerem - PPDS, Jerusalem

94270

AP-HP - Hôpital Bicêtre, Le Kremlin-Bicêtre

95121

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

97000

Unidad de Atencion Medica e Investigacion en Salud, Mérida

98021

Western Washington Medical Group, Bothell - Rheumatology, Bothell

2520000

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

4780000

Centro de especialidades médicas Vanguardia, Temuco

5110683

Clinical Research Chile SpA - PPDS, Valdivia

5262100

The Chaim Sheba Medical Center - PPDS, Ramat Gan

7500587

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

8320000

BIOCINETIC Ltda, Santiago

85225-2915

Arizona Research Clinic PLLC, Chandler

86001-6299

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

85297-7338

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

85306-9800

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

85704-1140

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

92037-1337

UCSD Altman Clinical and Translational Research Institute Building, La Jolla

91786-4951

Inland Rheumatology Clinical Trials Incorporated, Upland

80528-3404

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

34205-1704

Bradenton Research Center Inc, Bradenton

33765-2616

Clinical Research of West Florida Inc - Clearwater, Clearwater

33136-1011

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

34652-4020

Suncoast Clinical Research - ATLAS - New Port Richey - PPDS, New Port Richey

32174-1140

Millennium Research, Ormond Beach

33321-2956

West Broward Rheumatology Associates, Inc., Tamarac

33614-7101

BayCare Medical Group, Tampa

30912-0004

Augusta University Medical Center-Augusta-1120 15th St, Augusta

61114-4937

OrthoIllinois, LTD, Rockford

66160-0001

University of Kansas Medical Center, Kansas City

02114-2621

Massachusetts General Hospital, Boston

48081-1274

Shores Rheumatology, Saint Clair Shores

64151-5100

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

08043-4509

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

11201-5501

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

27710-0001

Duke Early Phase Clinical Research Unit, Durham

45377-9474

STAT Research-600 Aviator Ct, Vandalia

29486-7887

Low Country Rheumatology PA-Summerville, Summerville

79124-1601

Amarillo Center For Clinical Research - ClinEdge - PPDS, Amarillo

78745-1470

Tekton Research, LLC - W Gate Blvd - Austin - PPDS, Austin

76051-3143

Precision Comprehensive Clinical Research Solutions, Grapevine

77054-2853

Prolato Clinical Research Center, Houston

78229-3901

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

98004-3016

Overlake Arthritis & Osteoporosis Center, Bellevue

25801-2805

Rheumatology and Pulmonary Clinic, Beckley

C1425EOE

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

C1425EUG

Sanatorio Guemes, Ciudad Autónoma de Buenos Aires

B1900

Framingham Centro Médico, La Plata

B1878DVB

Instituto CER S.A., Quilmes

B1878GEG

Instituto de Investigaciones Clinicas Quilmes SRL, Quilmes

B1646GHP

MR Medicina Reumatologica, San Fernando

C1121ADC

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

C1128AAF

Expertia S.A- Mautalén Salud e Investigación, Buenos Aires

C1417

Centro Privado de Medicina Familiar, Buenos Aires

C1426ABP

Consultorios Médicos Dr. Doreski - PPDS, Buenos Aires

X5000JHGQ

Sanatorio Allende S.A, Córdoba

T4000AXL

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

Centro de Investigaciones Reumatológicas, San Miguel de Tucumán

T4000IHE

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

C1111AAH

DOM Centro de Reumatología, Buenos Aires

C1406AGA

Aprillus Asistencia e Investigacion de Arcis Salud SRL, Buenos Aires

C1427CCL

Centro Medico Arsema, Buenos Aires

J5400DIL

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

40150-150

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

70200-730

AES - AS - L2IP - Instituto de Pesquisas Clínicas LTDA Brasilia, Brasília

30150-221

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

36010-570

Centro Mineiro de Pesquisa - CMiP, Juiz de Fora

80030-110

Centro de Estudos em Terapias Inovadoras, Curitiba

90480-000

LMK Servicos Medicos SS, Porto Alegre

G9A 3X2

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

09117

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

264 43

Olympion General Clinic, Kato Sychena Patras

115 21

Naval Hospital of Athens, Athens

115 27

Laiko General Hospital of Athens, Athens

166 73

General Hospital ''Asklepieio Voulas'', Voula

411 10

University General Hospital of Larissa, Larissa

546 36

Euromedica Kianous Stavros, Thessaloniki

00128

Fondazione Policlinico Universitario Campus Bio-Medico, Rome

00168

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS, Rome

00053

San Paolo Hospital Civitavecchia, Civitavecchia RM

455-0018

Chubu Rosai Hospital, Nagoya

457-0866

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

457-8511

Daido Clinic, Nagoya

060-8543

Sapporo Medical University Hospital, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

807-8556

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

663-8501

Hyogo Medical University Hospital, Nishinomiya-Shi

305-8576

University of Tsukuba Hospital, Tsukuba

920-0293

Kanazawa Medical University Hospital, Kahoku

920-8641

Kanazawa University Hospital, Kanazawa

245-8575

National Hospital Organization Yokohama Medical Center, Yokohama

602-8566

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

606-8507

Kyoto University Hospital, Kyoto

852-8501

Nagasaki University Hospital, Nagasaki

857-1165

Sasebo Chuo Hospital, Sasebo-Shi

710-0824

Kurashiki Medical Clinic, Kurashiki-Shi

350-0495

Saitama Medical University Hospital, Iruma-gun

431-3192

Hamamatsu University Hospital, Hamamatsu

113-8603

Nippon Medical School Hospital, Bunkyo-Ku

104-0044

St. Luke's International Hospital, Chuo-Ku

152-8902

Tokyo Medical Center, Meguro-Ku

160-8582

Keio University Hospital, Shinjuku-Ku

173-8610

Nihon University Itabashi Hospital, tabashi City

ZC 44160

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

06100

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

07760

Consultorio de Reumatologia, México

Unknown

Clinstile, S.A. de C.V., México

Queen's Medical Centre, Nottingham

04013

Hogar Clinica San Juan de Dios - Arequipa, Arequipa

Lima 33

Instituto de Ginecologia y Reproduccion - PPDS, Lima

Lima 21

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada, Pueblo Libre

60-693

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

61-397

Prywatna Praktyka Lekarska Pawel Hrycaj, Poznan

60-185

Centrum Medyczne Poznan - PRATIA - PPDS, Skórzewo

30-149

Malopolskie Centrum Kliniczne, Krakow

52-416

Centrum Medyczne Oporow, Wroclaw

54-049

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

20-412

ETG Lublin - PPDS, Lublin

20-607

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

00-215

FutureMeds - Warszawa Centrum - PPDS, Warsaw

00-874

MICS Centrum Medyczne Warszawa - MICS - PPDS, Warsaw

02-172

MTZ Clinical Research Powered by PRATIA - PPDS, Warsaw

02-637

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

02-665

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

03-291

FutureMeds - Targowek - PPDS, Warsaw

05-200

K2J2 Medical Center, Wołomin

82-200

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

85-065

MICS Centrum Medyczne Bydgoszcz, Bydgoszcz

85-168

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

82-300

Ambulatorium Sp z o.o., Elblag

40-081

Centrum Medyczne Katowice - PRATIA - PPDS, Katowice

30-363

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

31-513

Centrum Medyczne PROMED- Olszanska 5G, Krakow

91-363

FutureMeds - Lodz - PPDS, Lodz

60-324

Twoja Przychodnia PCM, Poznan

02-677

ETG Warszawa - PPDS, Warsaw

04-141

WIM-PIB, Centralny Szpital Kliniczny MON, Warsaw

50-556

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

53-034

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

53-673

FutureMeds - Wroclaw - PPDS, Wroclaw

1349-019

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

4990-041

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

1649-035

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

4434-502

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

00917

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

06591

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

08923

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

01009

Hospital Universitario Araba - Txagorritxu, Vitoria-Gasteiz

LU4 0DZ

Luton and Dunstable University Hospital - PPDS, Luton

NW3 2QG

Royal Free Hospital - PPDS, London

LS7 4SA

Chapel Allerton Hospital - PPDS, Leeds

EC1M 6BQ

William Harvey Research Institute - PPDS, London

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

P06 3LY

Queen Alexandra Hospital, Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY