AzTrials
AzTrials

Sjogren's SyndromePhase 3NCT06104124

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

A Phase 3 study testing Dazodalibep in people with Sjogren's Syndrome, run by Amgen at 206 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sjogren's Syndrome
What is being tested?
Dazodalibep
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
651 participants
Where
206 sitesin 26 countries
Study dates
24 Jan 2024to 17 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
  • Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.
  • Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

Who cannot join

  • Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  • Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
  • Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that 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.
  • Individuals who have a positive test for hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.
  • Active TB or untreated (per local guidelines) latent TB
  • Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
Show all 9Show fewer
  • Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
  • Last administration of experimental or investigational biologic or oral agents < 6 months prior to screening.
  • Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening.

Trial locations and contacts

206 sites in 26 countries.

206 sites in 26 countries

United States37 sites

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124-1601

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

    Augusta, Georgia, 30912-0004

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

    Austin, Texas, 78745-1470

  • Arizona Arthritis & Rheumatology Associates - Avondale

    Avondale, Arizona, 85392

  • Accurate Clinical Management-Baytown

    Baytown, Texas, 77521

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801-2805

  • Overlake Arthritis & Osteoporosis Center

    Bellevue, Washington, 98004-3016

  • Massachusetts General Hospital (MGH) - Rheumatology Associates

    Boston, Massachusetts, 02114-2621

  • Bradenton Research Center Inc

    Bradenton, Florida, 34205-1704

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

    Brooklyn, New York, 11201-5501

  • Arizona Research Clinic PLLC

    Chandler, Arizona, 85225-2915

  • Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 801 E Morehead St

    Charlotte, North Carolina, 28202

  • Clinical Research of West Florida Inc - Clearwater

    Clearwater, Florida, 33765-2616

  • Duke Early Phase Clinical Research Unit - PPDS

    Durham, North Carolina, 27710-0001

  • Cedar Health Research - Arlington - PPDS

    Euless, Texas, 76040

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

    Flagstaff, Arizona, 86001-6299

  • Tekton Research, LLC - 2121 E Harmony Rd - PPDS

    Fort Collins, Colorado, 80528-3404

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

    Gilbert, Arizona, 85297-7338

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

    Glendale, Arizona, 85306-9800

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-0001

  • Kansas City Physician Partners-8350 N Saint Clair Ave

    Kansas City, Missouri, 64151-5100

  • R & H Clinical Research - Katy - 1531 Westborough Dr

    Katy, Texas, 77449

  • UCSD Altman Clinical and Translational Research Institute Building

    La Jolla, California, 92037-1337

  • Valley Arthritis Center

    McAllen, Texas, 78501

  • Murfreesboro Medical Clinic Westlawn

    Murfreesboro, Tennessee, 37128

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

    Saint Clair Shores, Michigan, 48081

  • Onsite Clinical Solutions, LLC - Salisbury

    Salisbury, North Carolina, 28144

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

    San Antonio, Texas, 78229-3901

  • Low Country Rheumatology PA-Summerville

    Summerville, South Carolina, 29486-7887

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida, 33321-2956

  • BayCare Medical Group

    Tampa, Florida, 33614-7101

  • University of Toledo Medical Center

    Toledo, Ohio, 43614-2595

  • DM Clinical Research - Migraine and COPD - PPDS

    Tomball, Texas, 77375

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

    Tucson, Arizona, 85704-1140

  • Inland Rheumatology Clinical Trials Incorporated

    Upland, California, 91786-4951

  • STAT Research-600 Aviator Ct

    Vandalia, Ohio, 45377-9474

  • Arthritis, Rheumatic & Bone Disease Associates - Voorhees

    Voorhees Township, New Jersey, 08043-4509

Other trials in United States

Poland28 sites

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Medyczne Pratia Katowice - PPDS

    Katowice, 40-081

  • Malopolskie Centrum Kliniczne

    Krakow, Lesser Poland Voivodeship, 30-149

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

    Krakow, 30-363

  • Centrum Medyczne PROMED- Olszanska 5G

    Krakow, 31-513

  • FutureMeds - Lodz - PPDS

    Lodz, 91-363

  • ETG Lublin - PPDS

    Lublin, Lublin Voivodeship, 20-412

  • Reumed Sp. z o.o.

    Lublin, Lublin Voivodeship, 20-607

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

    Malbork, Pomeranian Voivodeship, 82-200

  • Pratia Poznan - PPDS

    Poznan, Greater Poland Voivodeship, 60-192

  • Med-Polonia Sp. z o.o.

    Poznan, Greater Poland Voivodeship, 60-693

  • Prywatna Praktyka Lekarska Pawel Hrycaj

    Poznan, Greater Poland Voivodeship, 61-397

  • Twoja Przychodnia PCM

    Poznan, 60-324

  • FutureMeds - Warszawa Centrum - PPDS

    Warsaw, Masovian Voivodeship, 00-215

  • MICS Centrum Medyczne Warszawa, Wronia - MICS

    Warsaw, Masovian Voivodeship, 00-874

  • MTZ Clinical Research Powered by PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 02-172

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

    Warsaw, Masovian Voivodeship, 02-637

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, Masovian Voivodeship, 02-665

  • FutureMeds - Targowek - PPDS

    Warsaw, Masovian Voivodeship, 03-291

  • ETG Warszawa - PPDS

    Warsaw, 02-677

  • WIM-PIB, Centralny Szpital Kliniczny MON

    Warsaw, 04-141

  • K2J2 Medical Center

    Wołomin, Masovian Voivodeship, 05-200

  • Centrum Medyczne Oporow

    Wroclaw, Lower Silesian Voivodeship, 52-416

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

    Wroclaw, Lower Silesian Voivodeship, 54-049

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

    Wroclaw, 50-556

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

    Wroclaw, 53-034

  • FutureMeds - Wroclaw - PPDS

    Wroclaw, 53-673

Other trials in Poland

Japan23 sites

  • Nippon Medical School Hospital

    Bunkyo-Ku, Tokyo, 113-8603

  • St. Luke's International Hospital

    Chuo-Ku, Tokyo, 104-0044

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Saitama Medical University Hospital

    Iruma-gun, Saitama, 350-0495

  • Kanazawa Medical University Hospital

    Kahoku, Ishikawa-ken, 920-0293

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kita Kyushu-shi, Hukuoka, 807-8556

  • Kurashiki Medical Clinic

    Kurashiki-Shi, Okayama-ken, 710-0824

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, Kyôto, 602-8566

  • Kyoto University Hospital

    Kyoto, Kyôto, 606-8507

  • Tokyo Medical Center

    Meguro-Ku, Tokyo, 152-8902

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Chubu Rosai Hospital

    Nagoya, Aiti, 455-0018

  • Japan Community Health Care Organization (JCHO) Chukyo Hospital

    Nagoya, Aiti, 457-0866

  • Daido Clinic

    Nagoya, Aiti, 457-8511

  • Hyogo Medical University Hospital

    Nishinomiya-Shi, Hyôgo, 663-8501

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô, 060-8543

  • Hokkaido University Hospital

    Sapporo, Hokkaidô, 060-8648

  • Sasebo Chuo Hospital

    Sasebo-Shi, Nagasaki, 857-1165

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • National Hospital Organization Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

Argentina17 sites

  • Hospital General de Agudos Dr. José María Ramos Mejia

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1121ADC

  • Expertia S.A- Mautalén Salud e Investigación

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1128AAF

  • Centro Privado de Medicina Familiar

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1417

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP

  • DOM Centro de Reumatología

    Buenos Aires, C1111AAH

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    Buenos Aires, C1406AGA

  • Centro Medico Arsema

    Buenos Aires, C1427CCL

  • Sanatorio Agote - Swiss Medical Group - PPDS

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425EOE

  • Sanatorio Allende S.A

    Córdoba, Córdoba Province, X5000JHGQ

  • Framingham Centro Médico

    La Plata, Buenos Aires, B1900

  • Instituto CER S.A.

    Quilmes, Buenos Aires, B1878DVB

  • Instituto de Investigaciones Clinicas Quilmes SRL

    Quilmes, Buenos Aires, B1878GEG

  • MR Medicina Reumatologica

    San Fernando, Buenos Aires, B1646GHP

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

    San Juan, J5400DIL

  • Centro de Investigaciones Médicas Tucumán - PPDS

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Centro de Investigaciones Reumatológicas

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Clínica Mayo de U.M.C.B. S.R.L

    San Miguel de Tucumán, Tucumán Province, T4000IHE

Other trials in Argentina

Mexico14 sites

  • Centro de Estudios de Investigacion Basica Y Clinica SC

    Guadalajara, Jalisco, 44690

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

    Guadalajara, Jalisco, ZC 44160

  • Centro de Investigacion Farmacologica Del Bajio Sc

    León, 37160

  • Unidad de Atención Médica e Investigación en Salud

    Mérida, Yucatán, 97070

  • Centro de Investigación en Artritis y Osteoporosis - PPDS

    Mexicali, Estado de Baja California, 21200

  • Consultorio de Reumatologia

    México, 07760

  • Clinstile, S.A. de C.V.

    México

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

    Mexico City, Mexico City, 06100

  • Hospital Universitario Dr. Jose Eleuterio González

    Monterrey, Nuevo León, 64460

  • Oaxaca Site Management Organization - Clinic - OSMO - PPDS

    Oaxaca City, 68000

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

    Parques de San Felipe, Chihuahua, 31203

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

    Saltillo, Coahuila, 25279

  • Centro de Investigación y Tratamiento Reumatológico S.C

    San Miguel Chapultepec, Mexico City, 11850

  • CIMAB SA de CV

    Torreón Centro, Coahuila, 27000

Other trials in Mexico

Italy10 sites

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

    Catania, Sicily, 95121

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

    Pisa, Tuscany, 56126

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

    Reggio Emilia, Emilia-Romagna, 42121

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Rome, Lazio, 00128

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Rome, Lazio, 00168

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

    Turin, Piedmont, 10126

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

    Udine, Friuli Venezia Giulia, 33100

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Veneto, 37134

Other trials in Italy

Spain9 sites

  • Hospital Universitario de Basurto

    Bilbao, 48013

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, Córdoba, 14004

  • Hospital Universitario Infanta Leonor

    Madrid, 28032

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional Universitario de Malaga - Hospital Civil

    Málaga, Málaga, 29009

  • Fundacio Hospital de l'Esperit Sant

    Santa Coloma de Gramenet(Barcelona), 08923

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

  • Hospital Nuestra Señora de Valme

    Seville, 41014

Other trials in Spain

Peru7 sites

  • Hogar Clinica San Juan de Dios - Arequipa

    Arequipa, 04013

  • Hospital Militar Central Luis Arias Schereiber

    Lima, 11

  • Clínica Internacional San Borja-Avenida Guardia Civil 385

    Lima, 15001

  • Instituto de Ginecologia y Reproduccion - PPDS

    Lima, Lima 33

  • Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada

    Pueblo Libre, Lima 21

  • Clinica San Juan Bautista

    San Juan de Lurigancho, Lima region, 15431

  • Clinica San Antonio S.A.C

    Trujillo, La Libertad, 13008

Other trials in Peru

Serbia6 sites

  • Institute of Rheumatology - PPDS

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • University Clinical Center of Serbia - Pasterova 2 - PPDS

    Belgrade, 11000

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Centre of Vojvodina

    Novi Sad, 21000

  • Special Hospital For Rheumatic Diseases Novi Sad

    Novi Sad, 21000

Other trials in Serbia

Brazil5 sites

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

    Belo Horizonte, Minas Gerais, 30150-221

  • AES - AS - L2IP - Instituto de Pesquisas Clínicas LTDA Brasilia

    Brasília, Federal District, 70200-730

  • Centro de Estudos em Terapias Inovadoras

    Curitiba, Paraná, 80030-110

  • LMK Servicos Medicos SS

    Porto Alegre, Rio Grande do Sul, 90480-000

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

    Salvador, Estado de Bahia, 40150-150

Other trials in Brazil

Chile5 sites

  • Enroll SpA - Dr. Manuel Barros Borgono - PPDS

    Providencia, Región-MetropolitanadeSantiago, 7500587

  • BIOCINETIC Ltda

    Santiago, Región-MetropolitanadeSantiago, 8320000

  • Centro de especialidades médicas Vanguardia

    Temuco, Araucania, 4780000

  • Clinical Research Chile SpA - PPDS

    Valdivia, Los Ríos Region, 5110683

  • Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

    Viña del Mar, Valparaiso, 2520000

Other trials in Chile

France5 sites

  • CHU de Bordeaux - Hôpital Saint-André

    Bordeaux, 33000

  • CHU de Brest - Hôpital La Cavale Blanche

    Brest, 29609

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

  • Hopital Emile Muller

    Mulhouse, Haut-Rhin, 68100

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67200

Other trials in France

Greece5 sites

  • Naval Hospital of Athens

    Athens, Attica, 115 21

  • Laiko General Hospital of Athens

    Athens, Attica, 115 27

  • Olympion General Clinic

    Kato Sychena Patras, Achaïa, 264 43

  • University General Hospital of Larissa

    Larissa, Larisa, 411 10

  • Euromedica Kianous Stavros

    Thessaloniki, 546 36

Other trials in Greece

Croatia4 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • University Hospital of Split-Spinciceva 1

    Split, 21000

  • Clinical Center Zagreb - Oncology - Salata 7 - PPDS

    Zagreb, City of Zagreb, 10000

  • Polyclinic Bonifarm

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Germany4 sites

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

    Bad Doberan, Mecklenburg-Vorpommern, 18209

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

    Chemnitz, 09117

  • Rheumazentrum Greifswald

    Greifswald Hansestadt, Mecklenburg-Vorpommern, 17493

  • MVZ Rheuma

    Hamburg, 20095

Other trials in Germany

Hungary4 sites

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

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, Hajdú-Bihar, 4032

  • Bekes Varmegyei Kozponti Korhaz

    Gyula, Bekes County, 5700

  • Vasarhelyi Sarkanyfu Kft.

    Hódmezővásárhely, Csongrád megye, 6800

Other trials in Hungary

Portugal4 sites

  • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisbon, Lisbon District, 1349-019

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

    Lisbon, 1649-035

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

    Ponte de Lima, Viana do Castelo District, 4990-041

  • ULS de Gaia/Espinho, EPE - Unidade I

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Taiwan4 sites

  • Chang Gung Memorial Hospital, Linkou

    Gui Shan Qu, 333

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Medical University Hospital - PPDS

    Taipei, 11031

Other trials in Taiwan

United Kingdom4 sites

  • Chapel Allerton Hospital - PPDS

    Leeds, West Yorkshire, LS7 4SA

  • William Harvey Research Institute - PPDS

    London, EC1M 6BQ

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Queen Alexandra Hospital

    Portsmouth, P06 3LY

Other trials in United Kingdom

New Zealand3 sites

  • Optimal Clinical Trials Ltd - PPDS

    Auckland, 1003

  • Aotearoa Clinical Trials Trust

    Auckland, 2025

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

    Hamilton, 3214

Other trials in New Zealand

Belgium2 sites

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

Israel2 sites

  • Meir Medical Center

    Kfar Saba, Central District, 44281

  • The Chaim Sheba Medical Center - PPDS

    Ramat Gan, 5262100

Other trials in Israel

Australia1 site

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Canada1 site

  • Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille

    Trois-Rivières, Quebec, G9A 3X2

Other trials in Canada

Puerto Rico1 site

  • GCM Medical Group, PSC -62 Calle Jose Marti

    San Juan, 00917

Other trials in Puerto Rico

South Korea1 site

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

    Seoul, 06591

Other trials in South Korea

About this study

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 Systemic Disease Activity

Primary Objective:

To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity.

Secondary Objectives:

  1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.
  2. To evaluate the safety and tolerability of dazodalibep in participants with SS
Read the detailed description

Acquired from Horizon in 2024.

Being tested
Dazodalibep, Placebo
Keywords
Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity Study Phase: Phase 3, European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI), European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI), European Alliance of Associations for Rheumatology (EULAR)
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DazodalibepDrug

    Also called VIB 4920, MEDI 4920

    IV infusion

  • PlaceboDrug

    IV infusion

Study groups in NCT06104124
Study groupRoleWhat they receive
Dazodalibep Dose 1ExperimentalParticipants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
Receives: Drug: Dazodalibep
Dazodalibep Dose 2ExperimentalParticipants will be administered dose 2 of dazodalibep by IV infusion.
Receives: Drug: Dazodalibep
PlaceboPlacebo comparatorParticipants will be administered placebo by IV infusion.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score

    Measured: At Week 48

Secondary outcomes (13)

  1. Proportion of participants achieving ESSDAI response

    Measured: At Week 48

  2. Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score

    Measured: At Week 48

  3. Change from baseline in ESSPRI dryness domain score

    Measured: At Week 48

  4. Change from baseline in DASPRI dryness domain score

    Measured: At Week 48

  5. Change from baseline in tender and swollen joint counts

    Measured: At Week 48

  6. Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)

    Measured: At Week 48

  7. Change from baseline in ESSDAI score

    Measured: Week 12 and Week 24

  8. Change from baseline in DASPRI total score

    Measured: At Week 48

  9. Change from baseline in ESSPRI total score

    Measured: At Week 48

  10. Change from baseline in total stimulated salivary flow

    Measured: At Week 48

  11. Number of participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: Baseline (Day 1) to Week 56

  12. Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)

    Measured: Up to Week 56

  13. Number of participants With Adverse Events of Special Interest (AESIs)

    Measured: Up to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start24 Jan 2024
  3. Primary completion23 Jul 2026
  4. Study completion17 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
651 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06104124
Sponsor's protocol ID
HZNP-DAZ-301
Other IDs
2023-503904-10-00, 2023
Status last verified
Oct 2026
First submitted
23 Oct 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dazodalibep in people with Sjogren's Syndrome, run by Amgen at 206 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 206 sites in United States, Poland, Japan, Argentina, Mexico and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score (time frame: At Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06104124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in