AzTrials
AzTrials

Sjögren's Syndrome (SS)Phase 3NCT06245408

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

A Phase 3 study testing Dazodalibep in people with Sjögren's Syndrome (SS), run by Amgen at 194 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state 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
Sjögren's Syndrome (SS)
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
434 participants
Where
194 sitesin 26 countries
Study dates
8 Apr 2024to 17 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 SS by meeting the 2016 ACR/EULAR Classification Criteria
  • Have an ESSPRI score of ≥ 5 at screening.
  • Have an ESSDAI score of < 5 at screening.
  • Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
  • Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
  • Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
Show all 12Show fewer
  • Meets all of the following tuberculosis (TB) criteria:
  • No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
  • No signs or symptoms suggestive of active TB from medical history or physical examination.
  • No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
  • Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
  • A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).

Who cannot join

  • Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  • History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
  • Active malignancy or history of malignancy within the last 5 years, except as follows:
  • In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR
  • Cutaneous basal cell carcinoma following presumed curative therapy.
  • Individuals who are pregnant or lactating or planning to become pregnant during the study.
Show all 13Show fewer
  • Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
  • Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, 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, or have been treated for, hepatitis B, hepatitis c or HIV infection.
  • Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization.
  • Individuals with:
  • A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
  • Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening.

Trial locations and contacts

194 sites in 26 countries.

194 sites in 26 countries

United States41 sites

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102-1710

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124-1601

  • Arizona Arthritis & Rheumatology Associates - Avondale

    Avondale, Arizona, 85392

  • Accurate Clinical Management-Baytown

    Baytown, Texas, 77521

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801-2805

  • Tufts Medical Center - Rheumatology Research Office - PPDS

    Boston, Massachusetts, 02111-1552

  • Western Washington Medical Group

    Bothell, Washington, 98021-4418

  • 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, North Carolina, 28207-1100

  • Clinical Research of West Florida Inc - Clearwater

    Clearwater, Florida, 33765-2616

  • Medvin Clinical Research - Covina

    Covina, California, 91723

  • Duke Early Phase Clinical Research Unit - PPDS

    Durham, North Carolina, 27710-0001

  • 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, 80528-3400

  • 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

  • Precision Comprehensive Clinical Research Solutions

    Grapevine, Texas, 76051-3143

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-8500

  • Kansas City Physician Partners-8350 N Saint Clair Ave

    Kansas City, Missouri, 64151-5100

  • R & H Clinical Research-777 S Fry Rd

    Katy, Texas, 77450-2297

  • Texas Arthritis & Rheumatology Associates

    Katy, Texas, 77450

  • UCSD Altman Clinical and Translational Research Institute Building

    La Jolla, California, 92037-1337

  • Valley Arthritis Center

    McAllen, Texas, 78501

  • Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg

    Miamisburg, Ohio, 45342-3585

  • 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

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida, 33321-2956

  • BayCare Medical Group Primary Care and Rheumatology - Tampa

    Tampa, Florida, 33614-7101

  • Advanced Rheumatology of Houston - The Woodlands

    The Woodlands, Texas, 77382

  • 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 - P

    Voorhees Township, New Jersey, 08043-4509

  • Medvin Clinical Research

    Whittier, California, 90602

Other trials in United States

Japan22 sites

  • 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

Poland20 sites

  • 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

  • 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

  • Twoja Przychodnia PCM

    Poznan, 60-324

  • FutureMeds - Warszawa Centrum - PPDS

    Warsaw, Masovian Voivodeship, 00-215

  • MICS Centrum Medyczne Warszawa - MICS - PPDS

    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

  • WIM-PIB, Centralny Szpital Kliniczny MON

    Warsaw, 04-141

  • K2J2 Medical Center

    Wołomin, Masovian Voivodeship, 05-200

  • FutureMeds - Wroclaw - PPDS

    Wroclaw, Lower Silesian Voivodeship, 50-088

  • Centrum Medyczne Oporow

    Wroclaw, Lower Silesian Voivodeship, 52-416

  • 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

Other trials in Poland

Argentina15 sites

  • Hospital General de Agudos Dr. José María Ramos Mejia

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1121ADC

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426

  • 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 Guemes

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425EUG

  • Sanatorio Allende S.A

    Córdoba, X5000JHQ

  • 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

  • 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

Mexico11 sites

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

    Americana, Jalisco, 44160

  • Oaxaca Site Management Organization - Clinic - OSMO - PPDS

    Centro, Oaxaca, 68000

  • 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, 6100

  • Hospital Universitario Dr. Jose Eleuterio González

    Mitras Centro, 64460

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

    Monterrey, 64000

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

    Parques de San Felipe, Chihuahua, 31203

  • 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

Spain11 sites

  • Hospital Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario de Basurto

    Bilbao, Vizcaya, 48013

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, Córdoba, 14004

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38330

  • Fundacio Hospital de l'Esperit Sant

    Santa Coloma de Gramenet(Barcelona), 08923

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Hospital Universitario Araba - Txagorritxu

    Vitoria-Gasteiz, Álava, 01009

Other trials in Spain

Italy10 sites

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

    Catania, 95121

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, Piedmont, 28100

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

    Pisa, 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

  • 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

Peru8 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 Peruano del Hueso y la Articulacion S.A.C.

    Lima, 15046

  • 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

Croatia5 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

  • Clinical Hospital Sveti Duh

    Zagreb, City of Zagreb, 10000

  • Polyclinic Bonifarm

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

France5 sites

  • CHU de Bordeaux - Hôpital Saint-André

    Bordeaux, 33000

  • CHU de Brest - Hôpital La Cavale Blanche

    Brest, 29609

  • Hopital Emile Muller

    Mulhouse, 68100

  • AP-HP - Hôpital Saint Antoine

    Paris, 75571

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67200

Other trials in France

Germany5 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

  • University Clinic Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

Brazil4 sites

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

    Belo Horizonte, Minas Gerais, 30150-221

  • 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

Chile4 sites

  • BIOCINETIC Ltda

    Peñalolén, Región-MetropolitanadeSantiago, 7910000

  • Enroll SpA - Dr. Manuel Barros Borgono - PPDS

    Santiago, Región-MetropolitanadeSantiago

  • Clinical Research Chile SpA - PPDS

    Valdivia, Los Ríos Region, 5090000

  • Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

    Viña del Mar, Valparaiso, 2520000

Other trials in Chile

Portugal4 sites

  • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisbon, 1300-344

  • 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, 4990-041

  • ULS de Gaia/Espinho, EPE - Unidade I

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Taiwan4 sites

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 407

  • Taipei Medical University Hospital - PPDS

    Taipei, 110

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 333

Other trials in Taiwan

Greece3 sites

  • Laiko General Hospital of Athens

    Athens, Attica, 115 27

  • University General Hospital of Larissa

    Larissa, Larisa, 411 10

  • Euromedica Kianous Stavros

    Thessaloniki, 546 36

Other trials in Greece

Hungary3 sites

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

    Budapest, 1097

  • Bekes Varmegyei Kozponti Korhaz

    Gyula, Bekes County, 5700

  • Vasarhelyi Sarkanyfu Kft.

    Hódmezővásárhely, Csongrád megye, 6800

Other trials in Hungary

New Zealand3 sites

  • Optimal Clinical Trials Ltd - PPDS

    Auckland, North Island, 1003

  • Aotearoa Clinical Trials Trust

    Auckland, 2025

  • Waikato Hospital

    Hamilton, 3214

Other trials in New Zealand

Slovenia2 sites

  • University Medical Centre Ljubljana-Vodnikova cesta 62

    Ljubljana, 1000

  • University Clinical Centre Maribor

    Maribor, 2000

Other trials in Slovenia

South Korea2 sites

  • Chonnam National University Hospital

    Gwangju, 61469

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

    Seoul, 06591

Other trials in South Korea

United Kingdom2 sites

  • Chapel Allerton Hospital - PPDS

    Leeds, LS7 4SA

  • William Harvey Research Institute - PPDS

    London, EC1M 6BQ

Other trials in United Kingdom

Australia1 site

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Belgium1 site

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

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

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 Symptom State (HZNP-DAZ-303)

Primary Objective:

To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state

Secondary Objectives:

  1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS.
  2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS
  3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Read the detailed description

Acquired from Horizon in 2024.

Being tested
Dazodalibep, Placebo
Keywords
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, MEDI4920

    IV infusion

  • PlaceboDrug

    IV infusion

Study groups in NCT06245408
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 ESSPRI score

    Measured: At Week 48

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

    Measured: At week 48

Secondary outcomes (16)

  1. Proportion of participants achieving meaningful improvement in DASPRI

    Measured: At Week 48

  2. Proportion of participants achieving ESSPRI [1.5] response

    Measured: At Week 48

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

    Measured: At Week 48

  4. Change from baseline in DASPRI Dryness

    Measured: At Week 48

  5. Change from baseline in ESSPRI Dryness

    Measured: At Week 48

  6. Change from baseline in DASPRI Pain

    Measured: At Week 48

  7. Change from baseline in ESSPRI Pain

    Measured: At Week 48

  8. Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score

    Measured: At Week 48

  9. Change from baseline in DASPRI total score

    Measured: At week 12 and week 24

  10. Change from baseline in ESSPRI total score

    Measured: At week 12, Week 24

  11. Change from baseline in DASPRI Fatigue

    Measured: At Week 48

  12. Change from baseline in ESSPRI fatigue domain score

    Measured: At Week 48

  13. Change from baseline in total stimulated salivary flow

    Measured: At Week 48

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

    Measured: Baseline (Day 1) to Week 56

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

    Measured: Baseline (Day 1) to Week 56

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

    Measured: Baseline (Day 1) 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 posted7 Feb 2024
  2. Study start8 Apr 2024
  3. Primary completion22 Oct 2026 (estimated)
  4. Study completion17 Dec 2026 (estimated)

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
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06245408
Sponsor's protocol ID
HZNP-DAZ-303
Status last verified
Dec 2025
First submitted
30 Jan 2024
Last updated
8 Jan 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 Sjögren's Syndrome (SS), run by Amgen at 194 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 12 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in United States, Japan, Poland, 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?

This study is still under way. Results are not available in the source record yet.

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 ESSPRI score (time frame: At Week 48). The study lists 2 primary outcomes in all. 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 NCT06245408.

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 8 Jan 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