AzTrials
AzTrials

Primary Sjogrens DiseasePhase 3UnityNCT06684847

A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

A Phase 3 study testing Efgartigimod PH20 SC in people with Primary Sjogrens Disease, run by argenx at 303 sites in 39 countries.

Active, not recruiting

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

Official record
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Trial summary

The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Sjogrens Disease
What is being tested?
Efgartigimod PH20 SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
631 participants
Where
303 sitesin 39 countries
Study dates
15 Jan 2025to Jul 2028
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

  • Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
  • Meets the following criteria at screening: fulfilled ACR/EULAR classification criteria 2016 PSjD criteria before screening; clinESSDAI ≥ 6 at screening; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)

Who cannot join

  • Secondary (also referred to as associated) Sjögren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy
  • Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
  • Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion.
  • Use of cyclophosphamide ≤ 24 weeks prior to screening
  • Anti-CD20 or anti-CD19 antibody received < 6 months before screening

Trial locations and contacts

303 sites in 39 countries.

303 sites in 39 countries

United States42 sites

  • Allen Arthritis

    Allen, Texas, 75013

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30318

  • University of Colorado

    Aurora, Colorado, 80045

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21224

  • Accurate Clinical Management

    Baytown, Texas, 77521

  • Novel Research LLC

    Bellaire, Texas, 77401

  • East Penn Rheumatology Associates, P.C.

    Bethlehem, Pennsylvania, 18105

  • St. Luke's Clinic - Rheumatology

    Boise, Idaho, 83702

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center

    Brooklyn, New York, 11201

  • Chicago Clinical Research Institute

    Chicago, Illinois, 60607

  • Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research

    Chicago, Illinois, 60640

  • Chicago Arthritis & Regenerative Medicine

    Chicago, Illinois, 60657

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Precision Comprehensive Clinical Research Solution

    Colleyville, Texas, 76034-5913

  • Samaritan Health Services

    Corvallis, Oregon, 97330

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33309

  • Arizona Arthritis & Rheumatology Research, PLLC

    Fort Worth, Texas, 76109

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Finlay Medical Research Corp

    Greenacres City, Florida, 33647

  • Accurate Clinical Research, Inc.

    Houston, Texas, 77089

  • North Houston Arthritis Center

    Houston, Texas, 77090

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Arizona Arthritis & Rheumatology Research, PLLC

    Irving, Texas, 75039

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida, 32256

  • R and H Clinical Research

    Katy, Texas, 77450

  • Accurate Clinical Research Inc.

    Lake Charles, Louisiana, 70605

  • Life Clinical Trials

    Margate, Florida, 33063

  • Lake Cumberland Rheumatology

    New Albany, Indiana, 47150

  • Greater Chicago Specialty Physicians LLC

    Orland Park, Illinois, 60467

  • Arthritis and Rheumatism Associates

    Rockville, Maryland, 20850

  • One of a Kind Clinical Research Center LLC

    Scottsdale, Arizona, 85258

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Simcare Medical Research LLC

    Sugar Land, Texas, 77478

  • Arizona Arthritis & Rheumatology Research, PLLC

    Sun City, Arizona, 85351

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

  • Arizona Arthritis & Rheumatology Research, PLLC

    Tucson, Arizona, 85748

  • Velocity Clinical Research Waco

    Waco, Texas, 76712

  • Rheumatic Disease Associates, Ltd.

    Willow Grove, Pennsylvania, 19090

  • Arizona Arthritis & Rheumatology Research, PLLC

    Willowbrook, Illinois, 60527

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

China35 sites

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100044

  • Peking University Third Hospital

    Beijing, 100191

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116027

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, 341000

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

  • Jining No.1 People's Hospital

    Jining, Shandong, 272011

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272029

  • Kunming Medical College Affiliated First Hospital

    Kunming, Yun'Nan, 650032

  • Linfen Central Hospital

    Linfen, Shanxi, 041000

  • Linyi People's Hospital

    Linyi, Shandong, 276005

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637001

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi Zhuang, 530021

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

    Shanghai, 200001

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050066

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi’an, Shanxi, 710061

  • Xinxiang Central Hospital

    Xinxiang, Henan, 453000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450008

Other trials in China

Poland32 sites

  • Nova Reuma

    Bialystok, 15-707

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 85-168

  • Centrum Medyczne Intercor Sp. z o.o

    Bydgoszcz, 85-605

  • Centrum Medyczne K2J2

    Częstochowa, 42-202

  • Centrum Medyczne Pratia Czestochowa

    Częstochowa, 42-217

  • Ambulatorium Sp z o o

    Elblag, 82-300

  • FutureMeds Gdynia

    Gdynia, 81-384

  • MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.

    Grodzisk Mazowiecki, 05-825

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Malopolskie Badania Kliniczne

    Krakow, 30-002

  • FutureMeds Krakow

    Krakow, 31-501

  • SOMED CR

    Lodz, 90-368

  • FutureMeds

    Lodz, 91-363

  • Clinical Trials Umed Sp.z o.o

    Lodz, 92-213

  • ETG Lublin

    Lublin, 20-412

  • Reumed Spolka z o.o.

    Lublin, 20-607

  • Provita Profamilia

    Piotrkow Trybunalski, 97-300

  • Pratia Poznan

    Poznan, 60-192

  • NSZOZ Termedica - Centrum Badan Klinicznych

    Poznan, 60-681

  • Clinical Research Center Spółka z

    Poznan, 61-731

  • ETG Siedlce

    Siedlce, 08-110

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

  • ETG JustMed

    Warsaw, 01-696

  • PRATIA S.A. MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172

  • Izabela Inglot Szczebiot

    Warsaw, 02-637

  • Centrum Medyczne Reuma Park

    Warsaw, 02-665

  • FutureMeds

    Warsaw, 03-291

  • REUMA CENTRUM Specjalistyczna Praktyka Lekarska

    Warsaw, 04-305

  • Centrum Medyczne K2J2

    Wołomin, 05-200

  • FutureMeds

    Wroclaw, 53-673

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Japan20 sites

  • St. Luke's International Hospital

    Chūōku, Tokyo-To, 104-8560

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo-To, 173-8610

  • Shimane University Hospital

    Izumo-shi, Shimane, 693-8501

  • Kanazawa Medical University Hospital

    Kahoku-gun, Ishikawa-ken, 920-0293

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • NHO Tokyo Medical Center

    Meguro-ku, Tokyo-To, 152-8902

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • JCHO Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510

  • Hyogo Medical University Hospital

    Nishinomiya-shi, Hyōgo, 663-8501

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Sasebo Chuo Hospital

    Sasebo-shi, Nagasaki, 857-1195

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi, 983-8536

  • Keio University Hospital

    Shinjuku-ku, Tokyo-To, 160-8582

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Mexico17 sites

  • Investigacion y Biomedicina de Chihuahua, Sociedad Civil

    Chihuahua City, 31000

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca, Morelos, 62448

  • Centro de Investigacion de Tratamientos Innovadores de Sinaloa SC

    Culiacán, Sinaloa, 80000

  • Centro de Investigacion y Atencion Integral Durango S.C.

    Durango, 34080

  • Clinica de Investigacion en Reumatologia y Obesidad S.C.

    Guadalajara, Jalisco, 44650

  • Panamerican Clinical Research Mexico S.A. de C.V. Guadalajara

    Guadalajara, Jalisco, 44670

  • Centro de Estudios de Investigacion Basica y Clinica SC

    Guadalajara, Jalisco, 44690

  • Centro de investigacion medica y reumatologia

    Guadalajara, Jalisco, 44950

  • CIMOVA (Consultorio anexo)

    León, Guanajuato, 37000

  • Unidad de Atencion Medica e Investigacion en Salud

    Mérida, Yucatán, 97000

  • Centro de Investigacion en Reumatologia

    Mérida, Yucatán, 97070

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070

  • Clinstile, S.A. de C.V.

    Mexico City, 06700

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

    San Luis Potosí City, 78200

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.

    San Luis Potosí City, 78213

  • CIMAB SA de CV

    Torreón, Coahuila, 27000

Other trials in Mexico

Colombia14 sites

  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

    Barranquilla, 080002

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 080020

  • Clinica de la Costa S.A.S

    Barranquilla, 080020

  • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

    Bogotá, 110221

  • BlueCare S.A.S

    Bogotá, 111211

  • Sociedad de Cirugia de Bogota Hospital de San Jose

    Bogotá, 111411

  • Servimed S.A.S.

    Bucaramanga, 680003

  • IPS Centro Medico Julian Coronel S.A.

    Cali, 760035

  • Servicios De Salud IPS Suramericana S A S Chipichape IPS

    Cali, 760046

  • Preventive Care Ltda

    Chía, 250001

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681004

  • Hospital Pablo Tobon Uribe

    Medellín, 050034

  • Servicios De Salud IPS Suramericana S A S IPS Sura Industriales Medellin

    Medellín, 50021

  • Healthy Medical Center

    Zipaquirá, 250252

Other trials in Colombia

Argentina13 sites

  • STAT Research S.A.

    Buenos Aires, 1023

  • Centro Medico Barrio Parque

    Buenos Aires, 1425

  • Consultorios Reumatologicos Pampa

    Buenos Aires, C1125ABE

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, C1406AGA

  • Centro Medico Arsema

    CABA, Buenos Aires, C1427CCL

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

  • Sanatorio Parque S.A.

    Rosario, Santa Fe Province, S2000DSV

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ

  • Centro de Investigaciones San Miguel

    San Miguel, Buenos Aires, 1663

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigaciones Reumatológicas

    San Miguel de Tucumán, Tucumán Province, T4000BRD

Other trials in Argentina

Spain12 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario de Badajoz

    Badajoz, Badajoz, 06080

  • Sanitas ES Sanitas Hospital CIMA

    Barcelona, Barcelona, 08034

  • Hospital Universitari Vall d'Hebron - VHIR

    Barcelona, Barcelona, 08035

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, 28031

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain, 28040

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Clinica GAIAS Santiago

    Santiago de Compostela, La Coruña, 15702

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Araba

    Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

South Korea8 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • Chonnam National University Hospital

    Gwangju, 61469

  • Soonchunhyang University Seoul Hospital

    Seoul, 04401

  • Asan Medical Center

    Seoul, 05505

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

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

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

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Georgia7 sites

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141

  • Geo Hospitals LLC

    Tbilisi, 0144

  • VIAN

    Tbilisi, 0159

  • MediClub Georgia LLC

    Tbilisi, 0160

  • Clinic on Mtskheta Street

    Tbilisi, 0179

  • First Medical Center

    Tbilisi, 0180

  • Innova LLC

    Tbilisi, 0186

Other trials in Georgia

Chile6 sites

  • CTR Estudios

    Santiago, 7500571

  • Enroll Spa

    Santiago, 7500587

  • BioMedica Research Group

    Santiago, 7500710

  • Centro de Estudios Reumatologicos

    Santiago, 7501126

  • Centro Medico Prosalud

    Santiago, 7510047

  • Clinical Research Chile SpA.

    Valdivia, 5110683

Other trials in Chile

Jordan6 sites

  • The Specialty Hospital Advanced Clinical Center

    Amman, 11194

  • Jordan University Hospital

    Amman, 11942

  • Abdali Hospital

    Amman

  • Istiklal Hospital

    Amman

  • Pharmaceutical research center at Jordan University of Science and Technology

    Irbid, 22110

  • Irbid Specialty Hospital

    Irbid

Other trials in Jordan

Belgium5 sites

  • Erasme Hospital

    Brussels, 1070

  • University Hospital Antwerp

    Edegem, 2650

  • ReumaClinic

    Genk, 3600

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

France5 sites

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, Rhone, 69437

  • Hôpital Saint Joseph

    Marseille, Bouches-du-Rhône, 13008

  • CHR Orléans

    Orléans, Loiret, 45067

  • Hôpital Lariboisière

    Paris, 75010

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75651

Other trials in France

Greece5 sites

  • Euroclinic of Athens

    Athens, 11521

  • NNA Hospital

    Athens, 11521

  • General Hospital of Athens Laiko

    Athens, 11527

  • University General Hospital Attikon

    Chaïdári, 12462

  • General Hospital Papageorgiou

    Thessaloniki, 56403

Other trials in Greece

Hungary5 sites

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem

    Debrecen, 4032

  • Bekes Varmegyei Kozponti Korhaz

    Gyula, 5700

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7632

  • Vita Verum Medical

    Székesfehérvár, 8000

Other trials in Hungary

Slovakia5 sites

  • Artromac

    Košice, 04011

  • MEDMAN s.r.o.

    Martin, 03601

  • MEDMAN

    Martin, 03601

  • Narodny ustav reumatickych chorob

    Piešťany, 92112

  • ALBAMED

    Zvolen, 96001

Other trials in Slovakia

Australia4 sites

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Westmead Hospital

    Sydney, New South Wales, 2145

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Bulgaria4 sites

  • MC Artmed OOD

    Plovdiv, 4002

  • UMHAT "Pulmed" OOD

    Plovdiv, 4002

  • MHAT Dr Ivan Seliminski AD

    Sliven, 8800

  • DCC "Alexandrovska" EOOD

    Sofia, 1431

Other trials in Bulgaria

Germany4 sites

  • HRF II - Hamburger Rheuma Forschungszentrum II

    Hamburg, Free and Hanseatic City of Hamburg, 20095

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Klinikum der Universitaet Muenchen

    Munich, Bavaria, 80336

  • Universitaetsklinikum

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Israel4 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Meir Medical Center

    Kfar Saba, 4428164

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Lebanon4 sites

  • Saint George Hospital University Medical Center

    Beirut, 1100-2807

  • American University of Beirut

    Beirut, 1107 2020

  • Hotel Dieu de France Hospital

    Beirut, 166830

  • Ain Wazein Medical Village

    El Shouf, 678002

Other trials in Lebanon

Philippines4 sites

  • Ospital Ng Makati

    City of Taguig, 1642

  • Manila Doctors Hospital

    Manila, 1000

  • The Medical City

    Ortigas, 1605

  • St. Luke's Medical Center

    Quezon City, 1112

Other trials in Philippines

Portugal4 sites

  • Unidade Local de Saude de Coimbra

    Coimbra, 3000-075

  • Hospital CUF Descobertas

    Lisbon, 1998-018

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

    Ponte de Lima, 4990-041

  • Unidade Local de Saude de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Tunisia4 sites

  • Hopital Habib Thameur

    Montfleury, 1008

  • EPS Hopital Mohamed Taher Maamouri

    Nabeul, 8000

  • Hedi Chaker Hospital

    Sfax, 3029

  • Hospital Farhat Hached

    Sousse, 4000

Other trials in Tunisia

Canada3 sites

  • Applied Medical Informatics Research Inc.

    Montreal, Quebec, H4A 3T2

  • G.R.M.O Groupe De Recherche En Maladie Osseuses Inc

    Québec, G1V 3M7

  • CHUS - Hôtel-Dieu

    Sherbrooke, Quebec, J1G 2E8

Other trials in Canada

Estonia3 sites

  • OÜ Innomedica

    Tallinn, 10117

  • Center for Clinical and Basic Research

    Tallinn, 10128

  • Meditrials

    Tartu, 50708

Other trials in Estonia

Italy3 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Stabilimento Ospedaliero Santa Chiara

    Pisa, 56100

  • Università Campus Bio-Medico di Roma - UOC Reumatologia

    Roma, 00128

Other trials in Italy

Lithuania3 sites

  • Siauliai Republican Hospital

    Šiauliai, LT-76231

  • Inlita, JSC, Center of Santaros Clinical Trials

    Vilnius, LT-08406

  • Vilnius University Hospital

    Vilnius, LT-08661

Other trials in Lithuania

Peru3 sites

  • Clinica El Golf

    Lima

  • Clinica Internacional Sede San Borja

    Lima

  • Hospital Nacional Cayetano Heredia

    Lima

Other trials in Peru

Romania3 sites

  • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

    Brasov, 500283

  • S.C Delta Health Care S.R.L

    Bucharest, 014142

  • SC Aqua Med Consulting SRL

    Constanța, 900612

Other trials in Romania

Turkey (Türkiye)3 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Gazi University Medical Faculty

    Ankara, 06500

  • Karadeniz Technical University Faculty of Medicine

    Trabzon, 61080

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Cannock Chase Hospital

    Cannock, Staffordshire

  • Royal Hallamshire Hospital

    Sheffield, West Midlands, S10 2JF

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Ireland2 sites

  • Clinical Research Ctr

    Dublin, D04 T6F4

  • Respiratory Depart Research

    Dublin, D15X40D

Other trials in Ireland

Netherlands2 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

Saudi Arabia2 sites

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11211

  • King Saud University Medical City

    Riyadh, 11472

Other trials in Saudi Arabia

Serbia2 sites

  • Institute of Rheumatology

    Belgrade, 11000

  • Special Hospital for Rheumatic Diseases

    Novi Sad, 21000

Other trials in Serbia

Austria1 site

  • Rheuma-Zentrum Wien Oberlaa

    Vienna, 1100

Other trials in Austria

Sweden1 site

  • Studieenheten

    Stockholm, 113 61

Other trials in Sweden

About this study

Official title: A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease

The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.

Being tested
Efgartigimod PH20 SC, Placebo PH20 SC

What participants receive

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

  • Efgartigimod PH20 SCBiological

    subcutaneous efgartigimod PH20 SC given by prefilled syringe

  • Placebo PH20 SCOther

    subcutaneous placebo PH20 SC given by prefilled syringe

Study groups in NCT06684847
Study groupRoleWhat they receive
Double-blinded treatment period: Efgartigimod PH20 SCExperimentalParticipants receiving efgartigimod PH20 SC during the double-blinded treatment period
Receives: Biological: Efgartigimod PH20 SC
Double-blinded treatment period: Placebo PH20 SCPlacebo comparatorParticipants receiving placebo PH20 SC during the double-blinded treatment period
Receives: Other: Placebo PH20 SC
Open-label treatment periodExperimentalParticipants receiving efgartigimod PH20 SC during the open-label treatment period
Receives: Biological: Efgartigimod PH20 SC

What is being measured

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

  1. Change from baseline in clinESSDAI score at week 48

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.

    Measured: Up to 48 weeks

Secondary outcomes (8)

  1. Change from baseline in ESSDAI score at week 48

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).

    Measured: Up to 48 weeks

  2. Proportion of participants with low disease activity (clinESSDAI < 5) at week 48

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.

    Measured: Up to 48 weeks

  3. Proportion of responders on STAR (defined as ≥ 5 points) at week 48

    Sjögren's Tool for Assessing Response ( STAR) has been developed as a composite score to assess the efficacy of treatments for PSjD in 5 domains. Patients are classified as STAR responders when they reach ≥ 5 of 9 points.

    Measured: Up to 48 weeks

  4. Change from baseline in DiSSA joint pain item at week 48

    Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).

    Measured: Up to 48 weeks

  5. Change from baseline in DiSSA total score at week 48

    Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).

    Measured: Up to 48 weeks

  6. Change from baseline in DiSSA sicca domain at week 48

    Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).

    Measured: Up to 48 weeks

  7. Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).

    Measured: Up to 48 weeks

  8. Change from baseline in clinESSDAI score at week 24

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.

    Measured: Up to 24 weeks

Timeline

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

  1. First posted12 Nov 2024
  2. Study start15 Jan 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2028 (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
631 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684847
Sponsor's protocol ID
ARGX-113-2306
Other IDs
2024-516609-22-00
Acronym
Unity
Status last verified
Apr 2026
First submitted
10 Nov 2024
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Efgartigimod PH20 SC in people with Primary Sjogrens Disease, run by argenx at 303 sites in 39 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 2 inclusion and 5 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 303 sites in United States, China, Poland, Japan, Mexico and 34 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 clinESSDAI score at week 48 (time frame: Up to 48 weeks). 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 NCT06684847.

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 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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