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

April 15, 2026 updated by: argenx

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

631

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1406AGA
        • APRILLUS Asistencia e Investigacion
      • Buenos Aires, Argentina, 1023
        • STAT Research S.A.
      • Buenos Aires, Argentina, 1425
        • Centro Medico Barrio Parque
      • Buenos Aires, Argentina, C1125ABE
        • Consultorios Reumatológicos Pampa
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1427CCL
        • Centro Medico Arsema
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Centro de Investigaciones Médicas Mar del Plata
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes
      • San Miguel, Buenos Aires, Argentina, 1663
        • Centro de Investigaciones San Miguel
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000PBJ
        • Instituto CAICI
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Sanatorio Parque S.A.
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro de Investigaciones Medicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000BRD
        • Centro de Investigaciones Reumatológicas
  • Australia
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre Clayton
  • Austria
      • Vienna, Austria, 1100
        • Rheuma-Zentrum Wien Oberlaa
  • Belgium
      • Brussels, Belgium, 1070
        • Erasme hospital
      • Edegem, Belgium, 2650
        • University Hospital Antwerp
      • Genk, Belgium, 3600
        • ReumaClinic
      • Ghent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • MC Artmed OOD
      • Plovdiv, Bulgaria, 4002
        • UMHAT "Pulmed" OOD
      • Sliven, Bulgaria, 8800
        • MHAT Dr Ivan Seliminski AD
      • Sofia, Bulgaria, 1431
        • DCC "Alexandrovska" EOOD
  • Canada
      • Québec, Canada, G1V 3M7
        • G.R.M.O Groupe De Recherche En Maladie Osseuses Inc
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Applied Medical Informatics Research Inc.
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CHUS - Hôtel-Dieu
  • Chile
      • Santiago, Chile, 7500710
        • Biomedica Research Group
      • Santiago, Chile, 7501126
        • Centro de Estudios Reumatologicos
      • Santiago, Chile, 7510047
        • Centro Medico Prosalud
      • Santiago, Chile, 7500571
        • CTR Estudios
      • Santiago, Chile, 7500587
        • Enroll SpA
      • Valdivia, Chile, 5110683
        • Clinical Research Chile SpA.
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University
      • Shanghai, China, 200001
        • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital of Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510280
        • Zhujiang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital
    • Guangxi Zhuang
      • Nanning, Guangxi Zhuang, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • The Affiliated Hospital of Guizhou Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050066
        • The Second Hospital of Hebei Medical University
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Xinxiang, Henan, China, 453000
        • Xinxiang Central Hospital
      • Zhengzhou, Henan, China, 450008
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Huai'an First People's Hospital
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Ganzhou People's Hospital
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
      • Pingxiang, Jiangxi, China, 337055
        • Pingxiang People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • The Second Hospital of Dalian Medical University
    • Shandong
      • Jining, Shandong, China, 272011
        • Jining No.1 People's Hospital
      • Jining, Shandong, China, 272029
        • Affiliated Hospital of Jining Medical University
      • Linyi, Shandong, China, 276005
        • Linyi People's Hospital
    • Shanxi
      • Linfen, Shanxi, China, 041000
        • Linfen Central Hospital
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Bethune Hospital
      • Xi’an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xian Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital
      • Nanchong, Sichuan, China, 637001
        • Affiliated Hospital of North Sichuan Medical College
    • Yun'Nan
      • Kunming, Yun'Nan, China, 650032
        • Kunming Medical College Affiliated First Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Colombia
      • Barranquilla, Colombia, 080020
        • Centro de Investigacion Medico Asistencial S.A.S
      • Barranquilla, Colombia, 080020
        • Clínica de la Costa S.A.S
      • Barranquilla, Colombia, 080002
        • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
      • Bogotá, Colombia, 110221
        • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
      • Bogotá, Colombia, 111211
        • BlueCare S.A.S
      • Bogotá, Colombia, 111411
        • Sociedad de Cirugia de Bogota Hospital de San Jose
      • Bucaramanga, Colombia, 680003
        • Servimed S.A.S.
      • Cali, Colombia, 760035
        • IPS Centro Medico Julian Coronel S.A.
      • Cali, Colombia, 760046
        • Servicios De Salud IPS Suramericana S A S Chipichape IPS
      • Chía, Colombia, 250001
        • Preventive Care Ltda
      • Floridablanca, Colombia, 681004
        • Fundacion Oftalmologica de Santander - Foscal
      • Medellín, Colombia, 050034
        • Hospital Pablo Tobon Uribe
      • Medellín, Colombia, 50021
        • Servicios De Salud IPS Suramericana S A S IPS Sura Industriales Medellin
      • Zipaquirá, Colombia, 250252
        • Healthy Medical Center
  • Estonia
      • Tallinn, Estonia, 10117
        • OÜ Innomedica
      • Tallinn, Estonia, 10128
        • Center for Clinical and Basic Research
      • Tartu, Estonia, 50708
        • Meditrials
  • France
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75651
        • Groupe Hospitalier Pitie-Salpetriere
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13008
        • Hôpital Saint Joseph
    • Loiret
      • Orléans, Loiret, France, 45067
        • CHR Orléans
    • Rhone
      • Lyon, Rhone, France, 69437
        • Hopital Edouard Herriot - CHU Lyon
  • Georgia
      • Tbilisi, Georgia, 0141
        • The First University Clinic of Tbilisi State Medical University
      • Tbilisi, Georgia, 0180
        • First Medical Center
      • Tbilisi, Georgia, 0179
        • Clinic on Mtskheta Street
      • Tbilisi, Georgia, 0144
        • Geo Hospitals LLC
      • Tbilisi, Georgia, 0159
        • VIAN
      • Tbilisi, Georgia, 0160
        • MediClub Georgia LLC
      • Tbilisi, Georgia, 0186
        • Innova LLC
  • Germany
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Klinikum der Universitaet Muenchen
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20095
        • HRF II - Hamburger Rheuma Forschungszentrum II
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens Laiko
      • Athens, Greece, 11521
        • Euroclinic of Athens
      • Athens, Greece, 11521
        • NNA Hospital
      • Chaïdári, Greece, 12462
        • University General Hospital Attikon
      • Thessaloniki, Greece, 56403
        • General Hospital Papageorgiou
  • Hungary
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem
      • Gyula, Hungary, 5700
        • Békés Vármegyei Központi Kórház
      • Pécs, Hungary, 7632
        • Pécsi Tudományegyetem Klinikai Központ
      • Székesfehérvár, Hungary, 8000
        • Vita Verum Medical
  • Ireland
      • Dublin, Ireland, D04 T6F4
        • Clinical Research Ctr
      • Dublin, Ireland, D15X40D
        • Respiratory Depart Research
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Pisa, Italy, 56100
        • Stabilimento Ospedaliero Santa Chiara
      • Roma, Italy, 00128
        • Università Campus Bio-Medico di Roma - UOC Reumatologia
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8510
        • JCHO Chukyo Hospital
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Nishinomiya-shi, Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
    • Ishikawa-ken
      • Kahoku-gun, Ishikawa-ken, Japan, 920-0293
        • Kanazawa Medical University Hospital
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Kagawa University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Sendai, Miyagi, Japan, 983-8536
        • Tohoku Medical and Pharmaceutical University Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Sasebo-shi, Nagasaki, Japan, 857-1195
        • Sasebo Chuo Hospital
    • Osaka
      • Osaka, Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital
    • Shimane
      • Izumo-shi, Shimane, Japan, 693-8501
        • Shimane University Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University School of Medicine, University Hospital
    • Tokyo-To
      • Chūōku, Tokyo-To, Japan, 104-8560
        • St. Luke's International Hospital
      • Itabashi-ku, Tokyo-To, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Meguro-ku, Tokyo-To, Japan, 152-8902
        • NHO Tokyo Medical Center
      • Shinjuku-ku, Tokyo-To, Japan, 160-8582
        • Keio University Hospital
  • Jordan
      • Amman, Jordan, 11942
        • Jordan University Hospital
      • Amman, Jordan
        • Abdali Hospital
      • Amman, Jordan, 11194
        • The Specialty Hospital Advanced Clinical Center
      • Amman, Jordan
        • Istiklal Hospital
      • Irbid, Jordan
        • Irbid Specialty Hospital
      • Irbid, Jordan, 22110
        • Pharmaceutical research center at Jordan University of Science and Technology
  • Lebanon
      • Beirut, Lebanon, 166830
        • Hotel Dieu de France Hospital
      • Beirut, Lebanon, 1107 2020
        • American University of Beirut
      • Beirut, Lebanon, 1100-2807
        • Saint George Hospital University Medical Center
      • El Shouf, Lebanon, 678002
        • Ain Wazein Medical Village
  • Lithuania
      • Vilnius, Lithuania, LT-08406
        • Inlita, JSC, Center of Santaros Clinical Trials
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital
      • Šiauliai, Lithuania, LT-76231
        • Siauliai Republican Hospital
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Investigacion y Biomedicina de Chihuahua, Sociedad Civil
      • Durango, Mexico, 34080
        • Centro de Investigacion y Atencion Integral Durango S.C.
      • Mexico City, Mexico, 06700
        • Clinstile, S.A. de C.V.
      • San Luis Potosí City, Mexico, 78200
        • Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
      • San Luis Potosí City, Mexico, 78213
        • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
    • Coahuila
      • Torreón, Coahuila, Mexico, 27000
        • CIMAB SA de CV
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • CIMOVA (Consultorio anexo)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C.
      • Guadalajara, Jalisco, Mexico, 44690
        • Centro de Estudios de Investigacion Basica Y Clinica SC
      • Guadalajara, Jalisco, Mexico, 44950
        • Centro de investigacion medica y reumatologia
      • Guadalajara, Jalisco, Mexico, 44670
        • Panamerican Clinical Research Mexico S.A. de C.V. Guadalajara
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62448
        • Consultorio Privado Dr. Miguel Cortes Hernandez
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio González
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80000
        • Centro de Investigacion de Tratamientos Innovadores de Sinaloa SC
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Unidad de Atención Médica e Investigación en Salud
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care & Research SA de CV
      • Mérida, Yucatán, Mexico, 97070
        • Centro de Investigacion en Reumatologia
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
  • Peru
      • Lima, Peru
        • Clinica Internacional Sede San Borja
      • Lima, Peru
        • Hospital Nacional Cayetano Heredia
      • Lima, Peru
        • Clinica El Golf
  • Philippines
      • City of Taguig, Philippines, 1642
        • Ospital Ng Makati
      • Manila, Philippines, 1000
        • Manila Doctors Hospital
      • Ortigas, Philippines, 1605
        • The Medical City
      • Quezon City, Philippines, 1112
        • St. Luke's Medical Center
  • Poland
      • Bialystok, Poland, 15-707
        • Nova Reuma
      • Bydgoszcz, Poland, 85-065
        • MICS Centrum Medyczne Bydgoszcz
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im.dr J. Biziela
      • Bydgoszcz, Poland, 85-605
        • Centrum Medyczne Intercor Sp. z o.o
      • Częstochowa, Poland, 42-217
        • Centrum Medyczne Pratia Częstochowa
      • Częstochowa, Poland, 42-202
        • Centrum Medyczne K2J2
      • Elblag, Poland, 82-300
        • Ambulatorium Sp z o o
      • Gdynia, Poland, 81-384
        • FutureMeds Gdynia
      • Grodzisk Mazowiecki, Poland, 05-825
        • MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Krakow, Poland, 30-002
        • Malopolskie Badania Kliniczne
      • Krakow, Poland, 31-501
        • FutureMeds Krakow
      • Lodz, Poland, 90-368
        • SOMED CR
      • Lodz, Poland, 91-363
        • FutureMeds
      • Lodz, Poland, 92-213
        • Clinical Trials Umed Sp.z o.o
      • Lublin, Poland, 20-412
        • ETG Lublin
      • Lublin, Poland, 20-607
        • Reumed Spolka z o.o.
      • Piotrkow Trybunalski, Poland, 97-300
        • Provita Profamilia
      • Poznan, Poland, 60-192
        • Pratia Poznan
      • Poznan, Poland, 60-681
        • NSZOZ Termedica - Centrum Badan Klinicznych
      • Poznan, Poland, 61-731
        • Clinical Research Center Spółka z
      • Siedlce, Poland, 08-110
        • ETG Siedlce
      • Warsaw, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
      • Warsaw, Poland, 02-665
        • Centrum Medyczne Reuma Park
      • Warsaw, Poland, 01-696
        • ETG JustMed
      • Warsaw, Poland, 02-172
        • PRATIA S.A. MTZ Clinical Research Powered by Pratia
      • Warsaw, Poland, 02-637
        • Izabela Inglot Szczebiot
      • Warsaw, Poland, 03-291
        • FutureMeds
      • Warsaw, Poland, 04-305
        • REUMA CENTRUM Specjalistyczna Praktyka Lekarska
      • Wołomin, Poland, 05-200
        • Centrum Medyczne K2J2
      • Wroclaw, Poland, 53-673
        • FutureMeds
      • Zamość, Poland, 22-400
        • ETG Zamosc
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Unidade Local de Saude de Coimbra
      • Lisbon, Portugal, 1998-018
        • Hospital Cuf Descobertas
      • Ponte de Lima, Portugal, 4990-041
        • Hospital Conde de Bertiandos - Ponte de Lima (Unidade Local do Alto Minho, EPE)
      • Vila Nova de Gaia, Portugal, 4434-502
        • Unidade Local de Saude de Gaia/Espinho, E.P.E.
  • Romania
      • Brasov, Romania, 500283
        • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
      • Bucharest, Romania, 014142
        • S.C Delta Health Care S.R.L
      • Constanța, Romania, 900612
        • SC Aqua Med Consulting SRL
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Center
      • Riyadh, Saudi Arabia, 11472
        • King Saud University Medical City
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Rheumatology
      • Novi Sad, Serbia, 21000
        • Special Hospital for Rheumatic Diseases
  • Slovakia
      • Košice, Slovakia, 04011
        • Artromac
      • Martin, Slovakia, 03601
        • MEDMAN s.r.o.
      • Martin, Slovakia, 03601
        • MEDMAN
      • Piešťany, Slovakia, 92112
        • Narodny ustav reumatickych chorob
      • Zvolen, Slovakia, 96001
        • ALBAMED
  • South Korea
      • Gwangju, South Korea, 61469
        • Chonnam National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 04401
        • Soonchunhyang University Seoul Hospital
      • Seoul, South Korea, 06973
        • Chung-Ang University Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, South Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Ajou University Hospital
      • Suwon, Gyeonggi-do, South Korea, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario a Coruña
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41010
        • Hospital Quironsalud Infanta Luisa
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Alava
      • Vitoria-Gasteiz, Alava, Spain, 01009
        • Hospital Universitario Araba
    • Badajoz
      • Badajoz, Badajoz, Spain, 06080
        • Hospital Universitario de Badajoz
    • Barcelona
      • Barcelona, Barcelona, Spain, 08034
        • Sanitas ES Sanitas Hospital CIMA
      • Barcelona, Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron - VHIR
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15702
        • Clínica Gaias Santiago
    • Madrid
      • Madrid, Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
    • Spain
      • Madrid, Spain, Spain, 28040
        • Hospital Universitario Fundación Jiménez Díaz
  • Sweden
      • Stockholm, Sweden, 113 61
        • Studieenheten
  • Tunisia
      • Montfleury, Tunisia, 1008
        • Hopital Habib Thameur
      • Nabeul, Tunisia, 8000
        • EPS Hopital Mohamed Taher Maamouri
      • Sfax, Tunisia, 3029
        • Hedi Chaker Hospital
      • Sousse, Tunisia, 4000
        • Hospital Farhat Hached
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06500
        • Gazi University Medical Faculty
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Technical University Faculty of Medicine
  • United Kingdom
      • Cannock, United Kingdom, Staffordshire
        • Cannock Chase Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • West Midlands
      • Sheffield, West Midlands, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • One of a Kind Clinical Research Center LLC
      • Sun City, Arizona, United States, 85351
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Tucson, Arizona, United States, 85748
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Fort Lauderdale, Florida, United States, 33309
        • Centre for Rheumatology, Immunology and Arthritis
      • Greenacres City, Florida, United States, 33647
        • Finlay Medical Research Corp
      • Jacksonville, Florida, United States, 32256
        • University of Florida College of Medicine Jacksonville
      • Margate, Florida, United States, 33063
        • Life Clinical Trials
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida, Inc.
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Healthcare, Inc.
    • Idaho
      • Boise, Idaho, United States, 83702
        • St. Luke's Clinic - Rheumatology
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Institute
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
      • Chicago, Illinois, United States, 60657
        • Chicago Arthritis & Regenerative Medicine
      • Orland Park, Illinois, United States, 60467
        • Greater Chicago Specialty Physicians LLC
      • Willowbrook, Illinois, United States, 60527
        • Arizona Arthritis & Rheumatology Research, PLLC
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Lake Cumberland Rheumatology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Accurate Clinical Research Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • The Johns Hopkins Hospital
      • Rockville, Maryland, United States, 20850
        • Arthritis and Rheumatism Associates
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Brooklyn, New York, United States, 11201
        • Joseph S. and Diane H. Steinberg Ambulatory Care Center
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Health Services
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18105
        • East Penn Rheumatology Associates, P.C.
      • Willow Grove, Pennsylvania, United States, 19090
        • Rheumatic Disease Associates, Ltd.
    • Texas
      • Allen, Texas, United States, 75013
        • Allen Arthritis
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Management
      • Bellaire, Texas, United States, 77401
        • Novel Research LLC
      • Colleyville, Texas, United States, 76034-5913
        • Precision Comprehensive Clinical Research Solution
      • Dallas, Texas, United States, 75235
        • Southwest Family Medicine Associates
      • Fort Worth, Texas, United States, 76109
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research, Inc.
      • Houston, Texas, United States, 77090
        • North Houston Arthritis Center
      • Irving, Texas, United States, 75039
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Katy, Texas, United States, 77450
        • R and H Clinical Research
      • Sugar Land, Texas, United States, 77478
        • Simcare Medical Research LLC
      • Waco, Texas, United States, 76712
        • Velocity Clinical Research Waco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-blinded treatment period: Efgartigimod PH20 SC
Participants receiving efgartigimod PH20 SC during the double-blinded treatment period
Biological: Efgartigimod PH20 SC
subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo Comparator: Double-blinded treatment period: Placebo PH20 SC
Participants receiving placebo PH20 SC during the double-blinded treatment period
Other: Placebo PH20 SC
subcutaneous placebo PH20 SC given by prefilled syringe
Experimental: Open-label treatment period
Participants receiving efgartigimod PH20 SC during the open-label treatment period
Biological: Efgartigimod PH20 SC
subcutaneous efgartigimod PH20 SC given by prefilled syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in clinESSDAI score at week 48
Time Frame: Up to 48 weeks
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.
Up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in ESSDAI score at week 48
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
Proportion of participants with low disease activity (clinESSDAI < 5) at week 48
Time Frame: Up to 48 weeks
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.
Up to 48 weeks
Proportion of responders on STAR (defined as ≥ 5 points) at week 48
Time Frame: Up to 48 weeks
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.
Up to 48 weeks
Change from baseline in DiSSA joint pain item at week 48
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
Change from baseline in DiSSA total score at week 48
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
Change from baseline in DiSSA sicca domain at week 48
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
Change from baseline in clinESSDAI score at week 24
Time Frame: Up to 24 weeks
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.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-2306
  • 2024-516609-22-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Sjogrens Disease

Clinical Trials on Efgartigimod PH20 SC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe