RecruitingPhase 3NCT06684847

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

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


Sponsor

argenx

Enrollment

580 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

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. The maximum study duration for participants in both study parts is approximately 105 weeks.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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

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Interventions

BIOLOGICALEfgartigimod PH20 SC

subcutaneous efgartigimod PH20 SC given by prefilled syringe

OTHERPlacebo PH20 SC

subcutaneous placebo PH20 SC given by prefilled syringe


Locations(304)

One of a Kind Clinical Research Center LLC

Scottsdale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Tucson, Arizona, United States

Providence Medical Foundation

Fullerton, California, United States

Stanford University School of Medicine

Stanford, California, United States

University of Colorado

Aurora, Colorado, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, United States

Finlay Medical Research Corp

Greenacres City, Florida, United States

University of Florida College of Medicine Jacksonville

Jacksonville, Florida, United States

Life Clinical Trials

Margate, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Conquest Research

Winter Park, Florida, United States

Piedmont Healthcare, Inc.

Atlanta, Georgia, United States

St. Luke's Clinic - Rheumatology

Boise, Idaho, United States

Chicago Clinical Research Institute

Chicago, Illinois, United States

Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research

Chicago, Illinois, United States

Chicago Arthritis & Regenerative Medicine

Chicago, Illinois, United States

Greater Chicago Specialty Physicians LLC

Orland Park, Illinois, United States

Arizona Arthritis & Rheumatology Research, PLLC

Willowbrook, Illinois, United States

Lake Cumberland Rheumatology

New Albany, Indiana, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Accurate Clinical Research Inc.

Lake Charles, Louisiana, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Arthritis and Rheumatism Associates

Rockville, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Joseph S. and Diane H. Steinberg Ambulatory Care Center

Brooklyn, New York, United States

Samaritan Health Services

Corvallis, Oregon, United States

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania, United States

Rheumatic Disease Associates, Ltd.

Willow Grove, Pennsylvania, United States

Allen Arthritis

Allen, Texas, United States

Accurate Clinical Management

Baytown, Texas, United States

Novel Research LLC

Bellaire, Texas, United States

Precision Comprehensive Clinical Research Solution

Colleyville, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

Arizona Arthritis & Rheumatology Research, PLLC

Fort Worth, Texas, United States

Accurate Clinical Research, Inc.

Houston, Texas, United States

North Houston Arthritis Center

Houston, Texas, United States

Arizona Arthritis & Rheumatology Research, PLLC

Irving, Texas, United States

R and H Clinical Research

Katy, Texas, United States

Simcare Medical Research LLC

Sugar Land, Texas, United States

Velocity Clinical Research Waco

Waco, Texas, United States

Centro Medico Arsema

CABA, Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

Centro de Investigaciones San Miguel

San Miguel, Buenos Aires, Argentina

Sanatorio Parque S.A.

Rosario, Santa Fe Province, Argentina

Instituto CAICI

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

STAT Research S.A.

Buenos Aires, Argentina

Centro Medico Barrio Parque

Buenos Aires, Argentina

Consultorios Reumatologicos Pampa

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

APRILLUS Asistencia e Investigacion

Buenos Aires, Argentina

Westmead Hospital

Sydney, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Monash Medical Centre Clayton

Clayton, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Australia

Rheuma-Zentrum Wien Oberlaa

Vienna, Austria

Erasme Hospital

Brussels, Belgium

University Hospital Antwerp

Edegem, Belgium

ReumaClinic

Genk, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

MC Artmed OOD

Plovdiv, Bulgaria

UMHAT "Pulmed" OOD

Plovdiv, Bulgaria

MHAT Dr Ivan Seliminski AD

Sliven, Bulgaria

DCC "Alexandrovska" EOOD

Sofia, Bulgaria

Applied Medical Informatics Research Inc.

Montreal, Quebec, Canada

CHUS - Hôtel-Dieu

Sherbrooke, Quebec, Canada

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

Québec, Canada

CTR Estudios

Santiago, Chile

Enroll Spa

Santiago, Chile

BioMedica Research Group

Santiago, Chile

Centro de Estudios Reumatologicos

Santiago, Chile

Centro Medico Prosalud

Santiago, Chile

Clinical Research Chile SpA.

Valdivia, Chile

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi Zhuang, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Xinxiang Central Hospital

Xinxiang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Jining No.1 People's Hospital

Jining, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Linyi People's Hospital

Linyi, Shandong, China

Linfen Central Hospital

Linfen, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Kunming Medical College Affiliated First Hospital

Kunming, Yun'Nan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

Shanghai, China

Huashan Hospital, Fudan University

Shanghai, China

Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

Barranquilla, Colombia

Centro de Investigacion Medico Asistencial S.A.S

Barranquilla, Colombia

Clinica de la Costa S.A.S

Barranquilla, Colombia

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

Bogotá, Colombia

BlueCare S.A.S

Bogotá, Colombia

Sociedad de Cirugia de Bogota Hospital de San Jose

Bogotá, Colombia

Servimed S.A.S.

Bucaramanga, Colombia

IPS Centro Medico Julian Coronel S.A.

Cali, Colombia

Servicios De Salud IPS Suramericana S A S Chipichape IPS

Cali, Colombia

Preventive Care Ltda

Chía, Colombia

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, Colombia

Hospital Pablo Tobon Uribe

Medellín, Colombia

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

Medellín, Colombia

Healthy Medical Center

Zipaquirá, Colombia

OÜ Innomedica

Tallinn, Estonia

Center for Clinical and Basic Research

Tallinn, Estonia

Meditrials

Tartu, Estonia

Hôpital Saint Joseph

Marseille, Bouches-du-Rhône, France

CHR Orléans

Orléans, Loiret, France

Hopital Edouard Herriot - CHU Lyon

Lyon, Rhone, France

Hôpital Lariboisière

Paris, France

Groupe Hospitalier Pitie-Salpetriere

Paris, France

The First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

Geo Hospitals LLC

Tbilisi, Georgia

VIAN

Tbilisi, Georgia

MediClub Georgia LLC

Tbilisi, Georgia

Clinic on Mtskheta Street

Tbilisi, Georgia

First Medical Center

Tbilisi, Georgia

Innova LLC

Tbilisi, Georgia

Universitaetsklinikum

Tübingen, Baden-Wurttemberg, Germany

Klinikum der Universitaet Muenchen

Munich, Bavaria, Germany

HRF II - Hamburger Rheuma Forschungszentrum II

Hamburg, Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Euroclinic of Athens

Athens, Greece

NNA Hospital

Athens, Greece

General Hospital of Athens Laiko

Athens, Greece

University General Hospital Attikon

Chaïdári, Greece

General Hospital Papageorgiou

Thessaloniki, Greece

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, Hungary

Debreceni Egyetem

Debrecen, Hungary

Bekes Varmegyei Kozponti Korhaz

Gyula, Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Vita Verum Medical

Székesfehérvár, Hungary

Clinical Research Ctr

Dublin, Ireland

Respiratory Depart Research

Dublin, Ireland

Barzilai Medical Center

Ashkelon, Israel

The Lady Davis Carmel Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

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

Brescia, Italy

Stabilimento Ospedaliero Santa Chiara

Pisa, Italy

Università Campus Bio-Medico di Roma - UOC Reumatologia

Roma, Italy

JCHO Chukyo Hospital

Nagoya, Aichi-ken, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Medical University Hospital

Nishinomiya-shi, Hyōgo, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Kanazawa Medical University Hospital

Kahoku-gun, Ishikawa-ken, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Sasebo Chuo Hospital

Sasebo-shi, Nagasaki, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Shimane University Hospital

Izumo-shi, Shimane, Japan

Hamamatsu University School of Medicine, University Hospital

Hamamatsu, Shizuoka, Japan

St. Luke's International Hospital

Chūōku, Tokyo-To, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo-To, Japan

NHO Tokyo Medical Center

Meguro-ku, Tokyo-To, Japan

Keio University Hospital

Shinjuku-ku, Tokyo-To, Japan

The Specialty Hospital Advanced Clinical Center

Amman, Jordan

Jordan University Hospital

Amman, Jordan

Abdali Hospital

Amman, Jordan

Istiklal Hospital

Amman, Jordan

Pharmaceutical research center at Jordan University of Science and Technology

Irbid, Jordan

Irbid Specialty Hospital

Irbid, Jordan

Saint George Hospital University Medical Center

Beirut, Lebanon

American University of Beirut

Beirut, Lebanon

Hotel Dieu de France Hospital

Beirut, Lebanon

Ain Wazein Medical Village

El Shouf, Lebanon

Siauliai Republican Hospital

Šiauliai, Lithuania

Inlita, JSC, Center of Santaros Clinical Trials

Vilnius, Lithuania

Vilnius University Hospital

Vilnius, Lithuania

CIMAB SA de CV

Torreón, Coahuila, Mexico

CIMOVA (Consultorio anexo)

León, Guanajuato, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, Mexico

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

Guadalajara, Jalisco, Mexico

Centro de Estudios de Investigacion Basica y Clinica SC

Guadalajara, Jalisco, Mexico

Centro de investigacion medica y reumatologia

Guadalajara, Jalisco, Mexico

Consultorio Privado Dr. Miguel Cortes Hernandez

Cuernavaca, Morelos, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Centro de Investigacion de Tratamientos Innovadores de Sinaloa SC

Culiacán, Sinaloa, Mexico

Unidad de Atencion Medica e Investigacion en Salud

Mérida, Yucatán, Mexico

Centro de Investigacion en Reumatologia

Mérida, Yucatán, Mexico

Medical Care & Research SA de CV

Mérida, Yucatán, Mexico

Investigacion y Biomedicina de Chihuahua, Sociedad Civil

Chihuahua City, Mexico

Centro de Investigacion y Atencion Integral Durango S.C.

Durango, Mexico

Clinstile, S.A. de C.V.

Mexico City, Mexico

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

San Luis Potosí City, Mexico

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

San Luis Potosí City, Mexico

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Clinica El Golf

Lima, Peru

Clinica Internacional Sede San Borja

Lima, Peru

Hospital Nacional Cayetano Heredia

Lima, Peru

Ospital Ng Makati

City of Taguig, Philippines

Manila Doctors Hospital

Manila, Philippines

The Medical City

Ortigas, Philippines

St. Luke's Medical Center

Quezon City, Philippines

Nova Reuma

Bialystok, Poland

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, Poland

Centrum Medyczne Intercor Sp. z o.o

Bydgoszcz, Poland

Centrum Medyczne K2J2

Częstochowa, Poland

Centrum Medyczne Pratia Czestochowa

Częstochowa, Poland

Ambulatorium Sp z o o

Elblag, Poland

FutureMeds Gdynia

Gdynia, Poland

MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.

Grodzisk Mazowiecki, Poland

Centrum Medyczne Pratia Katowice

Katowice, Poland

Malopolskie Badania Kliniczne

Krakow, Poland

FutureMeds Krakow

Krakow, Poland

SOMED CR

Lodz, Poland

FutureMeds

Lodz, Poland

Clinical Trials Umed Sp.z o.o

Lodz, Poland

ETG Lublin

Lublin, Poland

Reumed Spolka z o.o.

Lublin, Poland

Provita Profamilia

Piotrkow Trybunalski, Poland

Pratia Poznan

Poznan, Poland

NSZOZ Termedica - Centrum Badan Klinicznych

Poznan, Poland

Clinical Research Center Spółka z

Poznan, Poland

ETG Siedlce

Siedlce, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Poland

ETG JustMed

Warsaw, Poland

PRATIA S.A. MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Izabela Inglot Szczebiot

Warsaw, Poland

Centrum Medyczne Reuma Park

Warsaw, Poland

FutureMeds

Warsaw, Poland

REUMA CENTRUM Specjalistyczna Praktyka Lekarska

Warsaw, Poland

Centrum Medyczne K2J2

Wołomin, Poland

FutureMeds

Wroclaw, Poland

ETG Zamosc

Zamość, Poland

Unidade Local de Saude de Coimbra

Coimbra, Portugal

Hospital CUF Descobertas

Lisbon, Portugal

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

Ponte de Lima, Portugal

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

Vila Nova de Gaia, Portugal

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

Brasov, Romania

S.C Delta Health Care S.R.L

Bucharest, Romania

SC Aqua Med Consulting SRL

Constanța, Romania

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

King Saud University Medical City

Riyadh, Saudi Arabia

Institute of Rheumatology

Belgrade, Serbia

Special Hospital for Rheumatic Diseases

Novi Sad, Serbia

Artromac

Košice, Slovakia

MEDMAN s.r.o.

Martin, Slovakia

MEDMAN

Martin, Slovakia

Narodny ustav reumatickych chorob

Piešťany, Slovakia

ALBAMED

Zvolen, Slovakia

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

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

Suwon, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Soonchunhyang University Seoul Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

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

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain

Hospital Universitario de Badajoz

Badajoz, Badajoz, Spain

Sanitas ES Sanitas Hospital CIMA

Barcelona, Barcelona, Spain

Hospital Universitari Vall d'Hebron - VHIR

Barcelona, Barcelona, Spain

Clinica GAIAS Santiago

Santiago de Compostela, La Coruña, Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Quironsalud Infanta Luisa

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Studieenheten

Stockholm, Sweden

Hopital Habib Thameur

Montfleury, Tunisia

EPS Hopital Mohamed Taher Maamouri

Nabeul, Tunisia

Hedi Chaker Hospital

Sfax, Tunisia

Hedi Chaker Hospital

Sfax, Tunisia

Hospital Farhat Hached

Sousse, Tunisia

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Karadeniz Technical University Faculty of Medicine

Trabzon, Turkey (Türkiye)

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Royal Hallamshire Hospital

Sheffield, West Midlands, United Kingdom

Cannock Chase Hospital

Cannock, United Kingdom

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NCT06684847