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ACTIVE NOT RECRUITING
NCT06684847
PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

631

Start Date

2025-01-15

Completion Date

2028-07

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

Efgartigimod PH20 SC

subcutaneous efgartigimod PH20 SC given by prefilled syringe

OTHER

Placebo PH20 SC

subcutaneous placebo PH20 SC given by prefilled syringe

Locations (303)

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

And 203 more locations on ClinicalTrials.gov