A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Phase 3 – large-scale trial before approval
Conditions:
Primary Sjogrens Disease
Sponsor: argenx
trial.available_in:
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Overview
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.
Who can participate
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
Locations
36
Argentina (1)
Centro Medico Arsema
CABA , Buenos Aires
Australia (1)
Westmead Hospital
Sydney , New South Wales
Belgium (1)
Erasme Hospital
Brussels
Bulgaria (1)
MC Artmed OOD
Plovdiv
Canada (1)
Applied Medical Informatics Research Inc.
Montreal , Quebec
Chile (1)
CTR Estudios
Santiago
China (1)
The First Affiliated Hospital of Bengbu Medical College
Bengbu , Anhui
Colombia (1)
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla
Estonia (1)
OÜ Innomedica
Tallinn
France (1)
Hôpital Saint Joseph
Marseille , Bouches-du-Rhône
Georgia (1)
The First University Clinic of Tbilisi State Medical University
Tbilisi
Germany (1)
Universitaetsklinikum
Tübingen , Baden-Wurttemberg
Greece (1)
Euroclinic of Athens
Athens
Hungary (1)
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest
Ireland (1)
Clinical Research Ctr
Dublin
Israel (1)
Barzilai Medical Center
Ashkelon
Italy (1)
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia
Japan (1)
JCHO Chukyo Hospital
Nagoya , Aichi-ken
Jordan (1)
The Specialty Hospital Advanced Clinical Center
Amman
Lebanon (1)
Saint George Hospital University Medical Center
Beirut
Lithuania (1)
Siauliai Republican Hospital
Šiauliai
Mexico (1)
CIMAB SA de CV
Torreón , Coahuila
Netherlands (1)
Universitair Medisch Centrum Groningen
Groningen
Peru (1)
Clinica El Golf
Lima
Philippines (1)
Ospital Ng Makati
City of Taguig
Poland (1)
Nova Reuma
Bialystok
Romania (1)
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
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