Last updated 24 days ago
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
81 patients around the world
Available in Puerto Rico, Chile, United States
argenx
3Research sites
81Patients around the world
This study is for people with
Rare diseases
Systemic sclerosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Is aged ≥18 years and the local legal age of consent for clinical studies.Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria.Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160.Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3.Has a modified Rodnan Skin Score (mRSS) score between 15 and 35.The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening.Has uninvolved or mildly thickened skin area in at least 1 injection site.
- Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory.Significant Pulmonary Arterial Hypertension.Severe digital vasculopathy within the past 3 months.Skin thickening due to scleroderma mimics or localized scleroderma.Scleroderma renal crisis within the past 6 months of participating to the study.Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia.
Sites
BIOCINETIC SpA
Recruiting
Centro de Investigaciones Clínicas UC - CICUC
Recruiting
Centro Médico Vanguardia
Recruiting
StudyeSScape
Sponsorargenx
Study typeInterventional
Conditions
Systemic sclerosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06655155
