Sabine Coppieters, MD

CONTACT

Lead Sponsor

argenx

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

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