Overview
The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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