Overview
The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects will be randomized to divozilimab or placebo group.
Eligibility
Inclusion Criteria:
- Diagnosis of "systemic scleroderma" in accordance with the ACR/EULAR 2013 classification.
- Modified Rodnan skin score (mRSS) from 10 to 20.
- FVC ≥ 40 % of the due value.
Exclusion Criteria:
- Induced scleroderma.
- Silicone implants/protheses.
- Digital ulcers with signs of infection or indications for any amputation.
- Blood biochemistry or hematological abnormalities at screening.
- FEV1/FVC < 0.7 and FEV1< 50 % at screening.
- History of threatment with anti-CD20 monoclonal antibodies.