Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus
Trial Parameters
Brief Summary
The goal of this clinical trial to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of BCD-256 alone and in combination with anti-CD20 therapy (divozilimab) as second- or later-line therapy in subjects with skin lesions due to mild to moderate systemic lupus erythematosus. The study consists of the first stage (cohorts 1-5) and the second stage (cohorts A - D).
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent to participate in the study and the subject's ability to comply with the requirements of the clinical study protocol. 2. Age from 18 to 70 years at the time of signing the informed consent form. 3. Body weight from 45 kg, BMI of 18 to 30 kg/m2. 4. Diagnosed with SLE in accordance with at least 4 classification criteria of SLICC (2012), including 1 clinical sign or 1 immunological manifestation. 5. Disease activity according to the SLEDAI score of 6-12. 6. CLASI-A ≥ 9 at screening, at least one skin lesion with R-CLASI ≥ 6 at screening. 7. Positive test for antinuclear antibodies at screening (titer ≥ 1:160) and/or increased level of double-stranded DNA antibody (≥ 2 ULN). 8. History of the disease ≥24 weeks at the time of signing the informed consent form. 9. Active skin disease according to the CLASI scale, despite the use of topical and systemic glucocorticoids and/or antimalarial drugs for at least 3 months at the time of signing the in