Study of Safety and Effects of BCD-256 Alone and With Divozilimab in Adults With Systemic Lupus Erythematosus

What this Trial Is About

Researchers are studying the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and early effects of BCD-256 alone and combined with divozilimab, an anti-CD20 therapy, in people with mild to moderate systemic lupus erythematosus SLE who have skin lesions. The study focuses on participants receiving second- or later-line therapy and is conducted in two stages, with an initial dose escalation followed by combination therapy assessment. Stage 1 uses a modified 33 design where BCD-256 doses are gradually increased across cohorts 1 to 3, with parallel administration of divozilimab in cohorts 4 and 5. Safety is closely monitored, and progression to Stage 2 depends on approval from a safety committee after 12 weeks of therapy. Stage 2 involves four cohorts receiving BCD-256 combined with divozilimab at doses determined from Stage 1 results, also over 12 weeks. Participants will receive intravenous infusions of BCD-256 and divozilimab according to their assigned cohort. Researchers will monitor adverse events during 85 days, including serious and treatment-related ones, and measure pharmacokinetic parameters like peak drug concentration and half-life in the first treatment cycle. The total study participation is planned to last through these treatment and observation periods to assess safety and treatment effects.

Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus