Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus
An Open-label, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Immunogenicity BCD-256 and Divozilimab in Monotherapy and Combination Therapy With Single and Multiple Intravenous Administration to Subjects With Systemic Lupus Erythematosus
Biocad
135 participants
Mar 27, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
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Interventions
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
Ant-CD0 human monoclonal antibody, Concentrate for solution for infusion intravenously
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
Locations(1)
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NCT07136389