Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated August 22, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
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).
Trial Details
NCT Number NCT07136389
Lead Sponsor Biocad
Conditions Systemic Lupus Erthematosus
Enrollment 135 participants
Start Date 2025-03-27
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-22