NCT07136389

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study is conducted in 2 stages which involve different subjects. Stage 1 of the study have a modified "3+3" design and involves dose escalation of BCD-256 in 1-3 cohorts with an interval of at least 14 days dose - limiting toxicicity (DLT) (DLT assessment period) between cohorts 1-3. In cohorts 4 and 5, the administration of divozilimab is carried out in parallel with cohorts 1-3. A decision on the possibility of starting Stage 2 and including new subjects in it will be made after approval by thethe Cohort Dosing Safety Committee (CDSC) of an interim report (for 12 weeks of therapy). Stage 2 of the study will involve the use of BCD-256 in combination with divozilimab in 4 cohorts, BCD-256 dose levels in cohorts will be determined based on the results of the main period of Stage 1 (for 12 weeks of therapy).

Conditions

• Systemic Lupus Erthematosus

Interventions

Type	Name	Description
DRUG	BCD-256	Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
DRUG	BCD-256	Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
DRUG	BCD-256	Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
DRUG	Divozilimab	Ant-CD0 human monoclonal antibody, Concentrate for solution for infusion intravenously
DRUG	BCD-256	Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously

Timeline

• Start date: 2025-03-27
• Primary completion: 2026-01-01
• Completion: 2026-11-01
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: Russia