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

Name: Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus — clinical trial record (NCT07136389)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 1

SponsorBiocad

Started2025-03-27

View on ClinicalTrials.gov ↗

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.

Biocad

26 trials monitored

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Lupus (SLE)

648 trials monitored

See 25 trials at risk

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