Actively Recruiting
An Open-label, Non-comparative Study of Safety and Immune Response to BCD-256 and Divozilimab Given by Intravenous Infusion in People With Systemic Lupus Erythematosus
Led by Biocad · Updated on 2025-08-22
135
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
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 "3+3" 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.
CONDITIONS
Brief Title
Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to follow study requirements
- Age between 18 and 70 years at consent
- Body weight at least 45 kg and BMI between 18 and 30 kg/m2
- Diagnosed with systemic lupus erythematosus meeting at least 4 SLICC classification criteria
- Disease activity score (SLEDAI) between 6 and 12
- CLASI-A score 9 or higher and at least one skin lesion with R-CLASI 6 or higher at screening
- Positive antinuclear antibody test or elevated double-stranded DNA antibody level
- Disease history of at least 24 weeks
- Active skin disease despite topical or systemic glucocorticoids and/or antimalarial drugs for at least 3 months
- Negative pregnancy test for women of childbearing potential
- Willingness to use two effective contraception methods during and for 6 months after treatment
You will not qualify if you...
- Active lupus nephritis or severe kidney disease
- History of central nervous system involvement related to SLE
- Uncontrolled neuropsychiatric disorders or severe depression within the past year
- History of antiphospholipid syndrome
- Recent use of certain biologic or immunosuppressive drugs within specified timeframes
- Laboratory abnormalities including low blood cell counts or elevated liver enzymes
- Uncontrolled hypertension or significant heart, lung, or respiratory diseases
- Other active skin diseases that could interfere with study assessment
- Systemic glucocorticoid therapy for other diseases
- Recent or active serious infections including herpes, tuberculosis, HIV, hepatitis
- Recent major surgery or COVID-19 infection
- Participation in other clinical trials within 3 months prior to consent
- Comorbid conditions increasing risk or affecting lupus assessment
- History of certain cancers with remission less than 5 years
- Inability to receive intravenous drugs
- Allergies to study drug components or humanized antibodies
- Pregnancy, breastfeeding, or plans for pregnancy or fatherhood during and 6 months after study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 12 weeks of therapy per stage
Participants receive intravenous infusions of BCD-256 and/or divozilimab in different cohorts, including dose escalation and combination therapy over multiple cycles.
Multiple infusion visits over 12 weeks depending on cohort assignment
Duration - Up to 85 days after treatment
Participants are monitored for safety, adverse events, and pharmacokinetics after completing treatment.
Approximately 3 to 4 follow-up visits
Trial Site Locations
Total: 1 location
1
"Multidisciplinary medical center for adults and children №157"
Saint Petersburg, Russia, 196128
Actively Recruiting
Research Team
A
Anastasiia S Admakina, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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