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

Recruiting now · Phase 1

Conditions studied: Systemic Lupus Erthematosus

In brief

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).

Key facts

Study ID

NCT07136389

Run by

Biocad

People needed

135

Starts

2025-03-27

Expected to finish

2026-11-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent to participate in the study and the subject's ability to comply with the requirements of the clinical study protocol.
• Age from 18 to 70 years at the time of signing the informed consent form.
• Body weight from 45 kg, BMI of 18 to 30 kg/m2.
• Diagnosed with SLE in accordance with at least 4 classification criteria of SLICC (2012), including 1 clinical sign or 1 immunological manifestation.
• Disease activity according to the SLEDAI score of 6-12.
• CLASI-A ≥ 9 at screening, at least one skin lesion with R-CLASI ≥ 6 at screening.
• Positive test for antinuclear antibodies at screening (titer ≥ 1:160) and/or increased level of double-stranded DNA antibody (≥ 2 ULN).
• History of the disease ≥24 weeks at the time of signing the informed consent form.
• Active skin disease according to the CLASI scale, despite the use of topical and systemic glucocorticoids and/or antimalarial drugs for at least 3 months at the time of signing the informed consent form.
• Women of childbearing potential have a negative pregnancy test at screening.
• Willingness of men and women of childbearing potential to use two highly effective contraception methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose. In this study, a woman is considered to be of childbearing potential if she is postmenarcheal, did not reach menopause (amenorrhea for ≥12 months, which cannot be explained by any other cause than menopause), and did not undergo surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus).

You may not qualify if…

• Presence of active lupus nephritis or chronic kidney disease (urine protein to creatinine ratio >2.0 or estimated glomerular filtration rate < 30 mL/min/1.73m2).
• A history of CNS associated with SLE, involvement including, but not limited to, the following symptoms: seizures, impaired consciousness, psychosis, delirium or confusion, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, multiple mononeuritis, or demyelinating syndromes.
• The presence of uncontrolled neuropsychiatric disorders, severe depression and/or suicide attempts at the time of signing the ICF or within 1 year prior to signing the informed consent form, as well as the risk of suicide and/or any mental illness as assessed by the investigator.
• A history of antiphospholipid syndrome.
• Use of the following groups of drugs before signing ICF:
• abatacept, belimumab, tocilizumab or tumor necrosis factor (TNF) inhibitors within 3 months or 5 half-lives prior to screening (whichever is longer);
• rituximab, atacicept, ocrelizumab or other biological agents targeting B cells within 9 months prior to screening;
• cyclosporine, tacrolimus, pimecrolimus, sirolimus, imiquimod, intravenous immunoglobulin, intravenous and oral cyclophosphamide, and plasmapheresis within 3 months prior to screening;
• thalidomide or lenalidomide within 2 months prior to screening;
• receiving oral glucocorticoids at a dose of > 20 mg /day in terms of prednisone or dose changes for at least 4 weeks prior to screening;
• other immunosuppressive or disease modifying treatments for SLE under at least one of the following conditions:
• the drugs were started less than 3 months before screening,
• the dose was changed within 1 month prior to screening,
• the medications were taken in doses exceeding the specified amounts: antimalarial drugs (hydroxychloroquine up to 6.5 mg/kg/day, quinacrine up to 5 mg/kg/day, chloroquine 3 mg/kg/day), dapsone 150 mg/day, methotrexate 20 mg/week, azathioprine 200 mg/day, 6-mercaptopurine 1.5 mg/kg/day, and mycophenolate mofetil 2 g/day or mycophenolate sodium 1440 mg/day.
• Laboratory test values:
• absolute neutrophil count <1,500/µL (1.5×109/L);
• lymphocyte count <800/µL cells×109/L (0.8×109/L);
• platelets <75,000/µL (75×109/L);
• hemoglobin ≤ 9 g/dL (≤ 90 g/L);
• serum creatinine >1.5×ULN, OR for subjects with a creatinine level >1.5×ULN, creatinine clearance/glomerular filtration rate <30 mL/min ;
• total bilirubin > 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin levels should not exceed 50 µmol/L);
• AST or ALT >2×ULN;
• alkaline phosphatase >2×ULN.
• Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:
• uncontrolled hypertension (subjects with arterial hypertension not controlled by 3 antihypertensive drugs (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg));

Where it is running

• "Multidisciplinary medical center for adults and children №157" — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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