BCD-256-1, An Open-Label Non-Comparative Clinical Study of the Safety, Pharmacokinetics, and Immunogenicity of BCD-256 and Divosilimumab in Monotherapy and Combination Therapy Regimens for Single and Multiple Intravenous Dosing to Subjects With Systemic Lupus Erythematosus.
The safety, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of the investigational drug product BCD-256 and divosilimumab in monotherapy and combination therapy regimens will be studied in the clinical trial in participants with mild to moderate systemic lupus erythematosus who:
Are from 18 to 70 years.
Have a documented diagnosis of systemic lupus erythematosus established according to at least four SLICC classification criteria1(2012 [s2]), including one clinical sign or one immunologic manifestation.
Have a disease activity of 6–12 according to the SLEDAI2.
Have a CLASI-A index score3 ≥ 9 at the time of screening and at least one skin focus with an R-CLASI4 score ≥ 6 at the time of screening.
Have a positive antinuclear antibody test at the time of screening (titer ≥ 1:160) and/or elevated anti-double-stranded DNA (≥ 2 above the normal limit).
Have documentated disease duration ≥ 24 weeks at the time of signing the informed consent form.
Have active CLASI skin lesions5 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.
Agree to use reliable contraception methods during participation in the clinical study and for 6 months after it.
This clinical study has non-inclusion criteria (criteria for non-eligibility to participate in a particular clinical study); the full list will be provided to a potential participant by the Investigator. In particular, the non-inclusion criteria are:
Presence of active lupus nephritis or CKD (protein/creatinine ratio> 2.0 or estimated glomerular filtration rate <30 ml/min/1.73 m2).
A history of CNS involvement7 associated with systemic lupus erythematosus including, but not limited to, the following symptoms: seizures, impaired consciousness, psychosis, delirium or state of confusion, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, multiple mononeuritis, or demyelinating syndromes.
Uncontrolled neuropsychiatric disorders, severe depression and/or suicide attempts at the time of signing the informed consent form or within 1 year prior to signing the informed consent form, and suicide risk and/or any psychiatric diseases as assessed by the Investigator.
A history of antiphospholipid syndrome.
Use of the following groups of drugs prior to signing the informed consent form:
abatacept, belimumab, tocilizumab, or tumor necrosis factor inhibitors for 3 months or 5 half-life periods prior to screening (whichever is longer)
rituximab, atacicept, ocrelizumab, or other B-cell-targeting biological medicinal products within 9 months prior to screening
cyclosporine, tacrolimus, pimecrolimus, sirolimus, imiquimod, intravenous immunoglobulin, intravenous or oral cyclophosphamide, and plasmapheresis within 3 months prior to screening
thalidomide or lenalidomide within 2 months prior to screening
current oral glucocorticoid use at a dose > 20 mg/day in prednisolone equivalent or a change in dose for at least 4 weeks prior to screening
other immunosuppressive or disease-modifying treatments for systemic lupus erythematosus.
Laboratory test values not consistent with adequate functions of organs and systems.
Any other comorbidity or concomitant condition that, according to the Investigator, significantly increases the risk of adverse events during the clinical study.
Any active skin disease, other than systemic lupus erythematosus, that may preclude participation in a clinical study and evaluation of effect.
Documented presence of one or more systemic comorbidities requiring systemic glucocorticoid therapy.
History of herpetic infection: herpetic encephalitis, ophthalmic herpes, or disseminated herpetic infection.
HIV infection, hepatitis B, active hepatitis C.
Lymphoproliferative diseases or solid tumors with a remission of less than 5 years, except cured cervical cancer in situ. .
Clinical study BCD-256-1 is conducted in study centers in different cities of the Russian Federation, such as Moscow, St. Petersburg, Ufa, Yaroslavl, Izhevsk, Chelyabinsk, Ekaterinburg , and Ulyanovsk.
To query about participating in a clinical study, including contact details of study centers, please use a special form at ct.biocad.ru.
The Investigator will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study, as well as about other drug products used in the study. The potential participant should read the complete study information and consult with the Investigator and/or Treating Physician.
Clinical Study Authorization No. 85 dated February 19, 2025 of the Ministry of Health of the Russian Federation and the list of approved study centers in the territory of the Russian Federation have been published in the State Register of Medicines.
SLICC is the Systemic Lupus International Collaborating Clinics.
SLEDAI is the Systemic Lupus Erythematosus Disease Activity Index.
CLASI-A is the Cutaneous Lupus Disease Area and Severity Index—Disease Activity.
R-CLASI is the Revised Cutaneous Lupus Erythematosus Disease Areas and Severity Index.
CLASI is the Cutaneous Lupus Disease Area and Severity Index.