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

NCT07136389 | Recruiting Phase 1 DMC

• 1 other identifier: BCD-256-1
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Systemic Lupus Erthematosus

Keywords

divozilimab; anti-BDCA2; anti-CD20

Outcome Measures

Primary Outcomes (6)

• Proportion of subjects with adverse events

  85 days

• Proportion of subjects with serious adverse events

  85 days

• Proportion of subjects with treatment-related adverse events

  85 days

• Proportion of subjects with CTCAE 5.0 grade ≥ 3 adverse events

  85 days

• Proportion of cases of early discontinuation of study therapy due to adverse events

  85 days

• Proportion of subjects with adverse events of special interest

  85 days

Secondary Outcomes (2)

• Time to Reach Maximum Observed Concentration (Tmax) in the first cycle of therapy

  0-15 days

• Terminal Elimination Half-Life (t1/2) in the first cycle of therapy

  0-15 days

Other Outcomes (5)

• Area Under the Concentration-Time Curve from Time 0 to ending at the last measured concentration at time t (AUC0-t) in the first cycle of therapy

  0 -15 days

• Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) in the first cycle of therapy

  0 - 15 days

• Area Under the plasma-concentration versus time curve (AUC) over one dosing interval (τ) when steady-state (ss) conditions have been reached, representing the average drug exposure during that interval n the third cycle of therapy

  57 - 85 days

Study Arms (9)

BCD-256 Cohort 1

EXPERIMENTAL

Drug: BCD-256

BCD-256 Cohort 2

EXPERIMENTAL

Given satisfactory tolerability (no DLT events in all cohort 1 subjects for 14 days from the start of BCD-256 therapy), the subjects are included at the second dose level.

Drug: BCD-256

BCD-256 Cohort 3

EXPERIMENTAL

Given satisfactory tolerability (no DLT events in all cohort 2 subjects for 14 days from the start of therapy), the subjects are included at the third dose level.

Drug: BCD-256

Divozilimab Cohort 4

EXPERIMENTAL

The inclusion of subjects in Cohort 4 occurs in parallel with the enrollment of subjects in cohorts 1-3.

Drug: Divozilimab

Divozilimab Cohort 5

EXPERIMENTAL

The inclusion of subjects in Cohort 5 occurs in parallel with the enrollment of subjects in cohorts 1-3.

Drug: Divozilimab; Drug: BCD-256

Cohort A

EXPERIMENTAL

Subjects will receive BCD-256 plus divozilimab

Drug: Divozilimab; Drug: BCD-256

Cohort B

EXPERIMENTAL

Subjects will receive BCD-256 plus divozilimab

Drug: Divozilimab; Drug: BCD-256

Cohort C

EXPERIMENTAL

Subjects will receive BCD-256 plus divozilimab

Drug: Divozilimab; Drug: BCD-256

Cohort D

EXPERIMENTAL

Subjects will receive BCD-256 plus divozilimab

Drug: Divozilimab; Drug: BCD-256

Interventions

BCD-256 DRUG

Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously

Also known as: Anti-BDCA2

BCD-256 Cohort 1

Divozilimab DRUG

Ant-CD0 human monoclonal antibody, Concentrate for solution for infusion intravenously

Also known as: Anti-CD20

Cohort A; Cohort B; Cohort C; Cohort D; Divozilimab Cohort 4; Divozilimab Cohort 5

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

"Multidisciplinary medical center for adults and children №157"

Saint Petersburg, 196128, Russia

RECRUITING

Related Links

• Clinical Trials \| BIOCAD

Study Officials

• Arina V Zinkina-Orikhan, PhD

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Central Study Contacts

Anastasiia S Admakina, MD

CONTACT

+ 7 (931) 311 90 49; admakina@biocad.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 22, 2025
• Study Start: March 27, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)