Systemic Lupus ErthematosusPhase 1NCT07136389
Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus
A Phase 1 study testing BCD-256 and Divozilimab in people with Systemic Lupus Erthematosus, run by Biocad at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erthematosus
- What is being tested?
- BCD-256 and Divozilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteRussia
- Study dates
- 27 Mar 2025to 1 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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);
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- 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));
- stable angina pectoris, functional class III-IV according to the Canadian Cardiovascular Society, CCS;
- acute coronary syndrome less than 6 months before the start of therapy in the study;
- congestive heart failure (NYHA III-IV);
- clinically significant arrhythmia at the opinion of the investigator that are not amenable to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the first dose of BCD 256/divozilimab);
- moderate or severe asthma, stage III-IV chronic obstructive pulmonary disease, history of angioneurotic edema, severe respiratory failure;
- any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.
- Any active skin diseases other than SLE that may interfere with the study and effect assessment (e.g., psoriasis, drug-induced lupus, vitiligo, rosacea, local skin infections).
- Documented presence of one or more systemic concomitant diseases requiring systemic glucocorticoid therapy (e.g., asthma, IBD, psoriasis, acute uveitis). Oral, rectal or any injectable route of administration will be considered systemic.
- Exception: concomitant diseases requiring the use of glucocorticoids by other methods of administration (for example, topical, inhalation, intranasal, into the conjunctival sac, etc.) are allowed. Subjects with endocrinopathy requiring only hormone replacement therapy are also eligible.
- A history of herpes infection: herpes encephalitis, ocular herpes, and disseminated herpes infection.
- Documented diagnosis of chickenpox, cytomegalovirus infection, infectious mononucleosis, herpes zoster, genital herpes, herpetic gingivostomatitis within 3 months before signing the ICF and during the screening period.
- A current diagnosis or a history of a severe immunodeficiency of any origin.
- A history of or active or latent tuberculosis (positive Diaskintest®, QuantiFERON or T-SPOT.TB test, in the absence of signs of pulmonary tuberculosis on chest X-ray or CT). Subjects who have ongoing social contacts with active tuberculosis should also not be included in the clinical study.
- A documented diagnosis of any other chronic infection that, in the opinion of the investigator, can increase the risk of infectious complications .
- Active infectious diseases (requiring hospitalization, parenteral use of antibacterial, antimycotic or antiprotozoal drugs) within 8 weeks prior to signing the ICF and during the screening period.
- Systemic antibacterial, antimycotic or antiprotozoal therapy within 8 weeks prior to signing the ICF and during the screening period.
- Scheduled vaccination with live, live attenuated vaccines or non-live vaccines within 1 month prior to screening and throughout the study, and within 4 months after the last dose of the study drug or divozilimab.
- Established HIV infection, hepatitis B, active hepatitis C .
- COVID-19, major surgery within 4 weeks prior to signing the ICF or major surgery planned for the period of participation in the study.
- Simultaneous participation in other clinical studies, as well as previous participation in other clinical studies less than 3 months before signing the ICF, prior participation in the main period of this study.
- Exception: subjects who dropped out of this study at screening.
- Comorbidities (including, but not limited to, metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, gastrointestinal disorders), including disorders ongoing at the time of screening, which, in the opinion of the investigator, may affect the course of SLE, the results of assessment of its symptoms, or create an unacceptable risk to the subject from study therapy.
- Lymphoproliferative diseases or solid tumors (including basal cell carcinoma in situ) with a remission duration of less than 5 years, except for cured cervical cancer in situ.
- Impossibility of intravenous administration of drugs.
- Hypersensitivity or allergy to any of the components of BCD-256 and divozilimab. A history of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or hybrid proteins.
- Pregnancy or breastfeeding, or planning pregnancy or fatherhood throughout the study and for 6 months after the last dose of the drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
"Multidisciplinary medical center for adults and children №157"
Saint Petersburg, 196128
Elena S Zhugrova, MD, PhD
About this study
Official title: An Open-label, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Immunogenicity BCD-256 and Divozilimab in Monotherapy and Combination Therapy With Single and Multiple Intravenous Administration to Subjects With Systemic Lupus Erythematosus
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).
Read the detailed description
The study is conducted in 2 stages which involve different subjects. Stage 1 of the study have a modified "3+3" design and involves dose escalation of BCD-256 in 1-3 cohorts with an interval of at least 14 days dose - limiting toxicicity (DLT) (DLT assessment period) between cohorts 1-3. In cohorts 4 and 5, the administration of divozilimab is carried out in parallel with cohorts 1-3. A decision on the possibility of starting Stage 2 and including new subjects in it will be made after approval by thethe Cohort Dosing Safety Committee (CDSC) of an interim report (for 12 weeks of therapy). Stage 2 of the study will involve the use of BCD-256 in combination with divozilimab in 4 cohorts, BCD-256 dose levels in cohorts will be determined based on the results of the main period of Stage 1 (for 12 weeks of therapy).
- Conditions
- Systemic Lupus Erthematosus
- Being tested
- BCD-256, Divozilimab
- Keywords
- divozilimab, anti-BDCA2, anti-CD20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-256Drug
Also called Anti-BDCA2
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
BCD-256Drug
Also called Anti-BDCA2
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
BCD-256Drug
Also called Anti-BDCA2
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
DivozilimabDrug
Also called Anti-CD20
Ant-CD0 human monoclonal antibody, Concentrate for solution for infusion intravenously
BCD-256Drug
Also called Anti-BDCA2
Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously
| Study group | Role | What they receive |
|---|---|---|
| BCD-256 Cohort 1 | Experimental | Not described Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Divozilimab; Drug: BCD-256 |
| Cohort A | Experimental | Subjects will receive BCD-256 plus divozilimab Receives: Drug: Divozilimab; Drug: BCD-256 |
| Cohort B | Experimental | Subjects will receive BCD-256 plus divozilimab Receives: Drug: Divozilimab; Drug: BCD-256 |
| Cohort C | Experimental | Subjects will receive BCD-256 plus divozilimab Receives: Drug: Divozilimab; Drug: BCD-256 |
| Cohort D | Experimental | Subjects will receive BCD-256 plus divozilimab Receives: Drug: Divozilimab; Drug: BCD-256 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with adverse events
Measured: 85 days
Proportion of subjects with serious adverse events
Measured: 85 days
Proportion of subjects with treatment-related adverse events
Measured: 85 days
Proportion of subjects with CTCAE 5.0 grade ≥ 3 adverse events
Measured: 85 days
Proportion of cases of early discontinuation of study therapy due to adverse events
Measured: 85 days
Proportion of subjects with adverse events of special interest
Measured: 85 days
Secondary outcomes (2)
Time to Reach Maximum Observed Concentration (Tmax) in the first cycle of therapy
Measured: 0-15 days
Terminal Elimination Half-Life (t1/2) in the first cycle of therapy
Measured: 0-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start27 Mar 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arina V Zinkina-Orikhan, PhD, Study director, Director of Clinical Development Department, BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136389
- Sponsor's protocol ID
- BCD-256-1
- Status last verified
- Jun 2025
- First submitted
- 8 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Immunogenicity BCD-256 and Divozilimab in Monotherapy and Combination Therapy With Single and Multiple Intravenous Administration to Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07136389
- Acronym / sponsor ID
- BCD-256-1
- Conditions
- Systemic Lupus Erthematosus
- Keywords
- divozilimab, anti-BDCA2, anti-CD20
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study is conducted in 2 stages which involve different subjects. Stage 1 of the study have a modified "3+3" design and involves dose escalation of BCD-256 in 1-3 cohorts with an interval of at least 14 days dose - limiting toxicicity (DLT) (DLT assessment period) between cohorts 1-3. In cohorts 4 and 5, the administration of divozilimab is carried out in parallel with cohorts 1-3. A decision on the possibility of starting Stage 2 and including new subjects in it will be made after approval by thethe Cohort Dosing Safety Committee (CDSC) of an interim report (for 12 weeks of therapy). Stage 2 of the study will involve the use of BCD-256 in combination with divozilimab in 4 cohorts, BCD-256 dose levels in cohorts will be determined based on the results of the main period of Stage 1 (for 12 weeks of therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| BCD-256 Cohort 1 | Experimental | Drug: BCD-256 |
| BCD-256 Cohort 2 | Experimental | Drug: BCD-256Given 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. |
| BCD-256 Cohort 3 | Experimental | Drug: BCD-256Given 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. |
| Divozilimab Cohort 4 | Experimental | Drug: DivozilimabThe inclusion of subjects in Cohort 4 occurs in parallel with the enrollment of subjects in cohorts 1-3. |
| Divozilimab Cohort 5 | Experimental | Drug: Divozilimab, Drug: BCD-256The inclusion of subjects in Cohort 5 occurs in parallel with the enrollment of subjects in cohorts 1-3. |
| Cohort A | Experimental | Drug: Divozilimab, Drug: BCD-256Subjects will receive BCD-256 plus divozilimab |
| Cohort B | Experimental | Drug: Divozilimab, Drug: BCD-256Subjects will receive BCD-256 plus divozilimab |
| Cohort C | Experimental | Drug: Divozilimab, Drug: BCD-256Subjects will receive BCD-256 plus divozilimab |
| Cohort D | Experimental | Drug: Divozilimab, Drug: BCD-256Subjects will receive BCD-256 plus divozilimab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (51 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-256Also: Anti-BDCA2Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously | Drug | BCD-256 Cohort 1 |
| BCD-256Also: Anti-BDCA2Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously | Drug | BCD-256 Cohort 2 |
| BCD-256Also: Anti-BDCA2Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously | Drug | BCD-256 Cohort 3 |
| DivozilimabAlso: Anti-CD20Ant-CD0 human monoclonal antibody, Concentrate for solution for infusion intravenously | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Divozilimab Cohort 4, Divozilimab Cohort 5 |
| BCD-256Also: Anti-BDCA2Anti-BDCA2 human monoclonal antibody, concentrate for solution for infusion intravenously | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Divozilimab Cohort 5 |
Primary outcome
Proportion of subjects with adverse events
Time frame: 85 days
Proportion of subjects with serious adverse events
Time frame: 85 days
Proportion of subjects with treatment-related adverse events
Time frame: 85 days
Proportion of subjects with CTCAE 5.0 grade ≥ 3 adverse events
Time frame: 85 days
Proportion of cases of early discontinuation of study therapy due to adverse events
Time frame: 85 days
Proportion of subjects with adverse events of special interest
Time frame: 85 days
2 secondary outcomes
Time to Reach Maximum Observed Concentration (Tmax) in the first cycle of therapy
Time frame: 0-15 days
Terminal Elimination Half-Life (t1/2) in the first cycle of therapy
Time frame: 0-15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Clinical Trials \| BIOCADLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arina V Zinkina-Orikhan, PhD study director
Director of Clinical Development Department, BIOCAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCD-256 and Divozilimab in people with Systemic Lupus Erthematosus, run by Biocad at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasiia S Admakina, MD (+ 7 (931) 311 90 49, admakina@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with adverse events (time frame: 85 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.