Health Condition 1: G360- Neuromyelitis optica [Devic]
Conditions
Interventions
Intervention1: BCD-132 (Divozilimab manufactured by JSC BIOCAD Russia): Eligible subjects will be randomized at a 2:1 ratio to the Divozilimab and placebo groups, respectively. For Divozilimab group
Sponsors
JSC BIOCAD Russia
In Vitro Research Solution Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Providing a written informed consent to participate in this clinical study. 2. Male and female patients aged = 18 years at the time of signing the informed consent form. 3. NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria. 4. Documented evidence of at least: • 1 relapse within 12 months before signing the informed consent form, or • 2 relapses within 24 months before signing the informed consent form. 5. A total EDSS score of = 7 (assessed by the evaluating neurologist). 6. Presence of IgG antibodies to the Varicella Zoster virus at screening. 7. A CD19+ cell proportion of = 1 % of the total lymphocyte count in patients exposed to other anti-B-cell therapies more than 6 months before signing the informed consent form. 8. In subjects of childbearing potential, from signing the informed consent form throughout the study and for 6 months after the last dose of the drug: • willingness of male and female subjects and their sexual partners to use reliable contraception methods; • refusal of female subjects to donate oocytes; • refusal of male subjects to donate sperm.
Exclusion criteria
Exclusion criteria: 1. A relapse occurring less than 30 days before signing the informed consent form or at screening 2. Intrathecal oligoclonal or monoclonal IgG production (only in patients who are anti-AQP4 seronegative). 3. Other nervous system disorders (including multiple sclerosis) that can mask or affect the assessment of NMOSD symptoms. 4. History of other autoimmune diseases requiring immunosuppressive therapy. 5. History of splenectomy. 6. Malignancies, including a history thereof, with the exception of cured basal cell carcinoma, cervical cancer in situ, as well as cured solid tumors with a remission of more than 5 years. 7. Historical evidence of progressive multifocal leukoencephalopathy (PML). 8. Existing severe comorbid somatic and psychiatric conditions making the patient ineligible for the study according to the Investigator. 9. Severe infections (requiring hospitalization, parenteral treatment with antibacterial, antimycotic, or antiprotozoal agents) within 30 days before signing the informed consent form and during the screening period. 10. Heart failure (NYHA class III/IV). 11. Existing HIV-infection, hepatitis B, hepatitis C, or syphilis. 12. History of tuberculosis or tuberculosis diagnosed at screening. 13. History of severe depression and/or a Beck Depression Inventory score of = 20 at screening. 14. History of allergy or severe reactions to components of the investigational products (e. g., premedication drugs), contraindications for the use of pre-treatment drugs, or anaphylaxis to biologics. 15. Prior exposure to: • alemtuzumab, total lymphatic irradiation or bone marrow transplantation (hematopoietic stem cell) at any time prior to signing the informed consent form;• anti-B-cell therapy drugs (rituximab, ocrelizumab, belimumab, ofatumumab, inebilizumab, etc.) or abatacept, satralizumab within 6 months prior to signing the informed consent form; • systemic corticosteroids at any dose at the time of signing the informed consent form;• mitoxantrone, cyclophosphamide, methotrexate, cyclosporine A, tacrolimus, eculizumab, tocilizumab, natalizumab, interferon beta, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate within 3 months before signing the informed consent form; • immunoglobulin products within 30 days before signing the informed consent form; • transfusion of blood or blood components within 30 days before signing the informed consent form. 16. Vaccination within 4 weeks prior to the planned date of the first administration of the investigational product in this clinical study (according to the patient). 17. Current alcohol, drug, or substance abuse or a history thereof. 18. Contraindications to MRI and/or gadolinium-based contrast agents. 19. Abnormal results of complete blood count (white blood cell count 2 × upper limit of normal [ULN] at screening, or an increase in ALT or AST activity to > 2.5 × ULN). 20. Pregnancy, breastfeeding, or planned pregnancy during the study participation and 6 months after the estimated date of the last dose of the investigational product. 21. Participation in other clinical studies of experimenta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of BCD-132 in comparison with placebo in subjects with neuromyelitis optica spectrum disorders (NMOSD) by the time to the first adjudicated relapse during the first 24 weeks of the studyTimepoint: 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of BCD-132 versus placebo in subjects with NMOSD in terms of secondary efficacy endpoints.Timepoint: 24 Weeks | — |
Countries
Belarus, India, Russian Federation
Contacts
Public ContactMr Vijaya Bhaskar
In Vitro Research Solutions iVRS Pvt Ltd
Outcome results
None listed