Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE) (AQUARELLE)
Neuromyelitis Optica Spectrum Disorders
About this trial
This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorders
Eligibility Criteria
Inclusion Criteria: NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria 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 A total EDSS score of ≤ 7 Presence of IgG antibodies to the Varicella Zoster virus at screening 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 Exclusion Criteria: A relapse occurring less than 30 days before signing the informed consent form or at screening (patients may be re-screened) Intrathecal oligoclonal or monoclonal IgG production (in patients who are anti-AQP4 seronegative) Other nervous system disorders (including multiple sclerosis) that can mask or affect the assessment of NMOSD symptoms History of other autoimmune diseases requiring immunosuppressive therapy Prior exposure to: alemtuzumab, total lymphatic irradiation, bone marrow transplantation; anti-B-cell therapy drugs, abatacept, satralizumab within 6 months prior to 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; systemic corticosteroids at the time of signing the informed consent form
Sites / Locations
- Llc "Profimed"Recruiting
- Municipal Autonomous Healthcare Institution of the Order of the Red Banner of Labor "City Clinical Hospital No.1"Recruiting
- Regional Clinical Hospital No.3Recruiting
- Kuzbass Clinical Hospital named after S.V. BelyaevRecruiting
- Khanty-Mansiysk autonomous district - Ugra "The district clinical hospital"Recruiting
- Center for Cardiology and NeurologyRecruiting
- Regional Clinical Hospital № 1 named after Professor S. V. OchapovskyRecruiting
- Moscow Regional Clinical Research Institute named after M.F. Vladimirsky (MONIKI)Recruiting
- Semashko Regional Clinical HospitalRecruiting
- LLC "Medis"Recruiting
- State Novosibirsk Regional Clinical HospitalRecruiting
- Pyatigorsk City Clinical Hospital No.2Recruiting
- Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"Recruiting
- Pavlov First Saint Petersburg State Medical UniversityRecruiting
- Seredavin Regional Clinical HospitalRecruiting
- Republican Clinical Hospital No.4Recruiting
- Siberian State Medical UniversityRecruiting
- Medical and Sanitary Unit "Neftyanik"Recruiting
- Ulyanovsk Regional Clinical HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BCD-132 (divozilimab)
Placebo
Stage 1 and 2 - Intravenous infusion of BCD-132 every 24 weeks
Stage 1 - Intravenous infusion of Placebo; Stage 2 - Intravenous infusion of BCD-132