Overview
The goal of this clinical trial is to study the efficacy and safety of BCD-132 (divozilimab) in subjects with neuromyelitis optica spectrum disorders (NMOSD).
Description
BCD-132-6/AQUARELLE is a randomized, double-blind, placebo-controlled phase 3 clinical study in subjects with NMOSD. Eligible subjects will be randomized at a 2:1 ratio to the divozilimab and placebo groups, respectively. At randomization, subjects will be stratified according to the presence of anti-AQP4 antibodies and number of relapses during the past 12 months. Approximately 105 subjects will be enrolled.
The study consists of a screening period, a treatment period (Stage 1 and Stage 2), and a follow-up period.The maximum duration of Stage 1 will be about 24 weeks. During Stage 1, the subjects will receive one dose of the investigational product (divozilimab/placebo). During Stage 2, all subjects (both in the divozilimab and placebo groups) will receive therapy with divozilimab.
The duration of participation for each subject will be approximately 56 weeks.
Eligibility
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