An international multicenter, randomized, double-blind, parallel-group study of the comparative pharmacokinetics, safety, and immunogenicity of MIT-004, a concentrate for preparing an infusion solution, 30 mg/ml in patients with multiple sclerosis.

Multiple sclerosis (MS) is a chronic neurological condition characterized by a focal and diffuse autoimmune inflammatory process, demyelination, and neurodegeneration in the central nervous system with high clinical and pathological heterogeneity. Depletion of the B-cell pool plays an important role in suppressing inflammation in MS. B lymphocytes are involved in the pathogenesis of MS, as they can secrete cytokines, selectively present antigens to T cells and produce antibodies together with plasma cells, and meningeal lymphoid follicles can be associated with cortical demyelination and axon loss. At the same time, B cells are involved in cell growth, remodeling and repair. Moreover, regulatory B cells play an important role in fighting excessive inflammation. Therapeutic monoclonal antibodies are playing an increasingly important role in the treatment of MS, being one of the most effective therapies available. One of the promising monoclonal anti bodies is ocrelizumab, a molecule of which is derived from a mouse anti-CD20 antibody and hu manized by recombination methods. Ocrelizumab’s IgG1 tail is capable of binding to a specific CD20 epitope. The target molecule (CD20) is a glycosylated phosphoprotein that is expressed in the vast majority of B lymphocyte lines: pre-B cells, mature and immature B cells, and memory cells. As a result of exposure to ocrelizumab, the B cell population decreases by three main mech anisms: antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and apop tosis. In addition, ocrelizumab also acts on a subtype of circulating T cells that express CD20, which accounts for ~6% of the total number of T cells.