Neuromyelitis Optica Spectrum Disorders Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders
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).
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. ;
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