A new phase 3 clinical trial testing the safety and efficacy of BCD-132 (divozilimab) in patients with neuromyelitis optica spectrum disorder (NMOSD) is now recruiting participants in Russia.
The randomized, double-blind, placebo-controlled trial sponsored by Biocad, which aims to recruit 105 patients, consists of 3 periods: a screening period, a treatment period, and a follow-up period lasting a total of around 56 weeks.
Read more about NMOSD diagnosis
After the screening period, participants will either receive an intravenous infusion of BCD-132 or a placebo for 24 weeks. This will be followed by the second stage of the treatment period in which all participants will receive BCD-132.
The primary outcome measure of the study is the time to the first adjudicated relapse within the first 24 weeks. Secondary outcome measures are the adjudicated annualized relapse rate, the proportion of participants without adjudicated relapses and a confirmed increase in disability, any change in the Expanded Disability Status Scale (EDSS) score, acuity of vision, timed 25-foot walk test, the severity of pain, and quality of life, and the cumulative number of new Gd-enhancing T1-weighted lesions and new T2-weighted lesions or enlarging T2-weighted lesions.
Participants, who are 18 years of age and older, who are diagnosed with NMSOD and have documented evidence of 1 or more relapses within the last year and an EDSS score of 7 or less are eligible to take part in the trial. The full inclusion and exclusion criteria can be found on the trial site.
The study started on December 12, 2022, and is estimated to be completed in April 2025.
NMOSD is a rare autoimmune disease of the central nervous system characterized by bilateral optic neuritis affecting the optic chiasm with visual loss. Other symptoms include anorexia, hypothermia, and hypersomnia.
BCD-132 is humanized monoclonal antibody against anti-CD20.
Efficacy and safety of divozilimab in patients with neuromyelitis optica spectrum disorders (AQUARELLE). US National Library of Medicine. Updated February 21, 2023. Accessed February 23, 2023.