Chinese researchers are recruiting participants for a clinical study investigating the efficacy and safety of ofatumumab in patients with aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorder (NMOSD).
NMOSD is a demyelinating disorder that results in severe morbidity. Studies have indicated that its pathophysiology is primarily driven by a pathological B cell-mediated humoral immune response against AQP4.
One of the most important therapeutic goals in NMOSD is the prevention of relapses. Monoclonal antibodies against CD20 are a class of drugs that have demonstrated efficacy in this regard. Ofatumumab is a fully humanized anti-CD20 monoclonal antibody. Although it is already in use for multiple sclerosis, it has yet to be investigated for use in NMOSD.
This open-label, single-arm, multicenter interventional clinical study intends to enroll 5 participants to receive ofatumumab (20 mg/0.4 mL) subcutaneously at baseline, day 7, day 14, and monthly thereafter for a total of 48 weeks. The first 4 infusions will be carried out at study center sites, while subsequent infusions will be given at home with online guidance. This study has an estimated primary completion date of June 2024 and an estimated study completion date of December 2024.
Read more about NMOSD etiology
The study seeks to enroll patients with a diagnosis of AQP4-IgG-seropositive NMOSD, according to the 2015 International Panel Diagnostic Criteria, who have had at least 2 relapses in the past 24 and at least 1 relapse in the preceding 12 months. The participants must also have an Expanded Disability Status Scale (EDSS) score between 0 and 7.5.
The primary outcome measure is the change in annual relapse rate from baseline to the last follow-up visit. Secondary outcome measures include changes in EDSS score, lesion burden on magnetic resonance imaging T2-weighted images, optic coherence tomography measures, frequencies of circulating B cell subsets, and changes in the immune landscape.
Ofatumumab in AQP4-IgG seropositive NMOSD. ClinicalTrials.gov. August 17, 2022. Accessed August 18, 2022.