This research is being conducted to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of a humanized anti-human IL-6R neutralizing monoclonal antibody (SA237) in patients with Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD). This study is being conducted in the US and Canada and will enroll seventy (70) patients to participate in this research.
Mechanism of Action: SA237 is a humanized anti-human IL-6R neutralizing monoclonal antibody that was designed by applying recycling antibody technology to the approved anti-IL6 receptor antibody, tocilizumab, which is currently marketed as a treatment for rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and Castleman’s disease. The recycling antibody technology enabled SA237 to bind to IL-6 receptor multiple times and be slowly cleared from plasma, which is expected to contribute to improvement and is convenient with once monthly dosing frequency.The longer plasma half-life of SA237 compared with tocilizumab was confirmed based on the results of a non-clinical study and a Phase 1 study in healthy volunteers.
This study is not currently open for recruitment.
NMO or NMOSD
Age 18 to 74 years, inclusive at the time of informed consent.
Pregnancy or lactation.
Evidence of other demyelinating disease or PML.
Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
If you are interested in participating, please contact: