To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
Confirmed NMOSD patients;
Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
The blood pregnancy tests were negative within 7 days before the first dose in fertile female subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;
Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures.
Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
Subjects with chronic active immune system diseases undergoing systematic treatment;
Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
Received the prescribed drug treatment at the prescribed time before first dose;
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborator