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Primary Objectives:To investigate the safety and tolerability of HBM 9161 in patients with attack of NMOSD in China
Full description
This is an open-label, dose exploration study.The investigational drug is HBM9161 injection, and the indication is NMOSD.
HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . By blocking the FcRn IgG-Fc binding site and accelerating the degradation of IgG, it can significantly reduce the total IgG level in blood (including pathological IgG).The serum aquaporin 4 antibody (AQP4-IgG) associated with NMOSD is a pathological IgG, so the combination of standard of care which is intravenous methylprednisolone (ivMP) with HBM9161 is expected to rapidly reduce AQP4-IgG levels.
Two dose groups (340 mg and 680 mg) were planned, and each dose group plans to enroll approximately 6 subjects. All subjects are weekly administered the HBM9161 by subcutaneous injection for a period of 4 weeks, together with standard of care which is of intravenous methylprednisolone (ivMP) by subcutaneous for a period of 4 weeks. The study will investigate the safety, and tolerability, pharmacodynamics and efficacy of HBM 9161 in patients with attack of NMOSD in China.
Enrollment
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Inclusion criteria
In visit 1, Male or female aged ≥ 18 years.
Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
Core clinical manifestations characterized by new acute optic neuritis and/or transverse myelitis. A clinical event is defined as an episode of inflammation in the spinal cord and/or optic nerve leading to neurologic deficits which can be identified by physical examination and not attributable to another disease process.
The EDSS score should be ≥ 2.5 and ≤7.5 at visit 1.
AQP4-IgG is positive at visit 1 or had AQP4-IgG positive medical records before visit 1.
Be able to recognize English letters.
Patients should be on stable treatment of the following medications before screening (if anyone had a stable treatment ):
Immunosuppressant or immunomodulatory drugs (for example, azathioprine, cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate and so on) must be stable for at least 8 weeks before screening and keep stable during study
• Corticosteroids
At screening, the treatment dose must be stable for at least 1 month. • If patients accepted plasmapheresis or IVIg treatment, the last treatment dose/procedure must be finished at least 4 weeks ago before screening
Exclusion criteria
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9 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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