Clinical Trials Logo

Clinical Trial Summary

Primary Objectives:To investigate the safety and tolerability of HBM 9161 in patients with attack of NMOSD in China


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04227470
Study type Interventional
Source Harbour BioMed (Guangzhou) Co. Ltd.
Contact
Status Completed
Phase Phase 1
Start date March 31, 2020
Completion date December 24, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05154734 - Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders Phase 1/Phase 2
Withdrawn NCT03829566 - Autologous Transplant To End NMO Spectrum Disorder Phase 2/Phase 3
Recruiting NCT05403138 - Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders Phase 2/Phase 3
Completed NCT05432713 - A Study of LP-168 in Healthy Volunteers Phase 1
Not yet recruiting NCT04822623 - Imaging Evaluation of Central Nervous Autoimmune Diseases
Not yet recruiting NCT06280755 - Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
Recruiting NCT05414890 - Sensitivity and Specificity of TSA-CBA for Autoantibodies Against Neural Antigen Determination
Recruiting NCT05840055 - ACT With NMOSD Patients and Caregivers Pilot Study N/A
Recruiting NCT05004493 - Biorepository and Registry for Plasma Exchange Patients
Completed NCT05896605 - Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder Phase 4
Recruiting NCT04106830 - Clinical and Imaging Patterns of Neuroinflammation Diseases in China (CLUE)
Completed NCT03766347 - Pediatric NMOSD Observational Study
Recruiting NCT05154370 - China National Registry of Neuro-Inflammatory Diseases
Recruiting NCT06443333 - National, Multicentric Registry Study on Neuroimmunological Diseases in China
Recruiting NCT05145361 - Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) Early Phase 1
Not yet recruiting NCT05974293 - A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders Phase 2
Completed NCT04355611 - Epidemiological Characteristics of COVID-19 in Patients With MS or NMO
Recruiting NCT05792462 - Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders Phase 1/Phase 2