Neuromyelitis optica spectrum disorders
Conditions
Interventions
Case series:HBM9161
Sponsors
The Third Affiliated Hospital,Sun Yat-Sen Unvierity
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. In Visit 1, male or female aged >=18 years; 2. Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 3. Core clinical manifestiations 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; 4. The EDSS score of patients should be fall in the range of 3.5 to 7.5 at visit 1; 5. AQP4-IgG is positive at visit 1 or had AQP4-IgG positive medical records before visit; 6. Be able to recognize English letters; 7. Patients should be on stable treatement of the following medications before visit 1(if anyone had a stable treatment): 7.1 Immunosuppressant or immunomodulatory drugs; 7.1.1 Azathioprine must be initiated at least 12 months ago and remain stable dosage for at least 4 months before screening; 7.1.2 Others (for example, mycophenolate mofetil, cyclosporine, methotrexate and tacrolimus) must be initiated at least 6 months ago and remain stable dosage for at least 3 months before screening; 7.2 Corticosteroids: At screening, the dose must be stable for at least 1 month; 7.3 If patients received plasmapheresis or IVIg treatment, the last treatment dose/procedure must be finished at least 4 weeks before screening.
Exclusion criteria
Exclusion criteria: 1. No acute optic neuritis and/or transverse myelitis symptoms or signs; 2. Severe NMOSD which may require plasmapheresis or intravenous immunoglobulin (IVIG) treatment, in opinion of investigator, very soon; 3. Have received plasmapheresis or IVIG treatment, the last treatment dose/procedure is less than 4 weeks before visit 1; 4. Have known autoimmune diseases other than NMOSD that would interfere with efficacy assessment or participation in this study (such as uncontrolled thyroid disease or severe rheumatoid arthritis), or have any comorbid diseases which would interfere with the efficacy evaluation of HBM9161 on NMOSD; 5. Have received rituximab or other anti-CD20 drugs treatment within 6 months before visit 1; 6. Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months before visit 1 or within 5 half-life periods of the drug; 7. Females who are pregnant or lactating; 8. Patients who can't tolerate or have contraindication to high dose intravenous methylprednisolone per Investigator's opinion; 9. Have an active infection at visit 1, or a recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) within 8 weeks before visit 1; or history of or existing infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HBV surface antigen, HBV core antibody, HCV antibody, HIV 1 and 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined) at visit 1; 10. Serum total IgG <700mg/dL at visit 1; 11. Absolute neutrophil count <1500/mm3 at visit 1 and/or visit 2; 12. Patients with acute liver function impairment (e.g., hepatitis) or severe liver cirrhosis (Child-Pugh Score, Class C); 13. Any malignant tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| EDSS;PGI-I;Change of concentration of immunoglobins;Percentage of patients who received rescue therapy;Low Contrast Visual Acuity;Percentage of patients who have relapse;Walking ability;The seropositive rate of anti-HBM9161 antibody; | — |
Countries
China
Contacts
Public ContactMeng Wang
Harbour BioMed (Guangzhou) Co., Ltd
Outcome results
None listed