A Study of HBM9161 in NMOSD Patients

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harbour BioMed (Guangzhou) Co. Ltd.

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 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.

4. The EDSS score of patients should be ≥ 3.5 and ≤7.5 at visit 1.

5. AQP4-IgG is positive at visit 1 or had AQP4-IgG positive medical records before visit 1.

6. Be able to recognize English letters.

7. Patients should be on stable treatment of the following medications before visit 1(if anyone had a stable treatment ):

• Immunosuppressant or immunomodulatory drugs

• Azathioprine must be initiated at least 12 months ago and remain stable dosage for at least 4 months before screening.

• Others (for example, cyclophosphamide, cyclosporin A, tacrolimus, mycophenolate mofetil and methotrexate) must be initiated at least 6 months ago and remain stable dosage for at least 3 months before screening.

• Corticosteroids

• At screening, the treatment dose must be stable for at least 1 month.

• If patients received plasmapheresis or IVIg treatment, the last treatment dose/procedure must be finished at least 4 weeks ago before screening.

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个/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.