NMO Spectrum Disorder Clinical Trial
Official title:
Safety, Tolerability, Pharmacodynamics and Efficacy of HBM9161 Weekly Subcutaneous Administration in Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD) in China
Verified date | January 2022 |
Source | Harbour BioMed (Guangzhou) Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary Objectives:To investigate the safety and tolerability of HBM 9161 in patients with attack of NMOSD in China
Status | Completed |
Enrollment | 9 |
Est. completion date | December 24, 2021 |
Est. primary completion date | December 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 should be = 2.5 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 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: 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 active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) within 8 weeks before screening; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined) at visit 1. 10. Patients have positive test result for HBsAg; or HBsAg negative meanwhile HBcAb positive and HBV-DNA level>2000IU/mL. 11. Serum total IgG <700mg/dL at visit 1. 12. Absolute neutrophil count <1500?/mm3 at visit 1 and/or visit 2 13. Patients with acute liver function impairment (e.g., hepatitis) or severe liver cirrhosis (Child-Pugh Score, Class C) 14. Any malignant tumor. |
Country | Name | City | State |
---|---|---|---|
China | Nanfang Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Harbour BioMed (Guangzhou) Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Maximum change from baseline to week 27 in total serum AQP4-IgG concentrations | Maximum change from baseline in total serum AQP4-IgG concentrations | 189 days | |
Other | AQP4-IgG changes from baseline to week 27 | Change of serum concentration of AQP4-IgG overtime after administration of HBM9161 from baseline to week 27 | 189 days | |
Other | HBsAb level changes from baseline to week 27 | Change in HBsAb level overtime after administration of HBM9161 from baseline to week 27 | 189 days | |
Primary | Number of treatment related adverse events (AEs) | Number of treatment related adverse events (AEs) | 189 days | |
Secondary | Immunoglobins changes from baseline to week 27 | Change of concentration of immunoglobins in mg/ml overtime after administration of HBM9161 from baseline to week 27 | 189 days | |
Secondary | Neurological Disability changes from baseline to week 27 | Neurological Disability changes from baseline to week 27 as measured by Expanded Disability Scale Score (EDSS, Score 0-10, higher means a worse outcome) | 189 days | |
Secondary | Low Contrast Visual Acuity (LCVA) changes from baseline to week 27 | Low Contrast Visual Acuity (LCVA) changes from baseline to week 27 as measured by Sloan Low Contrast Letter Scale (SLCLS Letter, Score 0-70, higher means a better outcome) | 189 days | |
Secondary | Patient reported improvement changes from baseline to week 27 | Patient reported improvement changes from baseline to week 27 as measured by Patient Global Impression-Improvement (PGI-I, Score 1-7, higher means a worse outcome) | 189 days | |
Secondary | Percentage of patients who received rescue therapy | Percentage of patients who received rescue therapy | 189 days | |
Secondary | Percentage of patients who have relapse | Percentage of patients who have relapse | 189 days | |
Secondary | Walking ability changes from baseline to week 27 | Walking ability changes from baseline to week 27 as measured by time used for 25-foot Walk (applicable for patients who are able to walk) | 189 days | |
Secondary | The seropositive rate of anti-HBM9161 antibody after treatment | Evaluation of the seropositive rate of anti-HBM9161 antibody after treatment | 189 days |
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 |