A Study of HBM9161 in NMOSD Patients

NCT04227470 | Completed Phase 1

• 1 other identifier: 9161.2
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

NMO Spectrum Disorder

Keywords

NMOSD

Outcome Measures

Primary Outcomes (1)

• Number of treatment related adverse events (AEs)

  Number of treatment related adverse events (AEs)

  189 days

Secondary Outcomes (8)

• Immunoglobins changes from baseline to week 27

  189 days

• Neurological Disability changes from baseline to week 27

  189 days

• Low Contrast Visual Acuity (LCVA) changes from baseline to week 27

  189 days

• Patient reported improvement changes from baseline to week 27

  189 days

• Percentage of patients who received rescue therapy

  189 days

Other Outcomes (3)

• Maximum change from baseline to week 27 in total serum AQP4-IgG concentrations

  189 days

• AQP4-IgG changes from baseline to week 27

  189 days

• HBsAb level changes from baseline to week 27

  189 days

Study Arms (2)

Experimental: HBM9161, 340mg

EXPERIMENTAL

HBM 9161 injection, 340mg, weekly administered by subcutaneous for a period of 4 weeks.

Drug: HBM9161 Injection

Experimental: HBM9161, 680mg

EXPERIMENTAL

HBM 9161 injection, 680mg, weekly administered by subcutaneous for a period of 4 weeks.

Drug: HBM9161 Injection

Interventions

HBM9161 Injection DRUG

Subcutaneous injection; Weekly administered for a period of 4 weeks. All subjects are treated with the testing drug, add on intravenous methylprednisolone (ivMP) with gradually reduce the dose then to oral prednisone. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued.

Experimental: HBM9161, 340mg; Experimental: HBM9161, 680mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No acute optic neuritis and/or transverse myelitis symptoms or signs.
• Severe NMOSD which may require plasmapheresis or intravenous immunoglobulin (IVIG) treatment, in opinion of investigator, very soon.
• Have received plasmapheresis or IVIG treatment, the last treatment dose/procedure is less than 4 weeks before visit 1.
• 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.
• Have received rituximab or other anti-CD20 drugs treatment within 6 months before visit 1.
• 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.
• Females who are pregnant or lactating.
• Patients who can't tolerate or have contraindication to high dose intravenous methylprednisolone per Investigator's opinion.
• 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.
• Patients have positive test result for HBsAg; or HBsAg negative meanwhile HBcAb positive and HBV-DNA level\>2000IU/mL.
• Serum total IgG \<700mg/dL at visit 1.
• Absolute neutrophil count \<1500个/mm3 at visit 1 and/or visit 2
• Patients with acute liver function impairment (e.g., hepatitis) or severe liver cirrhosis (Child-Pugh Score, Class C)
• Any malignant tumor.

Sponsors & Collaborators

• Harbour BioMed (Guangzhou) Co. Ltd.: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Wang J, Cai G, Xia S, Qin J, Liu B. Research hotspots and emerging topics in neuromyelitis optica spectrum disorder treatment: Insights from a bibliometric analysis. Medicine (Baltimore). 2025 Jun 6;104(23):e42850. doi: 10.1097/MD.0000000000042850.

  PMID: 40489809 DERIVED

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

HBM9161

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Wei Qiu

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose exploration study. Two dose groups (340 mg and 680 mg) were planned, 6 subjects at most for 340 mg group and 6 to 12 subjects for 680mg group. Each subject will only participate in one dose group. Escalation to the next dose level decided by PIs and sponsor after evaluating safety data and PD data for lower dose group.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: January 13, 2020
• Study Start: March 31, 2020
• Primary Completion: December 3, 2021
• Study Completion: December 24, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)