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Inebilizumab in Chinese Adult Patients With NMOSD
NCT06212245Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2024
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Hansoh Pharmaceutical Group
- Modality
- Monoclonal Antibodies
- Drugs
- inebilizumab
- Conditions
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
01
Overview
Phase 4, open-label, single-arm trial of inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD), sponsored by Hansoh Pharmaceutical Group. Primary endpoint: Percentage of participants with NMOSD attack determined by the investigator at Day 197. Planned start Feb 2024; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Inebilizumab
Participants will receive IV inebilizumab 300 mg
03
Who it enrols
Adult patients with AQP4-IgG positive NMOSD, EDSS <= 7.5, and a history of relapses requiring rescue therapy. Excludes patients with recent B-cell depleting therapy, HIV, Hepatitis B/C, or history of malignancy.
04
Endpoints
Primary
Percentage of participants with NMOSD attack determined by the investigator
Secondary
Percentage of participants with NMOSD attack determined by the investigator
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Laboratory measurements as well as their changes or shift as assessed by CTCAE v5.0
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