To assess the efficacy and safety of Inebilizumab in Chinese adult patients with neuromyelitis optica spectrum disorders.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Participants will receive IV inebilizumab 300 mg
IRB of Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Percentage of participants with NMOSD attack determined by the investigator
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide.
Time frame: Day 1 (Baseline) through Day 197
Percentage of participants with NMOSD attack determined by the investigator
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide.
Time frame: Day 1 (Baseline) through Day 379
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score
TEDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.were measured by MRI of the brain, optic nerve, and spinal cord.
Time frame: Day 1 (Baseline) through Day 379
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions
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The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.
Time frame: Day 1 (Baseline) through Day 379
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
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention.
Time frame: Day 1 (Baseline) through Day 379