This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
Phase 1b: Participants will receive intravenous (IV) infusions of MIL62 at doses of 500 mg or 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, W79D1, W105D1, W131D1, W157D1, W183D1, and W209D1. Participants initially assigned to the 500 mg dose group who exhibit good tolerance may be escalated to the 1000 mg dose starting from W25D1. Phase 3 (Randomised Controlled Period \[RCP\]): Participants will receive IV MIL62 1000 mg or placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1. The administration protocol for placebo is identical to that of MIL62. Phase 3 (Open-Label Period \[OLP\]): Participants who enter the OLP will receive IV MIL62 1000 mg on W1D1, W27D1, W53D1, W79D1, W105D1, and W131D1, along with matching placebo on W3D1.
Phase 3 (RCP): Participants will receive IV placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1. Phase 3 (OLP): Participants entering the OLP will receive IV MIL62 1000 mg on W1D1, W3D1, W27D1, W53D1, W79D1, W105D1, and W131D1.
Ethics Committee of Chinese PLA General Hosptial
Beijing, Beijing Municipality, China
Phase 1b: The incidence and severity of all adverse events (AE)
Time frame: Up to Week 234
Phase 3: Time to First Adjudicated Relapse (TFR) during RCP.
The time from the date of randomization to the date of the first clinical relapse as assessed by the Clinical Endpoint Committee(CEC). The criteria for NMOSD relapse are the occurrence of new objective neurological symptoms or worsening of objective neurological symptoms; meeting any one of the relapse criteria specified in the protocol is sufficient.
Time frame: Up to 52 weeks
Time to first adjudicated relapse
Time frame: Up to Week 208
Annualized relapse rate
Time frame: Up to Week 208
Change from baseline of Expanded Disability Status Scale (EDSS) score
Time frame: Up to Week 208
Annualized cumulative active lesions rate on MRI
Time frame: Up to Week 208
Annualised NMOSD-related inpatient hospitalisation rate.
Time frame: Up to Week 208
Mean Change in T-score from Baseline in the EQ5D Scale.
Time frame: Up to Week 208
Percentage of Participants with Adverse Events (AEs).
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Up to Week 208
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Peripheral B-cell Counts at Specified Timepoints.
Time frame: Up to Week 208