A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.

Official Title
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A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Conditions
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Neuromyelitis Optica Spectrum Disorder

Intervention / Treatment
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* Drug: MIL62
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status. Male or female aged 18～60 years. Expanded Disability Status Scale(EDSS) score ≤6.5. A documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening. Subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration. Exclusion Criteria: CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab or any B-cell depleting agent within the 6 months prior to screening, unless the subject has B-cell counts above the LLN. CD4 T lymphocyte count <300 cells/μL(CD4：CD8≤1.4). Receipt of tocilizumab, eculizumab within 3 months prior to the first administration. Receipt of any of the following prior to the first administration: Azathioprine,Mycophenolate mofetil,Tacrolimus,Cyclosporin, Methotrexate,Cyclophosphamide,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group . Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration. Any live or attenuated vaccine within 28 days prior to the first administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIL62<br> | Drug: MIL62<br>* Phase 1b:participants will receive IV MIL62 500 mg or 1000 mg on Day 1 and Day 15. Phase 3:Participants will receive IV MIL62 on Day 1, Day 15 and Day 183 of the RCP at the dose confirmed in the phase Ib. The participants who enter the OLP will receive IV MIL62 on Day 1 and matching placebo on Day 15, followed by a single IV dose of MIL62 every 6 months until maximum of 6 months after the last participant enters the OLP.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Phase 3:Participants will receive IV placebo matched to MIL62 on Day 1, Day 15 and Day 183 of the RCP. The participants who enter the OLP will receive IV MIL62 on both Day 1 and Day 15, followed by a single IV dose of MIL62 every 6 months until maximum of 6 months after the last participant enters the OLP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1b: CD19+ B and CD20+ B lymphocyte ratio | Pharmacodynamics endpoint | Up to 52 weeks | 
| Time to Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP | The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD | Up to 52 weeks |