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

Beijing Mabworks Biotech

Status and phase: Enrolling; Phase 3

Conditions: Neuromyelitis Optica Spectrum Disorder

Treatments: Other: Placebo; Drug: MIL62

Study type: Interventional

Funder types: Industry

Identifiers

NCT05314010

MIL62-CT303

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status.
2. Male or female aged 18～60 years.
3. Expanded Disability Status Scale(EDSS) score ≤6.5.
4. 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.
5. 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

1. 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).
2. Receipt of tocilizumab, eculizumab within 3 months prior to the first administration.
3. 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 .
4. Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration.
5. Any live or attenuated vaccine within 28 days prior to the first administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

MIL62

Experimental group

Treatment:

Drug: MIL62

Placebo

Placebo Comparator group

Treatment:

Other: Placebo