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

B

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

140 participants in 2 patient groups, including a placebo group

MIL62
Experimental group
Treatment:
Drug: MIL62
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Dehui Huang, doctor

Data sourced from clinicaltrials.gov

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