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

Last updated: May 14, 2025
Sponsor: Beijing Mabworks Biotech Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Treatment

Placebo

MIL62

Clinical Study ID

NCT05314010
MIL62-CT303
  • Ages 18-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 lastyear 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 12weeks in which their relapse symptoms are stable prior to the first administration.

Exclusion

Exclusion Criteria:

  1. CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab orany B-cell depleting agent within the 6 months prior to screening, unless thesubject has B-cell counts above the LLN. CD4 T lymphocyte count <300cells/μL(CD4:CD8≤1.4).

  2. Receipt of tocilizumab, eculizumab within 3 months prior to the firstadministration.

  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 thehalf-life of the drug before they could get into the group .

  4. Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to thefirst administration.

  5. Any live or attenuated vaccine within 28 days prior to the first administration.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 18, 2022
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Ethics Committee of Chinese PLA General Hosptial

    Beijing, Beijing
    China

    Active - Recruiting

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