Phase
Condition
Multiple Sclerosis
Treatment
Placebo
MIL62
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 lastyear 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 12weeks in which their relapse symptoms are stable prior to the first administration.
Exclusion
Exclusion Criteria:
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).
Receipt of tocilizumab, eculizumab within 3 months prior to the firstadministration.
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 .
Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to thefirst administration.
Any live or attenuated vaccine within 28 days prior to the first administration.
Study Design
Connect with a study center
Ethics Committee of Chinese PLA General Hosptial
Beijing, Beijing
ChinaActive - Recruiting
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