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A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
Sponsor: RemeGen Co., Ltd.
Summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
Official title: A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2018-01-29
Completion Date
2026-04-03
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Placebo
Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
RC18 160 mg
In the Phase B,the researchers can adjust the dose of RC18 according to the subjects' willingness and recurrence, but the maximum dose of single dose should not exceed 320g.
Locations (1)
Beijing Hospital
Beijing, Beijing Municipality, China