The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
HBM9161 Injection
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of AEs during the study
Incidence of AEs
Time frame: during the study，up to 24 weeks
Proportion of patients with sustained improvement
Sustained reduction defined as MG-ADL score improved by ≥ 3 points from baseline for at least 4 consecutive weeks during the 9-week treatment cycle
Time frame: during each treatment cycle (5-week treatment period + 4-week observation period, from the first dose of the cycle to Day 64 of the cycle)
During the 24-week study, proportion of time that MG-ADL improved from baseline by 3 or more points
Time frame: during the study，up to 24 weeks
Proportion of time remained in Minimal Symptom Expression
from baseline to Week 24, percentage of time MG-ADL score being 0 or 1
Time frame: during the study，up to 24 weeks
Improvement of patients' quality of life
Improvement of patients' quality of life
Time frame: during the study，up to 24 weeks
Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies
Incidence and duration of serum anti-HBM9161 antibodies and neutralizing antibodies
Time frame: during the study，up to 24 weeks
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