The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Peking University First Hospital
Beijing, China
RECRUITINGProportion of subjects:MG-ADL(Myasthenia gravis-activities of daily living profile) decreased by ≥2
Proportion of subjects:MG-ADL decreased by ≥2
Time frame: Approximately 16 weeks
Proportion of subjects:subjects without SoC(Standard of Care) change and MG-ADL decreased by ≥2
Proportion of subjects:subjects without SoC change and MG-ADL decreased by ≥2
Time frame: Approximately 24 weeks
Proportion of subjects:subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3
Proportion of subjects:subjects without SoC change and QMG decreased by ≥3
Time frame: Approximately 24 weeks
Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.
Changes in MGQoL15r from baseline.
Time frame: Approximately 24 weeks
Changes in MGC (Myasthenia gravis composite) from baseline.
Changes in MGC from baseline
Time frame: Approximately 24 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Time frame: Approximately 1 years
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