The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
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Subjects with generalized myasthenia gravis;
Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
MG-ADL ≥5 at screening and baseline;
Subjects with MGFA I and V type;
Subjects usingprescribed drugs;
Subjects with a prescribed disease or history of disease;
The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
Parallel
B007
DrugB007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15
Placebo
DrugB007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
Proportion of subjects：MG-ADL decreased by ≥2
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
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
Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.
Changes in MGQoL15r from baseline.
Changes in MGC (Myasthenia gravis composite) from baseline.
Changes in MGC from baseline
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Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborator
