This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of SHR-2173 compared to placebo as an add-on therapy to standard of care (SOC) for the treatment of generalized myasthenia gravis (gMG). The study consists of a 4-week screening period, a 24-week treatment period, and a 12-week safety follow-up period.
Male and female participants aged 18-75 years, confirmed diagnosis of generalized myasthenia gravis (gMG) (Myasthenia Gravis Foundation of America [MGFA] class II-IV).
Positive for anti-AChR antibody or anti-MuSK antibody.
MG-ADL total score ≥5 at screening and baseline, with >50% of the score attributable to non-ocular items.
QMG score ≥11 at screening and baseline.
Any untreated thymic epithelial tumor, mediastinal germ cell tumor, or other malignant mediastinal mass; or any thymic cyst or other mass requiring immediate intervention per investigator judgment;
Previous history of thymic tumor not meeting protocol requirements;
Myasthenic crisis (MGFA Class V) within 3 months prior to randomization;
Any known disease other than gMG that may interfere with study procedures and assessments;