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;
Parallel
SHR-2173 injection
DrugSHR-2173 injection；High dose
SHR-2173 injection
DrugSHR-2173 injection；Low dose
Placebo
DrugPlacebo
Change from baseline in MG-ADL total score
Change from baseline in Quantitative Myasthenia Gravis (QMG) score
Change from baseline in Myasthenia Gravis Composite (MGC) total score
Change from baseline in MG-ADL domain scores (ocular, bulbar, respiratory, limb)
Change from baseline in QMG domain scores (ocular, bulbar, respiratory, limb)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
