Phase 3 Study to Assess Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)

Prior treatment

• Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
• Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies, etc.) within the past year.
• Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.

Other illness

• Have any active or untreated malignant thymoma.

Other

• Have experienced myasthenic crisis within 3 months of the Screening Visit.
• Additional exclusion criteria are defined in the protocol.

• Are ≥ 18 years of age at the Screening Visit.
• Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
• Have a QMG score ≥ 11 at the Screening and Baseline Visits.
• Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
• Additional inclusion criteria are defined in the protocol.