Clinical Research Directory

Inclusion (key) * Confirmed generalized MG: Diagnosis ≥6 months before screening, anti-AChR antibody positive, and supportive diagnostic evidence (e.g., abnormal SFEMG/RNS or response to anticholinesterase therapy). * Disease severity: MGFA Class II-IV at screening. * Symptoms threshold: MG-ADL ≥6 at screening and on Day 1. * Meningococcal vaccination: Up to date within 3 years or vaccinated before first dose to mitigate risk with complement inhibition. * Body weight: ≥40 kg. * Vaccinated against meningococcal infections within the 3 years prior to, or at the time of, initiating study drug. Exclusion (key) * Thymic disease: * Untreated thymic malignancy/carcinoma/thymoma excluded. * Prior thymic malignancy allowed only if treatment completed \>5 years, no recurrence in last 5 years, and clear CT/MRI within 6 months. * Prior benign thymoma allowed if confirmed benign, treatment \>12 months ago, no recurrence in last 12 months, and clear CT/MRI within 6 months; otherwise follow malignancy rules. * Thymectomy within the last 12 months * Infection risk: * History of meningococcal disease or unresolved infection, or active systemic infection within 14 days of Day 1 excluded. * Persistent/recurrent infections in past 12 months that add risk * HIV, active HBV (HBsAg+ or anti-HBc+ with anti-HBs-), or active HCV (unless documented successful treatment/SVR) * Safety/medical status: * Hypersensitivity to study drug components (including murine proteins) * Recent hospitalization ≥24 hours within 28 days of screening * Substance use disorder per DSM within 12 months. * Recent/other malignancy within 5 years (except as above for thymic). * Prior/Concomitant Therapy * Complement inhibitor within \< 5 half-lives before Day 1. * Human neonatal Fc receptor (FcRn) inhibitor within \< 5 half-lives before Day 1. * Rituximab, ocrelizumab or other B cell-depleting therapy within ≤ 6 months (180 days) before Day 1. * Periodic (chronic) administration of PP/PE, or IVIg as maintenance therapy received or scheduled within ≤ 6 months before Day 1 * Key labs: * ALT \>2× ULN, direct bilirubin \>2× ULN. * eGFR \<30 mL/min/1.73 m² or on dialysis. * Any other clinically significant lab abnormality making participation unsafe. Note: Other protocol-defined criteria may apply and should be verified during full eligibility review.