Vivacity-MG: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis (2157)
Jeffrey T. Guptill, Carlo Antozzi, Vera Bril, Josep Gámez, Sven G. Meuth, J.L. Muñoz Blanco, Richard J. Nowak, Dianna Quan, Teresa Sevilla, Andrzej Szczudlik, Brooke Hegarty, Marie‐Hélène Jouvin, Jim Y. Jin, Santiago Arroyo
Abstract
To evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of nipocalimab vs. placebo in patients with generalized myasthenia gravis (gMG) who have had an insufficient response to ongoing, standard-of-care therapy.
Topics & Concepts
TolerabilityImmunogenicityPharmacokineticsMedicinePlaceboPharmacodynamicsDouble blindMyasthenia gravisPharmacologyInternal medicineAdverse effectAntibodyImmunologyPathologyAlternative medicineMyasthenia Gravis and ThymomaCancer Treatment and Pharmacology