Vivacity MG Phase 3 Study: Clinical Trial of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Objective We describe Vivacity-MG3. our pivotal Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Nipocalimab Administered Adults With gMG ( NCT04951622 ). Background is a high affinity, fully human, aglycosylated, effectorless IgG1 anti FcRn monoclonal antibody that targets neonatal Fc receptor (FcRn) with thereby lowering IgG pathogenic antibodies in autoimmune disease. Data from Vivacity-MG, 2 randomized placebo-controlled study nipocalimab adult generalized myasthenia gravis (gMG), demonstrated safety, tolerability, efficacy clinicaltrials.gov NCT03772587 Design/Methods This global will enroll approximately 180 participants gMG, aged 18 older, an insufficient clinical response ongoing, stable standard-of-care therapy, as reflected by Myasthenia Gravis-Activities Daily Living (MG-ADL) score >/= 6 at screening baseline, Gravis Foundation America (MGFA) Class IIa/b–IVa/b screening. The consist period up 4 weeks, 24-week double-blind phase where be randomly assigned 1:1 ratio receive either placebo or intravenously every two open label extension variable duration. primary outcome average change MG-ADL baseline weeks 22, 23 24 phase. Results enrollment began July 2021 ongoing. Conclusions ongoing Vivacity MG 3 assess efficacy, PK/PD gMG.