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