Vibrance-mg: Clinical Trial of Nipocalimab in Pediatric Myasthenia Gravis

Abstract

Nipocalimab is a high affinity, fully human, aglycosylated, effectorless IgG1 anti neonatal Fc receptor (FcRn) monoclonal antibody that targets FcRn with high affinity, thereby lowering IgG pathogenic antibodies in autoimmune disease. Data from Vivacity‐MG, a phase 2, multicenter, randomized, double‐blind, placebo‐controlled study of nipocalimab demonstrated safety, tolerability, and efficacy of nipocalimab in adult generalized myasthenia gravis (gMG) (clinicaltrials.gov NCT03772587). We describe an openlabel study (Vibrance‐MG) of nipocalimab to determine the effect of nipocalimab in pediatric participants with gMG. METHODS: This global study will enroll at least 12 participants, aged 2 to <18, with a diagnosis of gMG and an insufficient clinical response to ongoing, stable standard‐ofcare therapy, as reflected by a Myasthenia Gravis Foundation of America Class of IIa/b‐IVa at screening. Participants must have a positive serologic test for either acetylcholine receptor or muscle specific tyrosine kinase pathogenic autoantibody. The study will consist of a screening period of up to 4 weeks, a 24‐week open‐label active treatment phase where participants will receive IV nipocalimab every 2 weeks, and a longterm extension phase; after the last dose, a safety followup assessment will be conducted at 8 weeks. The primary outcome is the effect of nipocalimab on total serum IgG, safety and tolerability, and pharmacokinetics in pediatric participants with gMG. RESULTS: Study enrollment will begin in 2022. SUMMARY/CONCLUSION: The Vibrance‐MG study will assess the pharmacokinetics/pharmacodynamics, safety, and activity of nipocalimab in pediatric gMG.