Vivacity-MG Myasthenia Gravis Clinical Trial Information for Medical Professionals

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Welcome to the VIVACITY-MG Study

Protocol MOM-Nipocalimab-M281-004

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Nipocalimab (M281) Administered to Adults with Generalized Myasthenia Gravis

About Nipocalimab (M281)

Nipocalimab (M281) is a fully human, anti-FcRn (neonatal Fc receptor), aglycosylated IgG1 monoclonal antibody. Nipocalimab (M281) has the potential of improving the clinical signs and symptoms of MG by blocking FcRn-mediated IgG recycling, thereby reducing pathogenic autoantibodies including the most common autoantibodies, anti-AChR and anti-MuSK. Nipocalimab (M281) is an investigational drug that is not approved by the U.S. Food and Drug Administration or any other regulatory agency. Its safety and effectiveness have not been demonstrated to date.

VIVACITY-MG Study Summary

Protocol MOM-Nipocalimab-M281-004 ( )
Phase 2
Patient Population Males and females 18 years of age or older
Diagnosis & Condition Diagnosed generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard of care therapy
Randomization Double-blind, placebo-controlled study
Five study drug groups (1:1:1:1:1)
  • Four of the five groups (80%) will receive the investigational drug
  • One of the five groups (20%) will only receive placebo
Method of Administration Intravenous infusions (approximately two hours per infusion)
Primary Objectives Assess the investigational drug’s:
  • Safety and tolerability
  • Efficacy as measured by the change in Myasthenia Gravis – Activities of Daily Living (MG-ADL) score
Length of Study Participation Approximately four months
  • Screening Period (up to 4 weeks)
  • Study Treatment Period (8 weeks)
  • Follow-up Period (8 weeks)
Open-Label Extension Study participants in the VIVACITY-MG Study may have the option to enroll in a long-term extension study, where they will all receive the investigational drug for an additional length of time at no cost.

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