SUMMARY

• Nipocalimab is an investigational, fully human, high-affinity, aglycosylated, effectorless immunoglobulin G1 (IgG1) anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody that is being studied for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients.^1-3

PHASE 2/3 CLINICAL PROTOCOLS

VIVACITY-MG3 and Vibrance-mg Clinical Trials

Vu et al (2024)¹  evaluated the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of nipocalimab in adults with gMG in a phase 3, randomized, multicenter, double-blind, placebo-controlled study (VIVACITY-MG3).

Ramchandren et al (2022)^4,5 is evaluating the safety, efficacy, PK, and PD of nipocalimab in children and adolescents aged 2 to <18 years with gMG who have an insufficient response to ongoing, stable standard of care therapy in an ongoing, open-label, uncontrolled multicenter clinical trial (Vibrance-mg).

Management of Infusion-Related Reactions

Per study protocols, an infusion reaction is defined as any adverse event (AE) that is reported by investigators to represent an infusion reaction. Minor infusion-related AEs may be managed by slowing the rate of the intravenous (IV) infusion and/or treating with antihistamines and/or acetaminophen as clinically indicated. If an IV infusion of the study intervention is interrupted because of an AE that, in the opinion of the investigator, is not severe or does not result in a serious AE, the infusion may be restarted with caution.^6,7

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 06 December 2024.