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

RELEVANT INCLUSION/EXCLUSION CRITERIA FROM CLINICAL TRIALS

VIVACITY-MG3 Study

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

• Patients with a history of severe and/or uncontrolled hepatic disorder (i.e., viral/alcoholic/autoimmune hepatitis/ cirrhosis and/or metabolic liver disease) or with clinically significant abnormalities in screening laboratory results that could interfere with study participation and/or jeopardize patient safety or the validity of study results were excluded from the trial.⁴ 

Vibrance-mg Study

Ramchandren et al (2022)^5,6  is evaluating the safety, efficacy, PK, and PD of nipocalimab in children and adolescents ages 2 to <18 years with gMG who have an insufficient response to ongoing, stable SOC therapy in an ongoing, open-label, uncontrolled multicenter clinical trial.

• Patients with a history of severe and/or uncontrolled hepatic disorder (i.e., viral/alcoholic/autoimmune hepatitis/ cirrhosis and/or metabolic liver disease) or with clinically significant abnormalities in screening laboratory results that could interfere with study participation and/or might jeopardize patient safety or the validity of study results will be excluded from the trial.⁵

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 08 November 2024.