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
• In a 24-week, phase 3, randomized, double-blind, placebo-controlled trial in adult patients with gMG, peripheral edema was reported as a treatment-emergent adverse event (TEAE) in 11% (11/98) of patients in the nipocalimab group and no cases were reported in the placebo group.³
  • Adverse events of peripheral edema were not considered serious, severe, or led to study discontinuation.
• In a phase 2, randomized, double-blind, placebo-controlled trial in adult patients with gMG, peripheral edema was reported as a TEAE in 1 patient in the nipocalimab 60 mg/kg single dose group and in 2 patients in the nipocalimab 60 mg/kg every 2 weeks (Q2W) group through day 113.^1,4 There were no reports of peripheral edema in the nipocalimab 5 mg/kg every 4 weeks (Q4W), nipocalimab 30 mg/kg Q4W, or placebo groups.

CLINICAL DATA

VIVACITY-MG3

Antozzi et al (2025)³ evaluated the efficacy and safety of nipocalimab in adults with gMG in a phase 3, randomized, multicenter, double-blind, placebo-controlled study.

Study Design/Methods

• Patients (≥18 years of age) with anti- acetylcholine receptor (AChR), muscle-specific tyrosine kinase (MuSK) or low-density lipoprotein receptor 4 (LRP4) antibody positive or seronegative (in all countries except France) gMG (Myasthenia Gravis Foundation of America [MGFA] Class IIa–IVb) were included in the study.^3,5 
  • The safety analysis population included all randomized patients who received ≥1 dose (partial or complete) of any study treatment in the double-blind phase.
• The study consisted of a ≤4-week screening phase, followed by a 24-week, double-blind, placebo-controlled treatment phase, a variable-duration, open-label extension phase, and a safety follow-up at 8 weeks after the last infusion.^3,6 
  • Patients who withdrew or discontinued after receiving any amount of the study intervention were required to complete a safety follow-up assessment at 8 weeks after the last dose.⁵ 
• Eligible patients were randomized (1:1) to receive a loading dose of intravenous nipocalimab 30 mg/kg at week 0 followed by 15 mg/kg every 2 weeks (Q2W) or matching placebo through week 24 in addition to standard of care (SOC) therapy.³ 

Results

• A total of 196 patients (nipocalimab, n=98; placebo, n=98) were included in the safety analysis set.
• Peripheral edema was reported as a TEAE in 11% (11/98) of patients in the nipocalimab group and no cases were reported in the placebo group. 
  • Adverse events of peripheral edema were not considered serious, severe, or led to study discontinuation.

Phase 2 VIVACITY-MG Study

Antozzi et al (2024)¹ conducted a phase 2, randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy, PK, and PD of nipocalimab in adult patients with gMG who had an insufficient response to ongoing, stable SOC therapy.

Study Design/Methods

• Patients (≥18 years of age) with anti-AChR or anti-MuSK antibody positive gMG (MGFA Class II, III, or IVa) were included in the study.
• The study included a 4-week screening period, followed by an 8-week double-blind treatment period. Posttreatment follow-up assessment was performed for a period of 8 weeks.
• In addition to SOC therapy, eligible patients were randomized (1:1:1:1:1) to receive intravenous infusions of nipocalimab 5 mg/kg once Q4W, 30 mg/kg Q4W, 60 mg/kg single dose, or 60 mg/kg Q2W or placebo Q2W (5% dextrose in water).

Results

• A total of 68 patients (nipocalimab, n=54; placebo, n=14) were randomized to treatment.
• Through day 113, peripheral edema was reported as a TEAE in 7.7% (1/13) of patients in the nipocalimab 60 mg/kg single dose group and in 14.3% (2/14) of patients in the nipocalimab 60 mg/kg Q2W group.^1,4 
  • There were no reports of peripheral edema in the nipocalimab 5 mg/kg Q4W (n=14), nipocalimab 30 mg/kg Q4W (n=13) or placebo (n=14) groups.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 30 January 2025.