SUMMARY

• Nipocalimab is an investigational, fully human, high-affinity, aglycosylated, effectorless immunoglobulin G1 (IgG1) antineonatal 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 (PBO)-controlled trial (VIVACITY-MG3), 3.1% (3/98) of adult patients receiving nipocalimab reported infection or severe infection requiring requiring invasive treatment. compared to 4.1% (4/98) of patients receiving PBO.¹
• In a phase 2, randomized, double-blind, multicenter, PBO-controlled trial (VIVACITY-MG) in adult patients with gMG, 33.3% (18/54) of patients in the combined nipocalimab group reported infections as a treatment-emergent adverse event (TEAE) compared to 21.4% (3/14) of patients in the PBO group.²
• In an ongoing, phase 2/3, open-label, uncontrolled, clinical trial (Vibrance-mg) 14.3% of adolescent (12 to <18 years) patients receiving nipocalimab reported Coronavirus disease-2019 (COVID-19), bacterial vaginosis or an upper respiratory tract infection.³

CLINICAL DATA

VIVACITY-MG3

Antozzi et al (2025)^1,4 evaluated the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of nipocalimab in adults with gMG in a phase 3, randomized, multicenter, double-blind, PBO-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.
  • 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, PBO-controlled treatment phase, a variable-duration, open-label extension phase, and a safety follow-up at 8 weeks after the last infusion.
  • 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.
• Eligible patients were randomized (1:1) to receive a loading dose of intravenous (IV) nipocalimab 30 mg/kg at week 0, followed by 15 mg/kg every 2 weeks (Q2W) or matching PBO through week 24 in addition to standard of care (SOC) therapy.

Results

• A total of 196 patients (nipocalimab, n=98; PBO, n=98) were included in the full analysis set.¹ 
• For the occurrence of infections in adult patients treated with nipocalimab, see Table: Incidence of Infections.^1,4 
• Through week 24, 3% (3/98) of patients receiving nipocalimab and 4% (4/98) of patients receiving PBO reported severe infection or infection requiring invasive treatment.¹ 

Phase 2 VIVACITY-MG Study

Antozzi et al (2024)² conducted a phase 2, randomized, multicenter, double-blind, PBO-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.
• Eligible patients were randomized (1:1:1:1:1) to receive IV infusions of nipocalimab 5 mg/kg once every 4 weeks (Q4W), nipocalimab 30 mg/kg Q4W, nipocalimab 60 mg/kg single dose, nipocalimab 60 mg/kg Q2W, or PBO Q2W (5% dextrose in water) in addition to SOC therapy.

Results

• A total of 68 patients (nipocalimab, n=54; PBO, n=14) were randomized to receive treatment.
• In the combined nipocalimab group, 33.3% (18/54) of patients reported infections as a TEAE compared to 21.4% (3/14) of patients in the PBO group, with nasopharyngitis being the most common (see Table: Incidence of TEAE-Related Infections and Infestations in the Nipocalimab Versus PBO Group).² 

Phase 2/3 Vibrance-mg Study

Strober et al (2024)³ presented results through the active treatment phase (study day 1 through week 24) in adolescents (aged 12 to <18 years) with gMG who have an insufficient response to ongoing SOC therapy.

Study Design/Methods

• Adolescent patients, all with anti- AChR antibody positive gMG, were included in the analysis.
• The study consists of a screening period of up to 4 weeks, then a 24-week, open-label, active treatment phase where patients will receive nipocalimab 30 mg/kg IV loading dose at week 0, followed by nipocalimab 15 mg/kg Q2W from week 2 to week 22 in addition to SOC therapy.

Results

• A total of 7 adolescents have been included in the study. The average duration of safety follow-up was 18.37 weeks. For the occurrence of infections in adolescents treated with nipocalimab, see Table: Occurrence of Infections in the Safety Analysis Set through Week 24.³ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 28 February 2025.