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IMAAVY™

(nipocalimab-aahu)

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IMAAVY™ (nipocalimab-aahu)

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IMAAVY - Overview of the EPIC Clinical Trial

Last Updated: 11/10/2025

SUMMARY

  • The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
  • IMAAVY is a fully human, aglycosylated, effectorless immunoglobulin G1 (IgG1) monoclonal antibody that binds with high affinity to the IgG-binding site on the neonatal Fc receptor (FcRn).1-3
    • By interfering with the binding of IgG to FcRn, IMAAVY increases the lysosomal degradation of IgG, which reduces serum levels of total IgG and pathogenic IgG autoantibodies that cause myasthenia gravis (MG).
  • EPIC (NCT07217587) is an ongoing phase 3b, multicenter, randomized, open-label, active-controlled interventional study with a parallel-group design, including treatment switching in adults with generalized myasthenia gravis (gMG), that will evaluate the efficacy of IMAAVY vs efgartigimod in patients initiating FcRn-targeted therapy. The study will also assess the efficacy and safety of IMAAVY in patients switching from efgartigimod to IMAAVY.4 

CLINICAL DATA

Phase 3 Study: EPIC

An ongoing, open-label, active-controlled, multicenter, randomized phase 3b clinical trial with a parallel-group design, including treatment switching in adults with gMG, that will evaluate the efficacy of IMAAVY vs efgartigimod in patients initiating FcRn-targeted therapy. The study will also assess the efficacy and safety of IMAAVY in patients switching from efgartigimod to IMAAVY.4

Study Design/Methods


Select Inclusion/Exclusion Criteria in the EPIC Study4
Inclusion Criteria
Exclusion Criteria
  • Adults ≥18 and <75 years
  • Diagnosis of gMG MGFA Class II a/b, III a/b, or IV a/b at screening
  • Positive anti-AChR antibody
  • MG-ADL score ≥5 with ≥50% non-ocular

Arms 1 and 2 only
  • Suboptimal response to current stable therapya for gMG (per investigator)
  • Total IgG ≥6 g/L at screening

Arm 3 only
  • Treatment with efgartigimod IV or SC for ≥1 cycle, with the final cycle per local label
  • Patient and HCP agree on switch to IMAAVY
  • Received rituximab within 24 weeks prior to baseline
  • Received plasmapheresis, immunoadsorption therapy, or IVIG within 4 weeks prior to baseline

Arms 1 & 2
  • Prior treatment for MG with an FcRn-targeting therapy
  • Currently taking IgG monoclonal antibody therapeutics or Fc-conjugated therapeutic agents (including factor/enzyme replacement)

Arm 3
  • Currently taking IgG monoclonal antibody therapeutics or Fc-conjugated therapeutic agents (including factor/enzyme replacement), except efgartigimod
Abbreviations: AChE, acetylcholinesterase, anti-AChR, anti-acetylcholine receptor; Fc, fragment crystallizable, FcRn, neonatal Fc receptor; gMG, generalized myasthenia gravis; HCP, healthcare professional; IgG, immunoglobulin G; IV, intravenous; IVIG, intravenous immunoglobulin; MG, Myasthenia Gravis; MG-ADL, Myasthenia Gravis Activities of Daily Living; MGFA, Myasthenia Gravis Foundation of America; SC, subcutaneous.
aStable therapy is defined as: 1) if taking an AChE inhibitor, receiving a stable dose and regimen for ≥2 weeks prior to baseline, 2) if taking a glucocorticosteroid, receiving a stable dose and regimen for ≥3 weeks prior to baseline, or 3) if currently receiving immunosuppressants, receiving the given immunosuppressant for ≥24 weeks and on a stable dose for ≥12 weeks prior to baseline. Allowed concomitant immunosuppressants are azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, cyclosporine, tacrolimus, or cyclophosphamide.
  • The study consists of a screening period of up to 32 days, a 12-week randomized open-label head-to-head phase (Arms 1 and 2) or an up to 12-week run-in phase followed by a 12-week open-label treatment switch phase (Arm 3), and an 8-week safety follow-up phase. For study design/methods,4 see Figure: EPIC Study Design.
  • The primary and key secondary endpoints across EPIC trial are described in Table: Key Endpoints in the EPIC Trial.

Key Endpoints in the EPIC Trial4
Study Phase
Primary Endpoint
Time Frame
Head-to-Head Phase
Averaged mean percent CFB in total IgGa between Arms 1 and 2
Weeks 8 to 12
Study Phase
Key Secondary Endpoints
Time Frame
Head-to-Head Phase
Averaged mean CFB in MG-ADLa and QMGa total score between Arms 1 and 2
Weeks 8 to 12
Mean CFB in MG-ADLa and QMGa total score between Arms 1 and 2
Week 8
Mean percent CFB in total IgGa in Arms 1 and 2
Week 8
Treatment Switch Phase
Mean percent change in total IgG and mean change in MG-ADL total score from pre IMAAVY exposure (SD1) to end of IMAAVY study treatment (SW12/EoT) in Arm 3
EoT
Abbreviations: CFB, change from baseline; EoT, end of treatment; IgG, immunoglobulin G; MG-ADL, Myasthenia Gravis Activities of Daily Living; QMG, Quantitative Myasthenia Gravis; SD1, switch day 1; SW12, switch week 12.
aType I error rate controlled at the 2-sided 0.05 significance level using fixed sequence gatekeeper approach and Hochberg step-up procedure.

EPIC Study Design4

Abbreviations: D, day; IV, intravenous; MG-ADL, Myasthenia Gravis Activities of Daily Living; SC, subcutaneous; SD, switch day; SW, switch week; W, week.

  • Key safety endpoints included the percentage of patients with ≥1 adverse event (AE), serious AE, or AE of special interest (infection, venous thromboembolism, and hypoalbuminemia ≥grade 3) and descriptive analyses of abnormal laboratory tests, vital signs, and physical examination findings.
  • All efficacy and safety analyses will be based on the full analysis sets (FAS):
    • Arms 1 and 2: All randomized participants who received ≥1 dose (partial or complete) of any study intervention
    • Arm 3: All participants who received ≥1 dose (partial or complete) of IMAAVY on or after switch day 1
  • Additional details regarding the EPIC study can be found on clinicaltrials.gov.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 17 October 2025.

 

References

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1 Ramachandren S, Sanga P, Burcklen M, et al. Vivacity MG phase 3 study: clinical trial of nipocalimab administered to adults with generalized myasthenia gravis. Oral Presentation presented at: 8th European Academy of Neurology Congress; June 25-28, 2022; Vienna, Austria.  
2 Antozzi C, Guptill J, Bril V, et al. Safety and efficacy of nipocalimab in patients with generalized myasthenia gravis: results from the randomized phase 2 VIVACITY-MG study. Neurology. 2024;102(2):e207937.  
3 Ramchandren S, Black S, Sun H, et al. Vibrance-mg: clinical trial of nipocalimab in pediatric myasthenia gravis. Poster presented at: 8th European Academy of Neurology Congress; June 25-28, 2022; Vienna, Austria.  
4 Muppidi S, Corse A, Wiendl H, et al. Efficacy and safety of nipocalimab vs efgartigimod in a randomized, open-label, phase 3b, interventional trial including within class switching from efgartigimod to nipocalimab (EPIC): study design. Poster presented at: AANEM Annual Meeting; October 29-November 1, 2025; San Francisco, CA.