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IMAAVY™ (nipocalimab-aahu)

Medical Information

IMAAVY - Comparison to Other Neonatal Fragment Crystallizable Receptor Blockers in Patients with Generalized Myasthenia Gravis

Last Updated: 12/11/2025

SUMMARY  

  • The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
  • 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 neonatal fragment crystallizable receptor (FcRn)-targeted therapy. The study will also assess the efficacy and safety of IMAAVY in patients switching from efgartigimod to IMAAVY.1  

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.1

Study Design/Methods


Select Inclusion/Exclusion Criteria in the EPIC Study1
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,1 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 Trial1
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 Design1

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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 10 November 2025. Summarized in this response are relevant data from head-to-head, randomized controlled clinical trials in adult patients with gMG.

References