IMAAVY™

(nipocalimab-aahu)

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IMAAVY™ (nipocalimab-aahu)

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IMAAVY - Overview of the EPIC Clinical Trial

Last Updated: 04/27/2026

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 (Ig)G1 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 lysosomal degradation of IgG, which reduces serum levels of the total IgG and pathogenic IgG autoantibodies that cause myasthenia gravis.
EPIC (NCT07217587) is an ongoing, phase 3b, multicenter, randomized, open-label, active-controlled, interventional study with a parallel-group design (including treatment switching) that is evaluating the efficacy of IMAAVY vs efgartigimod in adult patients with generalized myasthenia gravis (gMG) initiated on FcRn-targeted therapy. The study will also assess the efficacy and safety of IMAAVY in patients who switched from efgartigimod to IMAAVY.⁴

CLINICAL DATA

Phase 3 Study: EPIC

This is an ongoing, open-label, active-controlled, multicenter, randomized, phase 3b, interventional clinical trial with a parallel-group design (including treatment switching) that is evaluating the efficacy of IMAAVY vs efgartigimod in adult patients with gMG initiated on FcRn-targeted therapy. The study will also assess the efficacy and safety of IMAAVY in patients who switched from efgartigimod to IMAAVY.⁴

Study Design/Methods

The key inclusion and exclusion criteria are described in Table: Select Inclusion/Exclusion Criteria in the EPIC Study.

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 Anti-AChR antibody positivity MG-ADL score ≥5, with ≥50% nonocular Arms 1 and 2 only Suboptimal response to current stable therapy^a 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 and 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 follows: 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.

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
Anti-AChR antibody positivity
MG-ADL score ≥5, with ≥50% nonocular

Arms 1 and 2 only

Suboptimal response to current stable therapy^a 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 and 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 follows: 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 followed by a 12-week, randomized, open-label, head-to-head phase (arms 1 and 2) or a run-in phase of up to 12 weeks; a 12-week, open-label treatment switch phase (arm 3); and an 8-week safety follow-up phase. For study design/methods,⁵ see Figure: EPIC Study Design.

EPIC Study Design⁵

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

The primary and key secondary endpoints across the EPIC study are described in Table: Key Endpoints in the EPIC Study.

Key Endpoints in the EPIC Study⁴^,⁵

Study Phase	Primary Endpoint	Time Frame
Head-to-head phase	Averaged mean percent CFB in total IgG^a in arm 1 vs 2	Weeks 8 to 12
Study Phase	Key Secondary Endpoints	Time Frame
Head-to-head phase	Averaged mean CFB in MG-ADL^a and QMG^a total scores in arm 1 vs 2	Weeks 8 to 12
	Mean CFB in MG-ADL^a and QMG^a total scores in arm 1 vs 2	Week 8
	Mean percent CFB in total IgG^a in arms 1 and 2	Week 8
	Mean CFB in MG-ADL total score, QMG total score, and total IgG between Arm 1 at EoT and Arm 2 at EoC based on clinical evaluation^b	EoT (arm 1) EoC (arm 2)
Treatment switch phase	Mean percent change in total IgG and mean change in MG-ADL total score from before IMAAVY exposure (SD1) to end of IMAAVY study treatment (SW12/EoT) in arm 3	EoT
Abbreviations: CFB, change from baseline; EoC, end of cycle; EoT, end of treatment; IgG, immunoglobulin G; MG, myasthenia gravis; 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 a fixed sequence gatekeeper approach and the Hochberg step-up procedure. ^bEoC based on clinical evaluation is defined as the timepoint after the fourth dose of efgartigimod when, based on MG-ADL score clinical criteria, the treatment decision would be made to start a second cycle of efgartigimod, an MG rescue medication, or week 12/EoT, whichever occurs first

Key safety endpoints include 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 test findings, vital signs, and physical examination findings.
All efficacy and safety analyses will be based on full analysis sets:
- 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 05 March 2026.

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.
5	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: Muscular Dystrophy Association (MDA) Clinical and Scientific Conference; March 8–11, 2026; Orlando, FL, USA.