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Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Study acronym: EPIC
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Study sites: 17 to 19 · Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 17 of 20 entries Show 3 more changesShow less
    • Study sites: 17 to 19
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 17 of 20 entries
  2. Site details revised at 1 of 17 sitesv11
  3. Study sites: 15 to 17v10
  4. Completion moved earlier from Jul 31, 2029 to Jan 29, 2029 Study sites: 14 to 15v9 Show 1 more changeShow less
    • Study sites: 14 to 15
  5. Completion pushed from Dec 11, 2028 to Jul 31, 2029 Study sites: 12 to 14v8 Show 1 more changeShow less
    • Study sites: 12 to 14
  6. Trial sites expanded: 8 → 12 locationsv7
  7. Study sites: 7 to 8v6
  8. Study sites: 5 to 7v5
  9. Completion date: Sep 4, 2028 to Dec 11, 2028v4
  10. Study sites: 2 to 5 Start date changed from estimate of Nov 28, 2025 to Jan 5, 2026 · Eligibility criteria revised · Secondary endpoints: 17 to 20v3 Show 3 more changesShow less
    • Start date changed from estimate of Nov 28, 2025 to Jan 5, 2026
    • Eligibility criteria revised
    • Secondary endpoints: 17 to 20

    See this version in full on ClinicalTrials.gov ↗

  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  12. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
Trial Details
NCT Number NCT07217587
Lead Sponsor Janssen Research & Development, LLC
Conditions Myasthenia Gravis
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov