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Gene Therapy for ACM Due to a PKP2 Pathogenic Variant

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Feb 2026 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Feb 2027 to Mar 2027
    • Site details revised at 5 of 5 sites
    v13
  2. Site contacts updated at 1 of 5 sitesv12
  3. Study sites: 4 to 5v11
  4. Eligibility criteria revisedv10
  5. Study sites: 3 to 4v9
Show 7 earlier versionsHide 7 earlier versions
  1. Site contacts updated at 1 of 3 sitesv8
  2. Study sites: 2 to 3v7
  3. Study sites: 1 to 2v6
  4. Eligibility criteria expanded, about 52 wordsv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2024 to Feb 29, 2024
    v4
  6. Start date: Dec 2023 to Feb 2024
    • Primary completion date: Dec 2025 to Feb 2026
    • Study completion date: Dec 2026 to Feb 2027
    v3
  7. Primary endpoint revisedv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 1/2, first-in-human, open-label, intravenous, dose-escalating, multicenter trial that is designed to assess the safety and tolerability of LX2020 in adult patients with PKP2-ACM
Trial Details
NCT Number NCT06109181
Lead Sponsor Lexeo Therapeutics
Conditions
(from sponsor)		 Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC
Related terms Arrhythmogenic Right Ventricular Dysplasia, Cardiomyopathies, Death, Sudden, Cardiac, Heart Arrest
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov