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A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Study acronym: ARTEMIS
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 17 words Secondary endpoints: details revised at 1 of 1 entry · Site details revised at 3 of 5 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 3 of 5 sites
  2. 4 versions Re-verified since Apr 24, 2026, no change to tracked fieldsv9-v12
  3. Site details revised at 1 of 5 sitesv8
  4. Start date changed from estimate of Feb 15, 2026 to Feb 23, 2026 Site contacts updated at 1 of 5 sitesv7 Show 1 more changeShow less
    • Site contacts updated at 1 of 5 sites
  5. Start date: Jan 5, 2026 to Feb 15, 2026 Site details revised at 1 of 5 sitesv6 Show 1 more changeShow less
    • Site details revised at 1 of 5 sites
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Dec 1, 2025 to Jan 5, 2026v5
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 1, 2025 to Dec 1, 2025 · Site details revised at 5 of 5 sitesv4 Show 2 more changesShow less
    • Start date: Nov 1, 2025 to Dec 1, 2025
    • Site details revised at 5 of 5 sites
  3. Study sites: 4 to 5v3
  4. Start date: Oct 1, 2025 to Nov 1, 2025 Study sites: 3 to 4v2 Show 1 more changeShow less
    • Study sites: 3 to 4
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 1b, Multicenter, Open-Label, Dose Finding Study to Investigate the Safety and Tolerability of a Single Intravenous Dose of SGT-501 in participants with catecholaminergic polymorphic ventricular tachycardia (CPVT). The first-in-human (FIH) safety study will focus on obtaining safety data in adult participants. Cohort 1 and Cohort 2 (optional for dose exploration) will include participants ≥ 18 years of age. Cohort 3 will include participants ≥ 7 to \< 18 years of age and will be initiated following data and safety monitoring board (DSMB) recommendations. Participants will be monitored for 5 years post-administration of SGT-501 including the active treatment period (1 year) and long-term follow-up (LTFU) (4 years) period.
Trial Details
NCT Number NCT07148089
Lead Sponsor Solid Biosciences Inc.
Conditions Catecholaminergic Polymorphic Ventricular Tachycardia
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov