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A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 27, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Mar 31, 2025 to Sep 30, 2025v6 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2025 to Sep 30, 2025
    • Eligibility criteria expanded, about 36 words
    • Study description revised
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 5 words
  2. Primary completion date: Aug 1, 2024 to Mar 31, 2025v5 Show 4 more changesShow less
    • Primary endpoints revised (5)
    • Study completion date: Dec 1, 2024 to Jun 30, 2025
    • Study description expanded, about 19 words
    • Eligibility criteria expanded, about 3 words
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v4
  4. Primary endpoints revised (5)
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Mar 24, 2023 to Apr 2, 2023
    v3
  5. Site contacts updated at 1 of 2 sitesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To evaluate and further characterize the safety of EB-101 (LZRSE-Col7A1 gene-corrected keratinocyte sheets with type VII collagen \[C7\] expression) for the treatment of large, chronic DEB wounds in new and previously EB-101 treated patients 12 months and older.
Trial Details
NCT Number NCT05725018
Lead Sponsor Abeona Therapeutics, Inc
Conditions
(from sponsor)		 Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, RDEB
Related terms Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov