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Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa

Study acronym: GOTAS-ELK-EB
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 31, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Dec 2025 to Jun 2026
    • Site details revised
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study consists of two phases: an Observational Phase to evaluate the natural history of ocular manifestations in subjects with Dystrophic and Junctional Epidermolysis Bullosa, followed by a Treatment Phase to assess the effects of ELK-003 eye drops. Each subject will serve as their own control by comparing ocular manifestations documented during the Observational Phase to those recorded during the Treatment Phase.
Trial Details
NCT Number NCT06713434
Lead Sponsor Fundación DEBRA Chile, Niños Piel de Cristal
Collaborators: Eliksa Therapeutics, Inc., Centro de la Vision
Conditions
(from sponsor)		 Junctional Epidermolysis Bullosa, Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
Related terms Corneal Injuries, Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov