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A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa

Study acronym: IOLITE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment target: 20 to 16
    • Site details revised at 2 of 5 sites
    v4
  2. Primary and study completion dates: Mar 2026 to Dec 2026v3 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 16 to 20
    • Study sites: 4 to 5
    • Secondary endpoint revised
    • Study description expanded, about 16 words
    • Study title shortened, about 7 words
  3. Primary endpoints revised (2)v2 Show 6 more changesShow less
    • Start date changed from estimate of Jun 2025 to Jun 20, 2025
    • Interventions: Ophthalmic Beremagene Geperpavec (B-VEC) (Biological), Placebo (Drug) to KB803 (Biological), Placebo (Drug)
    • Eligibility criteria revised
    • Secondary endpoint revised
    • Study description revised
    • Study title revised
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
KB803-EYE-01 is a Phase 3 double-blind, randomized, placebo-controlled, crossover study to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).
Trial Details
NCT Number NCT07016750
Lead Sponsor Krystal Biotech, Inc.
Conditions
(from sponsor)		 Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
Related terms Corneal Injuries, Epidermolysis Bullosa Dystrophica
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov