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A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis

Study acronym: EMERALD-1
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Enrollment target: 27 to 60v2 Show 9 more changesShow less
    • Primary completion date: Dec 2025 to Dec 2026
    • Primary endpoints: 1 to 2
    • Study sites: 6 to 9
    • Study completion date: Oct 2026 to Dec 2027
    • Start date changed from estimate of May 2025 to Jul 7, 2025
    • Eligibility criteria shortened, about 23 words
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 1 word
    • Study title expanded, about 1 word
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.
Trial Details
NCT Number NCT06999733
Lead Sponsor Krystal Biotech, Inc.
Conditions
(from sponsor)		 Neurotrophic Keratitis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov