Clinical Trial

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

Study acronym: IOLITE
Recruiting Phase 3
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Summary
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-09; most recent amendment 2026-03-11.
Trial Details
NCT Number NCT07016750
Lead Sponsor Krystal Biotech, Inc.
Conditions Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
Enrollment 16 participants
Start Date 2025-06-20
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-12