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RecruitingPhase 3NCT07016750

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

A Double-Blind Crossover of KB803 and Matched Placebo for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa

Sponsor

Krystal Biotech, Inc.

Enrollment

16 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Recessive dystrophic epidermolysis bullosaDystrophic Epidermolysis BullosaDEB - Dystrophic Epidermolysis BullosaDominant Dystrophic Epidermolysis Bullosa

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).

Eligibility

Min Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called KB803 and a drug called Placebo for people with deb - dystrophic epidermolysis bullosa, dominant dystrophic epidermolysis bullosa, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 6 Months and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALKB803

Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein

DRUGPlacebo

Vehicle

Locations(5)

Mission Dermatology Center

Rancho Santa Margarita, California, United States

Skin Research Institute

Coral Gables, Florida, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

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NCT07016750

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