A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
Start Date
6/20/2025
Completion Date
12/1/2026
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).
Detailed Description
Subjects participating in the Sponsor's natural history study (protocol NHS) for at least 12 weeks and that meet all other eligibility criteria will be randomized 1:1 to receive ophthalmic administration of B-VEC three times a week or placebo three times a week for the first 12 week intervention period. During the second 12-week intervention period subjects will be crossed-over to receive the alternative Investigational Product (IP) for an additional 12 weeks. IP will be administered in the home setting by a trained designee. The Investigator (or designee) will contact subjects (or their parent/legal guardian) to assess for any adverse events or changes in medications, treatments, or procedures. Subjects (or their parent/legal guardian) will complete weekly symptom diaries and monthly questionnaires to document corneal abrasion symptoms and frequency and gauge overall subject (or parent/legal guardian) impressions of disease severity and disease/symptom changes during the study.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
KB803
Placebo
Conditions
Locations
Mission Dermatology Center
Rancho Santa Margarita, California 92688
United States
Skin Research Institute
Coral Gables, Florida 33146
United States
UMass Memorial Medical Center
Worcester, Massachusetts 01605
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United States