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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Mission Dermatology Center
Rancho Santa Margarita, California, United States
RECRUITINGSkin Research Institute
Coral Gables, Florida, United States
RECRUITINGUMass Memorial Medical Center
Worcester, Massachusetts, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGTexas Dermatology and Laser Specialists
San Antonio, Texas, United States
RECRUITINGTo evaluate the safety and tolerability of KB803.
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
Time frame: 24 weeks
To evaluate the effect of ophthalmic KB803 on frequency of corneal abrasion symptoms.
Average number of days per month with corneal abrasion symptoms.
Time frame: 24 weeks
To evaluate the effect of ophthalmic KB803 on eye pain.
Average weekly eye pain score. Pain will be measured using a numerical scale with 0 being no hurt through 10 being the worst hurt.
Time frame: 24 weeks
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