A Phase 3 interventional study of KB803 and Placebo in Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Krystal Biotech, Inc.. Recruiting at 5 sites in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Krystal Biotech, Inc. · Phase 3, Interventional, and Treatment
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.
78 studies on the registry are indexed under Epidermolysis Bullosa Dystrophica; 21 are open to participants now.
This study's planned enrollment of 16 is above the median of 9 across 55 interventional studies indexed under Epidermolysis Bullosa Dystrophica.
Browse Epidermolysis Bullosa Dystrophica studies →Krystal Biotech, Inc. is the lead sponsor of 18 studies on the registry; 9 are open to participants now.
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A drug or device being studied in a clinical trial.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KB803
Biological: KB803
Vehicle
Drug: Placebo
Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein
Vehicle
To 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
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
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Epidermolysis Bullosa Dystrophica →
Krystal Biotech, Inc.