This is a 112-week (approximately two-year) open-label extension study of Beremagene Geperpavec (B-VEC), for participants aged 2 months and older, who have been diagnosed with Dystrophic Epidermolysis Bullosa (DEB). Participants will be dosed weekly with the topical B-VEC therapy. The primary endpoint will be to assess long term safety and tolerability of the topical gene therapy. The study is for those who participated in Phase 3 study, as well as, new participants who were unable to participate in the Phase 3 study, who meet all enrollment criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein
Mission Dermatology Center
Rancho Santa Margarita, California, United States
Stanford University
Redwood City, California, United States
Pediatric Skin Research
Coral Gables, Florida, United States
Northwestern University
Chicago, Illinois, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Ascension Seton- Dell's Children Medical Group
Austin, Texas, United States
To record safety outcomes of participants while on B-VEC.
Record reportable Adverse (AE) and Serious Adverse Events (SAEs) during the continued use of B-VEC to participants who have participated in and completed Krystal Biotech's Phase 3 Protocol (A Phase 3 Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, previously KB103) for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)), as an extension of use, upon study completion; as well as, for participants diagnosed with DEB who have not participated in the B-VEC Phase 3 trial.
Time frame: Up to 112 weeks
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