At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 31 enrolled
Drug / intervention
Topical Beremagene Geperpavec +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)
In Brief
A Phase 3 clinical trial evaluating Topical Beremagene Geperpavec and Placebo for Dystrophic Epidermolysis Bullosa and 2 related conditions. Completed, enrolled 31 participants across 3 sites.
Detailed Summary
To determine whether administration of topical B-VEC improves wound healing as compared to placebo, and to evaluate durability, repeat dosing (Primary Endpoint) and further obtain safety and tolerability data.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartAug 2020
Primary CompletionOct 2021
Study CompletionJan 2022
TodayJul 2026
First PostedJul 29, 2020
Enrollment StartAug 17, 2020
Primary CompletionOct 29, 2021
Study CompletionJan 14, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.9 years ago
Interventions
Topical Beremagene Geperpavecbiological
Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein
Placeboother
Matching masked inactive topical gel