Trials / Completed
CompletedNCT04491604
Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Krystal Biotech, Inc. · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
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.
Detailed description
Thirty-one (31) participants with DEB, aged 6 months or older at time of consent were enrolled for this Phase III study. The trial duration for each subject was about 6 months, with administration occurring once weekly. A Safety Follow-up Visit occurring 30 days from the date of final treatment with the Investigational Product also occurred. Each subject provided one pair of primary target wounds, with one wound from each pair randomized to be treated with B-VEC and the other wound with placebo. In addition to the primary target wound pair(s), additional wounds (secondary wounds) were selected to be treated with B-VEC. Throughout the study, participants complete questionnaires, had images captured of their study wounds, underwent physical exams, had vital signs and safety labs monitored.
Conditions
- Dystrophic Epidermolysis Bullosa
- Recessive Dystrophic Epidermolysis Bullosa
- Dominant Dystrophic Epidermolysis Bullosa
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Topical Beremagene Geperpavec | Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein |
| OTHER | Placebo | Matching masked inactive topical gel |
Timeline
- Start date
- 2020-08-17
- Primary completion
- 2021-10-29
- Completion
- 2022-01-14
- First posted
- 2020-07-29
- Last updated
- 2023-02-17
- Results posted
- 2023-02-17
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04491604. Inclusion in this directory is not an endorsement.