Clinical trial
Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
NCT04491604 · Krystal Biotech, Inc., Industry · Completed
Key facts
| NCT number | NCT04491604 |
|---|---|
| Title | Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB |
| Official title | A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) |
| Acronym | GEM-3 |
| Lead sponsor | Krystal Biotech, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa |
| Intervention type | Biological, Other |
| Interventions | Topical Beremagene Geperpavec, Placebo |
| Enrollment | 31 |
| Start date | Aug 17, 2020 |
| Primary completion | Oct 29, 2021 |
| Completion | Jan 14, 2022 |
| First posted | Jul 29, 2020 |
| Last update posted | Feb 17, 2023 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: