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A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients — GEM-1  

Dystrophic Epidermolysis Bullosa Clinical Trial

Official title:
A Phase I/II Study of KB103, a Non-Integrating, Replication-Incompetent HSV Vector Expressing the Human Collagen VII Protein, for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

Clinical Trial Summary

This study was conducted to assess the safety and efficacy of topical Beremagene Geperpavec (KB103, HSV1-COL7) on DEB patients.

Clinical Trial Description

The primary objectives were the evaluation of safety, through incidence of adverse events associated with the administration of B-VEC as compared to placebo, as well as the demonstration of molecular correction of the disease by establishing the presence of functional COL7 expression and anchoring fibrils (AF) formation post administration of B-VEC. Additional primary objectives were to assess the proportion of wounds with complete wound closure (≥90% reduction from baseline wound surface area) at Week 8, 10, and 12, the duration of wound closure, and the time to wound closure of B-VEC treated wounds as compared with placebo treated wounds. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03536143
Study type Interventional
Source Krystal Biotech, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 6, 2018
Completion date November 1, 2019
View Details
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