drugset

drugset / Trial / NCT03536143

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

NCT03536143 ↗

Phase 1/2 Completed 12 enrolled Krystal Biotech, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2018-05-06
Primary completion: 2019-11-01
Completion: 2019-11-01

Outcome

Met primary endpoint

registry analysis (superiority test); Topical Beremagene Geperpavec vs Placebo; p = 0.0216; Log Rank NCT03536143 ↗

registry analysis (superiority test); Topical Beremagene Geperpavec vs Placebo; p = 0.0009; Log Rank NCT03536143 ↗

Publications

Results Gurevich I, Agarwal P, Zhang P, Dolorito JA, Oliver S, Liu H, Reitze N, Sarma N, Bagci IS, Sridhar K, Kakarla V, Yenamandra VK, O'Malley M, Prisco M, Tufa SF, Keene DR, South AP, Krishnan SM, Marinkovich MP. In vivo topical gene therapy for recessive dystrophic epidermolysis bullosa: a phase 1 and 2 trial. Nat Med. 2022 Apr;28(4):780-788. doi: 10.1038/s41591-022-01737-y. Epub 2022 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Beremagene Geperpavec	Unknown	—	Topical

Indications