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Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB

NCT04491604 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-02-17

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Krystal Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2021-10-29
Completion
2022-01-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491604 on ClinicalTrials.gov