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

NCT03536143 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-31

Study results available
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Summary

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

Conditions

  • Dystrophic Epidermolysis Bullosa

Interventions

BIOLOGICAL

Topical beremagene geperpavec

Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein

BIOLOGICAL

Placebo gel

Placebo gel

Sponsors & Collaborators

  • Krystal Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-06
Primary Completion
2019-11-01
Completion
2019-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03536143 on ClinicalTrials.gov