CompletedPhase 1/2

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

United States12 participantsStarted 2018-05-06

Plain-language summary

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

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Phase 1: 18 years old or older,
. Phase 2a: 5 years old or older,
. Phase 2b: 2 years old or older,
. Phase 2c: 2 years old or older.
. Phase 1: Two wounds up to 10 cm2; 1 randomized to B-VEC and 1 randomized to placebo
. Phase 2a and 2b: At least 3 wounds up to 20 cm2; 2 wounds randomized to B-VEC and 1 randomized to placebo
. Phase 2c: At least 2 wounds up to 50 cm2; at least 1 randomized to B-VEC and 1 randomized to placebo

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects Reported at Least One Adverse Event, Safety Population

Timeframe: baseline to 12 weeks

Number of Adverse Events Reported, Safety Population

Timeframe: baseline to 12 weeks

Complete Wound Closure Responder, ITT Population

Timeframe: from baseline at Weeks 8, 10, and 12

Time to Wound Closure Analysis, ITT Population

Timeframe: baseline to complete wound closure

Duration of Wound Closure, ITT Population

Timeframe: Time from the complete closure to the first reopening of the same wound

Trial details

NCT IDNCT03536143

SponsorKrystal Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-01

Results submitted2022-08-18

View on ClinicalTrials.gov More Dystrophic Epidermolysis Bullosa trials

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Phase 1: 18 years old or older,
. Phase 2a: 5 years old or older,
. Phase 2b: 2 years old or older,
. Phase 2c: 2 years old or older.
. Phase 1: Two wounds up to 10 cm2; 1 randomized to B-VEC and 1 randomized to placebo
. Phase 2a and 2b: At least 3 wounds up to 20 cm2; 2 wounds randomized to B-VEC and 1 randomized to placebo
. Phase 2c: At least 2 wounds up to 50 cm2; at least 1 randomized to B-VEC and 1 randomized to placebo

What they're measuring

Number of Subjects Reported at Least One Adverse Event, Safety Population

Timeframe: baseline to 12 weeks

Number of Adverse Events Reported, Safety Population

Timeframe: baseline to 12 weeks

Complete Wound Closure Responder, ITT Population

Timeframe: from baseline at Weeks 8, 10, and 12

Time to Wound Closure Analysis, ITT Population

Timeframe: baseline to complete wound closure

Duration of Wound Closure, ITT Population

Timeframe: Time from the complete closure to the first reopening of the same wound