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.

Age range2 Years

SexALL

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✓. 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

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

NCT IDNCT03536143

SponsorKrystal Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-01

Results submitted2022-08-18