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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa

In brief

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.

Key facts

Study ID

NCT04491604

Run by

Krystal Biotech, Inc.

People needed

31

Starts

2020-08-17

Expected to finish

2022-01-14

Last updated by the study team

2023-02-17

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject or legally appointed and authorized representative must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form and must be able to and willing to follow study procedures and instructions.
• Age ≥ 6 months and older at the time of Informed Consent.
• Clinical diagnosis of the Dystrophic Epidermolysis Bullosa.
• Confirmation of DEB diagnosis (either DDEB or RDEB) by genetic testing including COL7A1.
• Two (2) cutaneous wounds meeting the following criteria:
• Location: similar in size, located in similar anatomical regions, and have similar appearance
• Appearance: clean with adequate granulation tissue, excellent vascularization, and do not appear infected.
• Subjects and caregivers who, in the opinion of the Investigator, are able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.
• Male or Female of childbearing potential must use a reliable birth control method throughout the duration of the study and for three (3) months post last dose of B-VEC.
• Negative pregnancy test at Visit 1 (Week 1), if applicable.

You may not qualify if…

• Medical instability limiting ability to travel to the Investigative Center.
• Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures, as determined by the Investigator.
• Current evidence or a history of squamous cell carcinoma in the area that will undergo treatment.
• Subjects actively receiving chemotherapy or immunotherapy at Visit 1 (Week 1).
• Active drug or alcohol addiction as determined by the Investigator.
• Hypersensitivity to local anesthesia (lidocaine/prilocaine cream).
• Participation in an interventional clinical trial within the past three (3) months (not including BVEC administration).
• Receipt of a skin graft in the past three (3) months.
• Pregnant or nursing women.

Where it is running

• Mission Dermatology Center — Rancho Santa Margarita, California, United States
• Stanford University — Stanford, California, United States
• Pediatric Skin Research, LLC — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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