Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
Trial ID or NCT#
NCT04491604
Status
RECRUITING
Purpose
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.
Official Title
A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)
Eligibility Criteria
Ages Eligible for Study: Older than 6 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. 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. 2. Age ≥ 6 months and older at the time of Informed Consent. 3. Clinical diagnosis of the Dystrophic Epidermolysis Bullosa. 4. Confirmation of DEB diagnosis (either DDEB or RDEB) by genetic testing including COL7A1. 5. Two (2) cutaneous wounds meeting the following criteria: 1. Location: similar in size, located in similar anatomical regions, and have similar appearance 2. Appearance: clean with adequate granulation tissue, excellent vascularization, and do not appear infected. 6. 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. 7. 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. 8. Negative pregnancy test at Visit 1 (Week 1), if applicable.
Exclusion Criteria:
- 1. Medical instability limiting ability to travel to the Investigative Center. 2. 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. 3. Current evidence or a history of squamous cell carcinoma in the area that will undergo treatment. 4. Subjects actively receiving chemotherapy or immunotherapy at Visit 1 (Week 1). 5. Active drug or alcohol addiction as determined by the Investigator. 6. Hypersensitivity to local anesthesia (lidocaine/prilocaine cream). 7. Participation in an interventional clinical trial within the past three (3) months (not including BVEC administration). 8. Receipt of a skin graft in the past three (3) months. 9. Pregnant or nursing women.
Investigator(s)
M. Peter Marinkovich, MD
Dermatologist,
Blistering disease specialist,
Psoriasis specialist
Associate Professor of Dermatology
Contact us to find out if this trial is right for you.
Contact
Sinem Bagci, MD
650-484-6878
View on ClinicalTrials.gov
