Date Updated
EB Type
Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Name of Company
Castle Creek Biosciences
Recruitment Status
Recruiting
About the Study

The purpose of this study is to determine whether administration of FCX-007 (also known as D-Fi) in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa.

DEFI-RDEB is a multi-center, intra-patient randomized, controlled, open-label, Phase 3 study of FCX-007 for the treatment of persistent non-healing and recurrent RDEB wounds in approximately 24 subjects. Each subject will serve as his/her own control. Each subject's target wounds will be paired then randomized to receive FCX-007 (treatment wound) or remain untreated (control wound). FCX-007 will be administered to up to three treatment wounds at Day 1 and at Week 12, with additional treatment sessions at Week 24 and Week 36 for remaining treatment or control wounds. Subjects who receive at least one injection of FCX-007 will participate in a 15-year long-term follow-up study.

Trial Entry Criteria
  • Male or female 2 years of age or older.
  • Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.
  • At least two eligible persistent non-healing or recurrent wound sites identified.
  • Please click the link below for exclusion criteria.

Get more information on ClinicalTrials.gov

Get more information on DeFi-RDEB.com