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 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 wounds in approximately 20 RDEB 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). Up to three target wound pairs will be identified for each subject. FCX-007 will be administered to one, two or three treatment wounds, as applicable; the corresponding paired control wounds will not be treated. Subjects who receive at least one FCX-007 administration will participate in a separate 15-year long-term safety follow-up study.

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

Get more information on ClinicalTrials.gov