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.
- 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.