A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa
The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry. There are only 4 site visits by patients with minimal assessments over a 2-month period, and patients completing this study will have the ability to continue receiving SD-101-6.0 at home in an open-label extension study. The drug product and placebo require no special preparation or storage conditions (room temperature).
• Informed Consent (ICF) form signed by the patient or patient's legal representative. Since all patients with be 12 years old or younger at study entry, signed assent from the patient's legal representative will be required.
• Patient (or caretaker) must be willing to comply with all protocol requirements.
• Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH (intermediate) EB.
• Patient must have 1 target wound (size 10 to 50 cm2).
• Patients must be between 28 days to 12 years at study entry
• Target wound must be present for 21 days or more.
• Patients must have wound burden based on BSA of ≥5% at baseline