Clinical Trial

Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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).
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-24
Trial Details
NCT Number NCT07482787
Lead Sponsor Paradigm Therapeutics
Conditions Epidermolysis Bullosa (EB)
Enrollment 80 participants
Start Date 2026-07-21
Primary Completion 2027-05-17 (estimated)
Study Completion 2027-06-17 (estimated)
Updated on ClinicalTrials.gov 2026-08-13