drugset / Trial / NCT07482787

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

NCT07482787

Phase 3 Not yet recruiting 80 enrolled Paradigm Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2026-05-15
Primary completion
2027-05-17
Completion
2027-06-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator allantoin Small molecule 6 % Topical

Indications