drugset / Trial / NCT07482787
Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | allantoin | Small molecule | 6 % | Topical |