NCT07482813

An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

An Open Label Extension, Multi-Center Study to Evaluate the Safety of SD 101 Cream in Subjects With Epidermolysis Bullosa

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Paradigm Therapeutics · Industry
• Sex: All
• Age: 28 Days – 12 Years
• Healthy volunteers: Not accepted

Summary

The objective is to characterize the continued safety of SD-101 cream containing 6% allantoin in the treatment of the skin in patients with Simplex, Recessive Dystrophic, or JEB-nH EB.

Detailed description

This is an open label extension, multi-center, study to assess the continued safety of topically applied SD-101 cream containing (6% allantoin) across the entire skin surface in subjects with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB. SD-101 cream (containing 6% allantoin) will be applied topically, once a day to the entire body for a period of up to 1 year or until approval. Subjects who complete the SD-007 study will roll over into the SD-008 open label extension study. The baseline visit 1 for SD-008 will occur at the time of the final visit for SD-007. The safety evaluation from the SD-007 final visit will provide the baseline safety assessment for the SD-008 study.

Conditions

• Epidermolysis Bullosa (EB)

Interventions

Type	Name	Description
DRUG	SD-101 Dermal Cream (6%)	SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.

Timeline

• Start date: 2026-07-15
• Primary completion: 2027-07-19
• Completion: 2027-08-19
• First posted: 2026-03-19
• Last updated: 2026-03-19

Regulatory

• FDA-regulated drug study