Clinical Studies

Bullosa (EB)

SD-101: Phase 3 Study SD-005

Study of Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa

Active, not recruiting.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of SD-101 Cream in patients 1 month and older with a diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB who have a wound that meets specific study criteria as assessed by a healthcare professional. SD-101 (6%) or placebo will be applied topically, once a day to the entire body for a period of 90 days. Patients who complete the study will be eligible to enroll in an open-label extension Study (SD-006).

More information: NCT02384460

SD-101: Open-Label Extension Study SD-004

Open Label Extension Study to Evaluate the Safety of SD-101 Cream in Subjects with Epidermolysis Bullosa

Ongoing, recruitment closed. Patients who completed the treatment period in the Phase 2b study (SD-003) of SD-101 were eligible to roll over into SD-004.

Open-label extension study to assess the continued safety of topically applied SD-101 Cream (6%) in subjects with Simplex, Recessive Dystrophic, and Junctional non-Herlitz EB. SD-101 (6%) is applied topically, once a day to the entire body.

More information: NCT02090283