Amicus Therapeutics’ Phase 3 EB Clinical Trial
Below you will find updated information about the ESSENCE Study, a Phase 3 clinical trial of SD-101, an investigational topical cream being developed by Amicus, together with Scioderm, to treat skin blistering and lesions associated with Epidermolysis Bullosa (EB).
What is the ESSENCE Phase 3 Study?
The ESSENCE Study is currently underway in the U.S. and Europe, with sites planned in additional geographies.
The double-blind, placebo-controlled trial will evaluate the safety and efficacy of SD-101 in patients with various subtypes of EB (Simplex, Recessive Dystrophic and Junctional [non-Herlitz]).
Participants will be randomized 1:1 to two treatment groups receiving either SD-101 6% or placebo applied over their entire body once daily for three months.
The primary efficacy endpoint will be complete closure of a target wound. Improvement in itching, pain, and full-body wound and lesion coverage will also be assessed. Investigators will also assess safety.
It is expected that everyone completing the three-month study will be offered the option to receive active SD-101 in an open-label extension trial.
Trial Entry Criteria
Consult with a healthcare professional to see if you meet the entry criteria.
- Participants must be at least one month of age and older
- Participants must have a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB
- Participants must have a wound that meets specific study criteria as assessed by a healthcare professional
For further information about the ESSENCE Study, SD-101, or to participate in the study, click here.
For more information, email info [at] ebstudy [dot] com