Pruritus Clinical Trial
Official title:
A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients
Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and safe in treating moderate to severe pruritus in patients with Epidermolysis Bullosa (EB).
Itch is the most common complaint reported by patients with EB of all subtypes, and there is
no current effective treatment. Itch often triggers scratching that creates new wounds and
increases EB disease severity.
This study aims to target the physiological mechanisms of pruritus (itch) in patients with
EB. Substance P is a major mediator of pruritus and binds to the receptor neurokinin-1 (NK1),
which is expressed in the central nervous system and the skin.
VPD-737 (serlopitant), a novel drug that inhibits the NK1 receptor, has been shown to reduce
severe itch in a previous study of 257 adult patients with chronic pruritus.
Each patient will be un-blinded individually after completing 3 months of study period.
All patients who complete the study will be offered a 2-month period on active drug. Patient
who received active drug in the first period will be contacted and asked if they would like
to continue on active drug for an additional 2 months.
Patients who received placebo in the first period will be contacted and asked if they would
like to repeat the study on open label for 2 months.
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