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A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Feb 2019

At a glance

  • Drugs Tradipitant (Primary)
  • Indications Atopic dermatitis; Pruritus
  • Focus Registrational; Therapeutic Use
  • Acronyms EPIONE
  • Sponsors Vanda Pharmaceuticals
  • Most Recent Events

    • 13 Feb 2019 According to a Vanda Pharmaceuticals media release, results from this study is expected in the first half of 2020.
    • 05 Feb 2019 According to a Vanda Pharmaceuticals media release and the Investigator's Email, the company has filed a complaint against the US FDA, requesting court to lift the partial clinical hold, preventing Vanda from continuing the studies of Tradipitant in humans for longer than 12-weeks (Comment:"The partial clinical hold prevents Vanda from continuing to study tradipitant in humans for longer than 12-weeks duration, Vanda continues to work through the FDA development process for tradipitant")
    • 02 Jul 2018 New trial record
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