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A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial With Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults

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A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial With Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 15 Mar 2023

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At a glance

  • Drugs Fingolimod/tofacitinib (Primary)
  • Indications Atopic dermatitis
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors VYNE Therapeutics

    • Most Recent Events

    • 09 Mar 2023 According to a VYNE Therapeutics media release Based on results and subsequent analysis of this open-label extension portion of this trial, company is evaluating partnering opportunities for this program and intends to focus its resources on the BET inhibitor development programs.
    • 25 Aug 2022 Status changed from active, no longer recruiting to completed.
    • 10 Aug 2022 Primary endpoint has not been met. (Mean Change from Baseline in Atopic Dermatitis Severity Index (ADSI) score at Day 29)

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