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A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 With a Parallel Optional Maximal Use Arm- in Treatment of RXLI or ARCI Ichthyosis in Subjects Aged >6

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A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 With a Parallel Optional Maximal Use Arm- in Treatment of RXLI or ARCI Ichthyosis in Subjects Aged >6

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2024

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At a glance

  • Drugs Isotretinoin (Primary) ; Isotretinoin (Primary)
  • Indications Congenital ichthyosiform erythroderma
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCEND
  • Sponsors LEO Pharma; Trex Wind-down

    • Most Recent Events

    • 21 Aug 2024 Primary endpoint (Change in Investigator global assessment (IGA) score) has not been met, according to a LEO Pharma Media Release.
    • 21 Aug 2024 According to a LEO Pharma Media Release, trial results do not support submission of a New Drug Application to the US FDA.
    • 21 Aug 2024 According to a LEO Pharma Media Release, detailed results are planned to be submitted for scientific publication at a later date.

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