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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Aug 2024

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At a glance

  • Drugs Nemolizumab (Primary)
  • Indications Prurigo nodularis
  • Focus Registrational; Therapeutic Use
  • Acronyms OLYMPIA 2
  • Sponsors Galderma; Galderma Research & Development

    • Most Recent Events

    • 13 Aug 2024 According to Galderma media release, based on result form phase III OLYMPIA 1 and OLYMPIA 2 clinical trials, the U.S. Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.
    • 07 May 2024 According to Galderma media release, The FDA subsequently granted nemolizumab 'Priority Review' for the treatment of prurigo nodularis; its decisions on prurigo nodularis and atopic dermatitis are anticipated in 2024.
    • 07 May 2024 According to Galderma media release, the company has received the FDA and European Medicines Agency (EMA) acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis (AD) in Australia, Singapore, Switzerland, and the United Kingdom. Further submissions to regulatory authorities in additional countries are ongoing.

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