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A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicap

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Trial Profile

A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicap

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2024

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At a glance

  • Drugs Masitinib (Primary)
  • Indications Mastocytosis; Systemic mastocytosis
  • Focus Registrational; Therapeutic Use
  • Sponsors AB Science

    • Most Recent Events

    • 15 Jan 2024 According to an AB Science media release, the company announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis with masitinib, based on findings from this study.
    • 04 Nov 2019 According to an AB Science media release, the company will provide an overview of this trial results in a webcast which will feature a presentation by key opinion leaders on 20th Nov 2019.
    • 05 Jun 2019 This trial has been completed in Latvia, Austria, Bulgarian, Spain, Italy,Hungary according to European Clinical Trials Database.
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