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A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase 3 study to compare efficacy and safety of masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment

Trial Profile

A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase 3 study to compare efficacy and safety of masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2024

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At a glance

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

Most Recent Events

  • 15 Feb 2024 This trial has been completed in Lithuania, according to the European Clinical Trials Database record.
  • 31 Jul 2023 This trial has been suspended in Netherlands, according to the European Clinical Trials Database record.
  • 03 May 2023 Planned End Date changed from 1 Dec 2022 to 1 Jun 2025.

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