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
Latest Information Update: 21 Jan 2024
At a glance
- Drugs Masitinib (Primary)
- Indications Mastocytosis; Systemic mastocytosis
- Focus Registrational; Therapeutic Use
- Sponsors AB Science
- 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.