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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 3 study to compare efficacy and safety of masitinib at 6 mgkgday to placebo in treatment of...

The objective is to compare the safety and efficacy of masitinib to placebo in patients with documented Smouldering or Indolent Systemic mastocytosis with severe handicap Primary endpoint: Cumulative response by patienthandicap