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A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy

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Trial Profile

A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Oct 2025

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At a glance

  • Drugs Avapritinib (Primary)
  • Indications Systemic mastocytosis
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms PIONEER
  • Sponsors Blueprint Medicines

Most Recent Events

  • 23 Sep 2025 Planned End Date changed from 31 Jan 2028 to 23 Jun 2027.
  • 12 Jun 2025 According to a Blueprint Medicines media release, data from the trial will be reported at the 2025 European Hematology Association (EHA2025) Hybrid Congress, being held June 12 to 15 in Milan, Italy, and the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, being held June 13 to 16 in Glasgow, United Kingdom.
  • 01 May 2025 According to a Blueprint Medicines media release, data from the study were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) conference.

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