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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: 17 Dec 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

  • 05 Dec 2025 According to a Blueprint Medicines media release, data from this trial will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6 to 9 in Orlando, Florida.
  • 05 Dec 2025 Results published in the Media Release
  • 23 Sep 2025 Planned End Date changed from 31 Jan 2028 to 23 Jun 2027.

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