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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 Jun 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

  • 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.
  • 13 Feb 2025 According to a Blueprint Medicines media release, Three-year safety and efficacy data from this study will be presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress.

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