Clinical Trial

Screening Study for KIT D816V Mutated Mast Cell Disease in Select Populations

Study acronym: POLARIS
Recruiting
View on ClinicalTrials.gov →
Summary
This is a multicenter screening study to characterize the prevalence of the KIT D816V mutation in participants with suspected clonal mast cell disease.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-08-13
notable Enrollment increased: 450 -> 750 participants 2026-08-13
minor Trial arms changed: 3 -> 4 2026-08-13
notable Trial sites expanded: 19 -> 22 locations 2026-08-13
Trial Details
NCT Number NCT07143669
Lead Sponsor Blueprint Medicines Corporation
Conditions Clonal Mast Cell Disease, KIT D816V Mutation, Suspected KITD816V Mutated Clonal Mast Cell Disease
Enrollment 750 participants
Start Date 2025-10-17
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-12