Clinical Trial

Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease

Study acronym: FALCON-HD
Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.
Protocol Amendment History 2 changes
notable Trial sites expanded: 10 -> 19 locations 2026-07-14
notable Trial sites expanded: 4 -> 8 locations 2026-06-05
Trial Details
NCT Number NCT07378644
Lead Sponsor Skyhawk Therapeutics, Inc.
Conditions Huntington Disease
Enrollment 400 participants
Start Date 2026-01-06
Primary Completion 2028-12 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-13