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

Study acronym: Falcon-HD
StatusActive, Not Recruiting
PhasePhase 2/3
Started2025-05-27
View on ClinicalTrials.gov ↗

Amendment history

2026-04-30
Study Status, Contacts/Locations v10
Trial status changed: Recruiting → Active, Not Recruiting
Study sitesdetails revised at 12 of 12 sites
2026-04-21
Study Status, Contacts/Locations v9
Study sites11→12
2026-01-29
Study Status, Contacts/Locations v8
Study sites10→11
2025-11-14
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 10 sites
2025-10-02
Study Status, Contacts/Locations v6
Study sitesdetails revised at 7 of 10 sites
Show 5 earlier versions
2025-07-08
Study Status, Contacts/Locations v5
Study sites10 entries, revised
The University of Queensland - Royal Brisbane Womens Hospital
2025-06-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05→confirmed 2025-05-27
Study sitesdetails revised at 10 of 10 sites
2025-05-04
Study Identification, Study Status, Contacts/Locations v3
Study sitescontacts updated at 10 of 10 sites
2025-04-15
Study Status, Contacts/Locations v2
Study sitesdetails revised at 1 of 10 sites
2025-04-10
Study Identification, Study Status, Contacts/Locations v1
Study sitesdetails revised at 8 of 10 sites
Study titlerevised
Study of SKY-0515 for Safety, Efficacy, and Pharmacodynamics in Participants withWith Huntington's Disease
2025-03-06
Original filing
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.
Trial Details
NCT Number NCT06873334
Lead Sponsor Skyhawk Therapeutics, Inc.
Conditions Huntington Disease, Huntingtons Disease
Enrollment 120 participants
Start Date 2025-05-27
Primary Completion 2027-05 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-01