Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07378644 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: FALCON-HD
StatusRecruiting
PhasePhase 2/3
Started2026-01-06
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 22 sites
2026-08-24
Study Status, Contacts/Locations v10
Study sites22 entries, revised
InstitutoHospital ArgentinoEl de Investigación NeurológicaCruce
2026-08-20
Study Status, Contacts/Locations v9
Trial sites expanded: 19 → 22 locations
Study sites22 entries, revised
Clinical Hospital FMUSP (Hospital das Clínicas da Universidade Federal de São Paulo) - UNIFESP
2026-08-18
Study Status, Contacts/Locations v8
Study sites19→22
2026-07-09
Study Status, Contacts/Locations v7
Trial sites expanded: 10 → 19 locations
Show 4 earlier versions
2026-06-30
Study Status, Contacts/Locations v6
Study sitesdetails revised at 7 of 10 sites
2026-06-25
Study Status, Contacts/Locations v5
Study sites9→10
2026-06-23
Study Status, Contacts/Locations v4
Study sites8→9
2026-06-10
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 8 sites
2026-06-02
Study Status, Contacts/Locations v2
Trial sites expanded: 4 → 8 locations
2026-04-17
Study Status, Contacts/Locations v1
Study sites2→4
2026-01-22
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 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 2026-09-21