Continued Treatment With SKY-0515 for People With Huntington's Disease
Tests SKY-0515, taken by mouth, in adults with Huntington's disease from an earlier study.
Plain-language title generated from the registry record
Registry title: An Extension of SKY-0515 in Participants With Huntington's Disease
Key facts
- Where
- Adelaide, Caulfield South, Herston, Nedlands, New Lambton Heights, Parkville, and Westmead, AustraliaSee the 7 sites
- Phase
- Phase 2/3
Where in Australia
- Flinders Medical CentreAdelaide, AustraliaNo longer taking part
- Calvary Health Care BethlehemCaulfield South, AustraliaNo longer taking part
- The University of QueenslandHerston, AustraliaNo longer taking part
- The Perron Institute for Neurology and Translational Science (Perron Institute)Nedlands, AustraliaNo longer taking part
- John Hunter HospitalNew Lambton Heights, AustraliaNo longer taking part
- The Royal Melbourne HospitalParkville, AustraliaNo longer taking part
- Westmead HospitalWestmead, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Skyhawk Therapeutics, Inc.
- Trial code
- NCT07537075
- Record updated
- 24 July 2026
- Original description
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.Read full original descriptionShow less
An Open Label Extension of SKY-0515 in Participants With Huntington's Disease Who Completed a Prior SKY-0515 Treatment Study
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.
Inclusion: Must have completed treatment in a prior SKY-0515 treatment study and, in the opinion of the Investigator, have been compliant with the prior SKY-0515 treatment protocol study procedures; Must be able and willing to meet all study requirements in the opinion of the Investigator including:; Participants must be able to tolerate blood draws; Willing and able to comply with all scheduled visits, treatment plans,laboratory tests and other study procedures; Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug; Men must agree to use birth control during the study and for 90 days after the last dose.
Exclusion: -Have any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.