NCT07537075Enrolling by invitationPhase 2/3
An Extension of SKY-0515 in Participants With Huntington's Disease
An Open Label Extension of SKY-0515 in Participants With Huntington's Disease Who Completed a Prior SKY-0515 Treatment Study
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 3 Apr 2026
- Start date
- 10 Apr 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Skyhawk Therapeutics, Inc.
- Diseases
- Huntington's disease
- NCT number
- NCT07537075
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 500
- From 10 Apr 2026 to the primary completion date, 31 Dec 2029
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- -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.
Who the study is looking for
- 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.
Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Calvary Health Care Bethlehem Coordinator of this site? Confirm its status | Caulfield South | Australia | Unknown status |
| The University of Queensland Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| The Perron Institute for Neurology and Translational Science (Perron Institute) Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| John Hunter Hospital Coordinator of this site? Confirm its status | New Lambton Heights | Australia | Unknown status |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Huntington's Disease Association Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| New Zealand Brain and Research Institute Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Wellington Hospital Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.