An Extension of SKY-0515 in Participants With Huntington's Disease

Enrolling by invitation · Phase 2/Phase 3

Conditions studied: Huntington's Disease (HD)

In brief

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.

Key facts

Study ID

NCT07537075

Run by

Skyhawk Therapeutics, Inc.

People needed

500

Starts

2026-04-10

Expected to finish

2029-12-01

Last updated by the study team

2026-07-24

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• John Hunter Hospital — New Lambton Heights, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• The University of Queensland — Herston, Queensland, Australia
• Flinders Medical Centre — Adelaide, South Australia, Australia
• Calvary Health Care Bethlehem — Caulfield South, Victoria, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• The Perron Institute for Neurology and Translational Science (Perron Institute) — Nedlands, Western Australia, Australia
• Huntington's Disease Association — Auckland, New Zealand
• New Zealand Brain and Research Institute — Christchurch, New Zealand
• Wellington Hospital — Wellington, New Zealand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.