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An Open Label Extension of SKY-0515 in Participants With Huntington's Disease
Sponsor: Skyhawk Therapeutics, Inc.
Summary
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.
Official title: An Open Label Extension of SKY-0515 in Participants With Huntington's Disease Who Completed a Prior SKY-0515 Treatment Study
Key Details
Gender
All
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-04-10
Completion Date
2029-12
Last Updated
2026-04-17
Healthy Volunteers
No
Conditions
Interventions
SKY-0515
Study Drug Name (INN): SKY-0515 Type: Drug (small molecule) Dosage Level(s): 9mg Route of Administration: Oral Dosage Frequency: Once daily Treatment Duration: until drug becomes commercially available or until the development of SKY-0515 is terminated by the Sponsor. Use: Experimental Sourcing: SKY-0515 will be provided centrally by the Sponsor or subsidiary, or designee Packaging and Labeling: Study drug will be provided in bottles labeled as required per country requirement. All packaging and labeling operations for the study drug will be performed according to current Good Manufacturing Practice for Medicinal Products and the relevant regulatory requirements.
Locations (4)
Westmead Hospital
Westmead, New South Wales, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Calvary Health Care Bethlehem
Caulfield South, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia