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Study of SKY-0515 for Safety, Efficacy, and Pharmacodynamics 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: A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Key Details
Gender
All
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-05-27
Completion Date
2027-12
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
SKY-0515
Study Drug Name (INN): SKY-0515 Type: Drug (small molecule) Dosage Level(s): Low, mid, high Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 12 months 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 blinded 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.
SKY-0515 Placebo
Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 12 months Use: Experimental Sourcing: SKY-0515 placebo will be provided centrally by the Sponsor or subsidiary, or designee Packaging and Labeling: Study drug will be provided in blinded 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 (11)
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
Auckland City Hospital
Auckland, New Zealand
Christchurch Neurology Trials Limited
Christchurch, New Zealand
Wellington Hospital
Wellington, New Zealand