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RECRUITING
NCT06873334
PHASE2/PHASE3

Study of SKY-0515 for Safety, Efficacy, and Pharmacodynamics in Participants With Huntington's Disease

Sponsor: Skyhawk Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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