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

Sponsor
Skyhawk Therapeutics, Inc.
Study ID
NCT07378644
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SKY-0515 — DRUG
    Type: Small molecule Dosage Level(s): Low, mid, high Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental
  • SKY-0515 Placebo — DRUG
    Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental

Study Details

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 Dates

Start date
Jan 6, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Comparator (1)
    Dosage Level(s): Low Dose
  • Active Comparator: Active Comparator (2)
    Dosage Level(s): Mid Dose
  • Active Comparator: Active Comparator (3)
    Dosage Level(s): High Dose
  • Placebo Comparator: Placebo Comparator (4)
    Matching placebo once daily oral

Primary Outcome Measure

Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS) [ Time Frame: 72 weeks ]

Central Contacts

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