Actively Recruiting
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Led by Skyhawk Therapeutics, Inc. · Updated on 2026-04-21
400
Participants Needed
4
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 25 years or older.
- Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).
- Total Functional Capacity (TFC) score of 10 or more).
- Total Motor Score (TMS) of 6 or more).
- Independence Score (IS) of 70 or more).
- 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.
- Agree to sign a consent form and follow the study's rules and schedule.
You will not qualify if you...
- Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe.
- Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.
- Cancer, except for some types of skin cancer, or a history of cancer in the last five years.
- Severe allergies or have reacted badly to similar drugs in the past.
- Taking medications or treatments that might interfere with the study.
- Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).
- Any kind of gene therapy.
- History of suicidal thoughts, severe depression, or have attempted suicide in the past year.
- Liver function tests show significant abnormalities.
- Positive for hepatitis B, hepatitis C, or HIV.
- Pregnancy, breastfeeding, or planning to become pregnant during the study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
CINME Centro de Investigaciones Metabólicas
Buenos Aires, Argentina, C1056 AB
Actively Recruiting
2
PSEG Centro de Pesquisa Clinica
São Paulo, São Paulo, Brazil, 04038002
Not Yet Recruiting
3
Pineo Medical Ecosystem
Tbilisi, Georgia
Actively Recruiting
4
Simon Khechinashvili University Hospital
Tbilisi, Georgia
Actively Recruiting
Research Team
S
Study Director, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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