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

Launched by SKYHAWK THERAPEUTICS, INC. · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new oral medication called SKY-0515 to see if it can reduce harmful proteins linked to Huntington's Disease (HD) and help improve symptoms for people living with this condition. The study is looking for men and women aged 25 and older who have been genetically tested and confirmed to have HD. To qualify, participants need to meet specific health criteria, including having a certain level of physical ability and independence.

If you or a loved one is interested in participating, it's important to know that the trial is not yet recruiting, and there are specific requirements to be eligible. For instance, participants must have a certain genetic marker for HD and a minimum score on tests that measure daily functioning and motor skills. Women who can become pregnant will need to take precautions, while men also must follow specific guidelines regarding birth control. The study will involve regular visits and tests, and participants will need to agree to follow the study rules closely. This trial offers a potential opportunity to contribute to research that may lead to better treatments for Huntington's Disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • You must be 25 years or older.
• • You must have Huntington's Disease confirmed through genetic testing, with a specific gene change (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.
• • You must agree to sign a consent form and follow the study's rules and schedule.
• Exclusion Criteria:
• • You have other serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe.
• • You have a condition that interferes with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.
• • You have cancer, except for some types of skin cancer, or a history of cancer in the last five years.
• • You have severe allergies or have reacted badly to similar drugs in the past.
• • You are taking medications or treatments that might interfere with the study.
• • You've been in another study or taken experimental drugs in the last two months (or longer for some drugs).
• • You have had any kind of gene therapy.
• • You have a history of suicidal thoughts, severe depression, or have attempted suicide in the past year.
• • Your liver function tests show significant abnormalities.
• • You have tested positive for hepatitis B, hepatitis C, or HIV.
• • You are pregnant, breastfeeding, or planning to become pregnant during the study.