SKY-0515 pill for adults with Huntington's disease
Tests the oral drug SKY-0515 against placebo in adults with Huntington's disease.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Key facts
- Where
- Boston, Charlestown, Columbus, and Englewood, United StatesSee the 4 sites
- Phase
- Phase 2/3
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesNot yet recruiting
- Massachusetts General HospitalCharlestown, United StatesNot yet recruiting
- The Ohio State UniversityColumbus, United StatesNot yet recruiting
- CenExel Denver, COEnglewood, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Skyhawk Therapeutics, Inc.
- Trial code
- NCT07378644EU 2025-522263-14-00
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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; History of suicidal thoughts, severe depression, or have attempted suicide in the past year; Positive for hepatitis B, hepatitis C, or HIV; Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe; Liver function tests show significant abnormalities; Pregnancy, breastfeeding, or planning to become pregnant during the study.