NCT07378644 Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
| NCT ID | NCT07378644 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Skyhawk Therapeutics, Inc. |
| Condition | Huntington Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 400 participants in total. It began in 2026-01-06 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07378644 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, studying Huntington Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07378644 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07378644 currently recruiting?
Yes, NCT07378644 is actively recruiting participants. Contact the research team at sky0515trials@skyhawktx.com for enrollment information.
Where is the NCT07378644 trial being conducted?
This trial is being conducted at Englewood, United States, Boston, United States, Charlestown, United States, Columbus, United States and 11 additional locations.
Who is sponsoring the NCT07378644 clinical trial?
NCT07378644 is sponsored by Skyhawk Therapeutics, Inc.. The trial plans to enroll 400 participants.