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

RecruitingPhase 2, Phase 3Ages 25 Years - anyAllSkyhawk Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • SKY-0515
  • SKY-0515 Placebo
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Where

31 sites
CenExel Denver CO
Englewood, United States
Beth Israel Deaconess Medical Center
Boston, United States
Massachusetts General Hospital
Charlestown, United States
The Ohio State University
Columbus, United States
Hospital El Cruce
Buenos Aires, Argentina
Buenos Aires British Hospital
CABA, Argentina
IADIN (Instituto Argentino de Investigación Neurológica)
CABA, Argentina
CINME Centro de Investigaciones Metabólicas
CABA, Argentina

…and 23 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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