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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Huntington Disease

In brief

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.

Key facts

Study ID

NCT07378644

Run by

Skyhawk Therapeutics, Inc.

People needed

400

Starts

2026-01-06

Expected to finish

2029-08-01

Last updated by the study team

2026-07-13

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• Fundación Scherbovsky — Mendoza, Mendoza Province, Argentina (enrolling)
• Buenos Aires British Hospital — CABA, Buenos Aires, Argentina (enrolling)
• Instituto Argentino de Investigación Neurológica — CABA, Buenos Aires, Argentina (enrolling)
• PSEG Centro de Pesquisa Clinica — São Paulo, São Paulo, Brazil (enrolling)
• CINME Centro de Investigaciones Metabólicas — CABA, Buenos Aires, Argentina (enrolling)
• Sanatorio Mater Dei — CABA, Buenos Aires, Argentina (enrolling)
• CETRAM (Centro de Trastornos del Movimiento) — Santiago, Santiago Metropolitan, Chile (enrolling)
• Pineo Medical Ecosystem — Tbilisi, Georgia (enrolling)
• Simon Khechinashvili University Hospital — Tbilisi, Georgia (enrolling)
• North York General Hospital — Toronto, Ontario, Canada
• Instituto de Neurologia de Curitiba — Curitiba, Paraná, Brazil
• Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERH — Belo Horizonte, Minas Gerais, Brazil
• Hospital Angelina Caron — Campina Grande do Sul, Paraná, Brazil
• PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do Paraná — Curitiba, Paraná, Brazil
• IADIN (Instituto Argentino de Investigación Neurológica) — Buenos Aires, Buenos Aires, Argentina
• Hospital Universitario Pedro Ernesto (HUPE) — Rio de Janeiro, Rio de Janiero, Brazil
• Hospital Universitário Onofre Lopes (HUOL) — Natal, Rio Grande do Norte, Brazil
• Faculdade de Medicina de Ribeirão Preto - FMRP — Ribeirão Preto, São Paulo, Brazil
• Clinical Hospital FMUSP (Hospital das Clínicas da Universidade de São Paulo) — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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