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NCT07378644RecruitingPhase 2/3

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

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

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
400 (estimated)
First submitted
13 Jan 2026
Start date
6 Jan 2026
Primary completion date
31 Dec 2028
Lead sponsor
Skyhawk Therapeutics, Inc.
NCT number
NCT07378644
EU CT number
2025-522263-14-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 400
  • From 6 Jan 2026 to the primary completion date, 31 Dec 2028
  • 37 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital El Cruce
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
CINME Centro de Investigaciones Metabolicas
Coordinator of this site? Confirm its status
CabaArgentinaRecruiting
Sanatorio Mater Dei
Coordinator of this site? Confirm its status
CABAArgentinaRecruiting
IADIN (Instituto Argentino de Investigación Neurológica)
Coordinator of this site? Confirm its status
CABAArgentinaRecruiting
Buenos Aires British Hospital
Coordinator of this site? Confirm its status
CABAArgentinaRecruiting
Fundacion Scherbovsky
Coordinator of this site? Confirm its status
MendozaArgentinaRecruiting
Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERH
Coordinator of this site? Confirm its status
Belo HorizonteBrazilEnrolling by invitation
Hospital Angelina Caron
Coordinator of this site? Confirm its status
Campina Grande do SulBrazilRecruiting
PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do Paraná
Coordinator of this site? Confirm its status
CuritibaBrazilRecruiting
Instituto de Neurologia de Curitiba
Coordinator of this site? Confirm its status
CuritibaBrazilRecruiting
Hospital Universitário Onofre Lopes (HUOL)
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NatalBrazilNot yet recruiting
Faculdade de Medicina de Ribeirão Preto - FMRP
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Ribeirão PretoBrazilNot yet recruiting
Hospital Universitario Pedro Ernesto (HUPE)
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilRecruiting
Hospital da Universidade Federal de São Paulo - UNIFESP
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São PauloBrazilNot yet recruiting
PSEG Centro de Pesquisa Clinica
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São PauloBrazilActive, not recruiting
North York General Hospital
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TorontoCanadaRecruiting
Pontificia Universidad Catolica de Chile
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SantiagoChileRecruiting
CETRAM (Centro de Trastornos del Movimiento)
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SantiagoChileRecruiting
Clínica de la Costa S.A.S
Coordinator of this site? Confirm its status
BarranquillaColombiaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyNot yet recruiting
St. Josef Hospital
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BochumGermanyNot yet recruiting
Deutsches Zentrum für Neurodegenerative Erkrankungen e. V.
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BonnGermanyNot yet recruiting
Huntington-Zentrum Lübeck
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LübeckGermanyNot yet recruiting
George-Huntington-Institut GmbH
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MuensterGermanyNot yet recruiting
kbo-Isar-Amper-Klinikum gGmbH
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Taufkirchen (Vils)GermanyNot yet recruiting
University Hospital Ulm
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UlmGermanyNot yet recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainNot yet recruiting
University College of London
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LondonUnited KingdomRecruiting
Neuroclnx
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MotherwellUnited KingdomRecruiting
Pineo Medical Ecosystem
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TbilisiGeorgiaRecruiting
Simon Khechinashvili University Hospital
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TbilisiGeorgiaRecruiting
Beth Israel Deaconess Medical Center
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BostonUnited StatesNot yet recruiting
Massachusetts General Hospital
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CharlestownUnited StatesNot yet recruiting
The Ohio State University
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ColumbusUnited StatesNot yet recruiting
CenExel Denver, CO
Coordinator of this site? Confirm its status
EnglewoodUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.