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Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Sponsor: Skyhawk Therapeutics, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-01-06
Completion Date
2029-08
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
SKY-0515
Type: Small molecule Dosage Level(s): Low, mid, high Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental
SKY-0515 Placebo
Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental
Locations (19)
IADIN (Instituto Argentino de Investigación Neurológica)
Buenos Aires, Buenos Aires, Argentina
Buenos Aires British Hospital
CABA, Buenos Aires, Argentina
Instituto Argentino de Investigación Neurológica
CABA, Buenos Aires, Argentina
CINME Centro de Investigaciones Metabólicas
CABA, Buenos Aires, Argentina
Sanatorio Mater Dei
CABA, Buenos Aires, Argentina
Fundación Scherbovsky
Mendoza, Mendoza Province, Argentina
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
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
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
PSEG Centro de Pesquisa Clinica
São Paulo, São Paulo, Brazil
Clinical Hospital FMUSP (Hospital das Clínicas da Universidade de São Paulo)
São Paulo, São Paulo, Brazil
North York General Hospital
Toronto, Ontario, Canada
CETRAM (Centro de Trastornos del Movimiento)
Santiago, Santiago Metropolitan, Chile
Pineo Medical Ecosystem
Tbilisi, Georgia
Simon Khechinashvili University Hospital
Tbilisi, Georgia