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RECRUITING
NCT07378644
PHASE2/PHASE3

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

Sponsor: Skyhawk Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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