RecruitingPhase 2Phase 3NCT07378644

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


Sponsor

Skyhawk Therapeutics, Inc.

Enrollment

400 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SKY-0515 and a drug called SKY-0515 Placebo for people with huntington disease. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 25 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKY-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

DRUGSKY-0515 Placebo

Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental


Locations(24)

CenExel Denver CO

Englewood, Colorado, United States

Hospital El Cruce

Buenos Aires, Buenos Aires, Argentina

Buenos Aires British Hospital

CABA, Buenos Aires, Argentina

IADIN (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

Hospital da Universidade Federal de São Paulo - UNIFESP

São Paulo, São Paulo, Brazil

PSEG Centro de Pesquisa Clinica

São Paulo, São Paulo, Brazil

North York General Hospital

Toronto, Ontario, Canada

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

CETRAM (Centro de Trastornos del Movimiento)

Santiago, Santiago Metropolitan, Chile

Clínica de la Costa S.A.S

Barranquilla, Atlántico, Colombia

Pineo Medical Ecosystem

Tbilisi, Georgia

Simon Khechinashvili University Hospital

Tbilisi, Georgia

Isar-Amper-Klinikum, Zentrum für Neuro- und Gerontopsychiatrie (ZNGP)

Taufkirchen, Germany

Hospital Universitario Ramon y Cajal

Madrid, Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07378644


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