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.
- Diseases
- Huntington's disease
- 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
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital El Cruce Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| CINME Centro de Investigaciones Metabolicas Coordinator of this site? Confirm its status | Caba | Argentina | Recruiting |
| Sanatorio Mater Dei Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| IADIN (Instituto Argentino de Investigación Neurológica) Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Buenos Aires British Hospital Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Fundacion Scherbovsky Coordinator of this site? Confirm its status | Mendoza | Argentina | Recruiting |
| Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERH Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Enrolling by invitation |
| Hospital Angelina Caron Coordinator of this site? Confirm its status | Campina Grande do Sul | Brazil | Recruiting |
| PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do Paraná Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Instituto de Neurologia de Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Hospital Universitário Onofre Lopes (HUOL) Coordinator of this site? Confirm its status | Natal | Brazil | Not yet recruiting |
| Faculdade de Medicina de Ribeirão Preto - FMRP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Not yet recruiting |
| Hospital Universitario Pedro Ernesto (HUPE) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Hospital da Universidade Federal de São Paulo - UNIFESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| PSEG Centro de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| North York General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Pontificia Universidad Catolica de Chile Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| CETRAM (Centro de Trastornos del Movimiento) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Clínica de la Costa S.A.S Coordinator of this site? Confirm its status | Barranquilla | Colombia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| St. Josef Hospital Coordinator of this site? Confirm its status | Bochum | Germany | Not yet recruiting |
| Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. Coordinator of this site? Confirm its status | Bonn | Germany | Not yet recruiting |
| Huntington-Zentrum Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Not yet recruiting |
| George-Huntington-Institut GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Not yet recruiting |
| kbo-Isar-Amper-Klinikum gGmbH Coordinator of this site? Confirm its status | Taufkirchen (Vils) | Germany | Not yet recruiting |
| University Hospital Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Not yet recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| University College of London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Neuroclnx Coordinator of this site? Confirm its status | Motherwell | United Kingdom | Recruiting |
| Pineo Medical Ecosystem Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Simon Khechinashvili University Hospital Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Charlestown | United States | Not yet recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| CenExel Denver, CO Coordinator of this site? Confirm its status | Englewood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.