Huntington DiseasePhase 2/3FALCON-HDNCT07378644
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
A Phase 2/3 study testing SKY-0515 in people with Huntington Disease, run by Skyhawk Therapeutics, Inc. at 31 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- SKY-0515
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 31 sitesin 10 countries
- Study dates
- 6 Jan 2026to Aug 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe.
- 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.
- 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).
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- Any kind of gene therapy.
- History of suicidal thoughts, severe depression, or have attempted suicide in the past year.
- Liver function tests show significant abnormalities.
- Positive for hepatitis B, hepatitis C, or HIV.
- Pregnancy, breastfeeding, or planning to become pregnant during the study.
Trial locations and contacts
31 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 10 countries
Brazil9 sites, 8 recruiting
- Enrolling by invitation
Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERH
Belo Horizonte, Minas Gerais, 30130-100
- Recruiting
Hospital Angelina Caron
Campina Grande do Sul, Paraná, 83430-000
Principal Investigator, (41) 3679-8100
Giorgio Fabiani
- Recruiting
PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, 80215-901
Principal Investigator, 41 3271 1515
Gustavo Franklin
- Recruiting
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310
Vanessa Randuz, +554130288545, vanessa.radunz@pesquisacuritiba.com
Pedro André Kowacs
- Not yet recruiting
Hospital Universitário Onofre Lopes (HUOL)
Natal, Rio Grande do Norte, 59010-056
Principal Investigator, +55 84 3342-5000, clecio.godeiro@ufrn.br
Clecio Godeiro
- Not yet recruiting
Faculdade de Medicina de Ribeirão Preto - FMRP
Ribeirão Preto, São Paulo, 14049-900
Principal Investigator, 55 16 3963-6486, "tumasv@fmrp.usp.br" <tumasv@fmrp.usp.br>
Vitor Tumas
- Recruiting
Hospital Universitario Pedro Ernesto (HUPE)
Rio de Janeiro, Rio de Janiero, 20550
Principal Investigator, +55 21 2868-8000
Principal Investigator
- Not yet recruiting
Hospital da Universidade Federal de São Paulo - UNIFESP
São Paulo, São Paulo, 04024-002
Principal Investigator
Roberta Saba, MD
- Active, not recruiting
PSEG Centro de Pesquisa Clinica
São Paulo, São Paulo, 04038002
Argentina6 sites, 6 recruiting
- Recruiting
Hospital El Cruce
Buenos Aires, Buenos Aires, B1888AAE
Cintia Amato, +54 9 11 6805-2782, cintia.amato@hospitalelcruce.org
Soledad Fernández, soledad.fernandez@hospitalelcruce.org
- Recruiting
Buenos Aires British Hospital
CABA, Buenos Aires, 1280AEB
Elizabeth Varela, +54 9 11 2309 1096, EVARELA@hbritanico.com.ar
Marcela Claudia Uribe Roca
- Recruiting
IADIN (Instituto Argentino de Investigación Neurológica)
CABA, Buenos Aires, C1015ABR
Karina Barroso, +54 9 11 6174-3158, karibarroso@yahoo.com.ar
Luciana lugonzalezgarretto@hotmail.com - + Garretto, +54 9 11 4445-2383, lugonzalezgarretto@hotmail.com
- Recruiting
CINME Centro de Investigaciones Metabólicas
CABA, Buenos Aires, C1056 AB
Principal Investigator, +54 9 1150596124
Camila Di Nucci Traverso, +54 9 11 3668-7207, cdinuccitraverso@cinme.com.ar
- Recruiting
Sanatorio Mater Dei
CABA, Buenos Aires, C1425
Denise Pamela Paredes, +54 9 11 5663 6092, denisepamelaparedes@gmail.com
Emilia Gatto
- Recruiting
Fundación Scherbovsky
Mendoza, Mendoza Province, M5500
Mariangeles Samudio, +54 9 261 654-0777, m.samudio@fundacionscherbovsky.com
Sebastian Gustavo Rauek
United States4 sites, 4 recruiting
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 43221
Noundy Mazile, 617-667-2355, Nmazile@bidmc.harvard.edu
Aine Russell, 617-667-2351, Arussel2@bidmc.harvard.edu
- Not yet recruiting
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Herminia Diana Rosas, PhD, 617-643-5694, Hrosas@mgh.harvard.edu
Herminia D Rosas, MD
- Not yet recruiting
The Ohio State University
Columbus, Ohio, 43221
Sarah Smith, 614-293-4078, Sarah.Smith1@osumc.edu
Simon Laganiere, MD
- Recruiting
CenExel Denver CO
Englewood, Colorado, 80113
Liza Heap, +1 303 762 6674, e.heap@cenexel.com
Meagan Salinas, MD
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
JOSE ESTEBAN MUÑOZ, +34-932275785, SECRETARIANEUROLOGIA@clinic.cat
Jose Esteban MUÑOZ
- Not yet recruiting
Sant Pau Hospital
Barcelona, 08040
Jesús Pérez Pérez, +34 635163029, jperezp@santpau.cat
Gonzalo Olmedo-Sauras, +34 635163029, golmedo@santpau.cat
- Not yet recruiting
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Jose Luis Lopez-Sendon Moreno, jlsendonmoreno@salud.madrid.org
Jose Luis Lopez-Sendon Moreno
Chile2 sites, 2 recruiting
- Recruiting
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8331150
Principal Investigator
Carlos Andrés Juri Clavería
- Recruiting
CETRAM (Centro de Trastornos del Movimiento)
Santiago, Santiago Metropolitan, 9120500
Maria Consuelo Moos Migueles, +56 9 2278337, estudiosclinicos@cetram.cl
Pedro Chaná Cuevas
Georgia2 sites, 2 recruiting
- Recruiting
Pineo Medical Ecosystem
Tbilisi
Sophia Sopromadze, MD, +995 599 360 430, sophias@pineo.ge
Sophia Sopromadze, MD
- Recruiting
Simon Khechinashvili University Hospital
Tbilisi
Irine Khatiashvili, MD, Ph.D, +995577786578, irenekhat@yahoo.com
Irine Khatiashvili, MD, PhD
United Kingdom2 sites, 2 recruiting
- Recruiting
University College of London
London, WC1N 3BG
Serwaa Lashley, akosuaserwaa.lashley@nhs.net
Ed Wild
- Recruiting
NeuroClnx
Motherwell, Lanarkshire, ML1 4UF
Monica Harley, 0141 948 0206, Monica.harley@neuroclnx.co.uk
Erin Mccrone, 0141 948 0206, Erin.mccrone@neuroclnx.co.uk
Canada1 site, 1 recruiting
- Recruiting
North York General Hospital
Toronto, Ontario, M2K 1E1
Clare Gibbons, 416-756-6788, clare.gibbons@nygh.on.ca
Danica Nogo, danica.nogo@nygh.on.ca
Colombia1 site, 1 recruiting
- Recruiting
Clínica de la Costa S.A.S
Barranquilla, Atlántico, 5001000
Principal Investigator
Laureano Caparroso
Germany1 site, 1 recruiting
- Not yet recruiting
Isar-Amper-Klinikum, Zentrum für Neuro- und Gerontopsychiatrie (ZNGP)
Taufkirchen, 84416
Alzbeta Mühlbäck, +8084-934 125, zngp-ambulanz@kbo.de
Katherine Kämpchen, +8084-934 495, zngp-ambulanz@kbo.de
About this study
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
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.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled trial conducted across multiple sites. This clinical trial aims to evaluate the safety, pharmacodynamics, and efficacy of SKY-0515, a novel, orally administered small molecule. Huntington's Disease (HD) is a rare, inherited neurodegenerative condition caused by a mutation in the huntingtin (HTT) gene, resulting in excessive production of mutant huntingtin (mHTT) protein, which damages nerve cells and leads to progressive motor, cognitive, and psychiatric symptoms. SKY-0515 is designed to reduce mHTT protein levels, leading to a decrease in both wild-type and mutant forms of HTT protein. Additionally, the drug lowers postmeiotic segregation 1 (PMS1) protein, which plays a role in somatic CAG repeat expansion-a key driver of HD progression. Participants must be aged 25 or older, have genetically confirmed HD (CAG repeat length ≥ 40), and meet specific functional and motor criteria. They will be assigned randomly to one of four treatment arms (three doses of SKY-0515 and one placebo group). Safety and efficacy will be evaluated through blood tests, imaging (MRI), and clinical assessments, including the Unified Huntington's Disease Rating Scale (UHDRS).
- Conditions
- Huntington Disease
- Being tested
- SKY-0515, SKY-0515 Placebo
- Keywords
- SKY-0515, Skyhawk, HTT, Neurodegenerative, Huntington Disease, mRNA, Splicing, Mutant Huntingtin protein
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY-0515Drug
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 PlaceboDrug
Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator (1) | Active comparator | Dosage Level(s): Low Dose Receives: Drug: SKY-0515 |
| Active Comparator (2) | Active comparator | Dosage Level(s): Mid Dose Receives: Drug: SKY-0515 |
| Active Comparator (3) | Active comparator | Dosage Level(s): High Dose Receives: Drug: SKY-0515 |
| Placebo Comparator (4) | Placebo comparator | Matching placebo once daily oral Receives: Drug: SKY-0515 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS)
cUHDRS includes the Total Functional Capacity (range, 0-13; higher score means better functioning), Total Motor Score (range, 0-124; higher score means worse motor severity), Symbol Digit Modality Test (range, 0-110, correctly paired numbers-symbols in 90 seconds; higher score means better cognitive performance), and Stroop Color and Word Test (range, 0-no max value, correctly read color words in 45 seconds; higher score means better cognitive performance) scores. A z-score for each test is calculated, which alone can be used to describe relationship between an individual's test score and the mean score of a target population. A z-score of 0 is the mean, and ±1 is 1 standard deviation from the mean. For cUHDRS, z-scores of each test are summed, whereby a higher cUHDRS score is better (score of -3.06-no max value) and a change of ≥1.2 is a meaningful worsening, shown to track functional decline.
Measured: 72 weeks
Secondary outcomes (5)
Change from Baseline in Total Motor Score (TMS)
The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment score is the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.
Measured: 72 weeks
Change from Baseline in Total Functional Capacity (TFC)
TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Measured: 72 weeks
Change from Baseline in Independence Scale Score (IS)
The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.
Measured: 72 weeks
Change from Baseline in Symbol Digit Modalities Test (SDMT)
The SDMT assesses attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The score is the number of correctly paired abstract symbols and specific numbers in 90 seconds with higher scores indicating better cognitive functioning.
Measured: 72 weeks
Change from Baseline in the Stroop Color and Word Test (SCWT)
In the Stroop Color and Word Test (SCWT) the number of words and colors read correctly is counted, with a higher score indicating better cognitive performance scores. There is no upper limit for SWR as it is a time-based task. The lower limit (worst possible) however is 0; higher score is better meaning less severity.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start6 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo-controlled dose ranging
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skyhawk Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378644
- Sponsor's protocol ID
- SKY-0515-004-WW
- Acronym
- FALCON-HD
- Status last verified
- Nov 2026
- First submitted
- 13 Jan 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07378644
- Acronym / sponsor ID
- FALCON-HD / SKY-0515-004-WW
- Conditions
- Huntington Disease
- Keywords
- SKY-0515, Skyhawk, HTT, Neurodegenerative, Huntington Disease, mRNA, Splicing, Mutant Huntingtin protein
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Skyhawk Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled trial conducted across multiple sites. This clinical trial aims to evaluate the safety, pharmacodynamics, and efficacy of SKY-0515, a novel, orally administered small molecule. Huntington's Disease (HD) is a rare, inherited neurodegenerative condition caused by a mutation in the huntingtin (HTT) gene, resulting in excessive production of mutant huntingtin (mHTT) protein, which damages nerve cells and leads to progressive motor, cognitive, and psychiatric symptoms. SKY-0515 is designed to reduce mHTT protein levels, leading to a decrease in both wild-type and mutant forms of HTT protein. Additionally, the drug lowers postmeiotic segregation 1 (PMS1) protein, which plays a role in somatic CAG repeat expansion-a key driver of HD progression. Participants must be aged 25 or older, have genetically confirmed HD (CAG repeat length ≥ 40), and meet specific functional and motor criteria. They will be assigned randomly to one of four treatment arms (three doses of SKY-0515 and one placebo group). Safety and efficacy will be evaluated through blood tests, imaging (MRI), and clinical assessments, including the Unified Huntington's Disease Rating Scale (UHDRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind placebo-controlled dose ranging
| Arm | Type | Receives |
|---|---|---|
| Active Comparator (1) | Active comparator | Drug: SKY-0515Dosage Level(s): Low Dose |
| Active Comparator (2) | Active comparator | Drug: SKY-0515Dosage Level(s): Mid Dose |
| Active Comparator (3) | Active comparator | Drug: SKY-0515Dosage Level(s): High Dose |
| Placebo Comparator (4) | Placebo comparator | Drug: SKY-0515 PlaceboMatching placebo once daily oral |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (11 listed)
- Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe.
- 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.
- Taking medications or treatments that might interfere with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKY-0515Type: Small molecule Dosage Level(s): Low, mid, high Route of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental | Drug | Active Comparator (1), Active Comparator (2), Active Comparator (3) |
| SKY-0515 PlaceboRoute of Administration: Oral Dosage Frequency: Once daily Blinded Treatment Duration: 18 months Use: Experimental | Drug | Placebo Comparator (4) |
Primary outcome
Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS)
Time frame: 72 weeks
cUHDRS includes the Total Functional Capacity (range, 0-13; higher score means better functioning), Total Motor Score (range, 0-124; higher score means worse motor severity), Symbol Digit Modality Test (range, 0-110, correctly paired numbers-symbols in 90 seconds; higher score means better cognitive performance), and Stroop Color and Word Test (range, 0-no max value, correctly read color words in 45 seconds; higher score means better cognitive performance) scores. A z-score for each test is calculated, which alone can be used to describe relationship between an individual's test score and the mean score of a target population. A z-score of 0 is the mean, and ±1 is 1 standard deviation from the mean. For cUHDRS, z-scores of each test are summed, whereby a higher cUHDRS score is better (score of -3.06-no max value) and a change of ≥1.2 is a meaningful worsening, shown to track functional decline.
5 secondary outcomes
Change from Baseline in Total Motor Score (TMS)
Time frame: 72 weeks
Change from Baseline in Total Functional Capacity (TFC)
Time frame: 72 weeks
Change from Baseline in Independence Scale Score (IS)
Time frame: 72 weeks
Change from Baseline in Symbol Digit Modalities Test (SDMT)
Time frame: 72 weeks
Change from Baseline in the Stroop Color and Word Test (SCWT)
Time frame: 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Skyhawk Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SKY-0515 in people with Huntington Disease, run by Skyhawk Therapeutics, Inc. at 31 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Brazil, Argentina, United States, Spain, Chile and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director, MD (6178580041, sky0515trials@skyhawktx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS) (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.