Under construction – not a live service
Sign in
Taking people in BrazilPhase 2/3

SKY-0515 pill for adults with Huntington's disease

Tests the oral drug SKY-0515 against placebo in adults with Huntington's disease.

Key facts

Who runs it
Skyhawk Therapeutics, Inc.
Where
Belo Horizonte, Campina Grande do Sul, Curitiba, Natal, Ribeirão Preto, Rio de Janeiro, and São Paulo, BrazilSee the 9 sitesAlso in 9 other countries, 28 sites
Registry title
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Status
Recruiting
Phase
Phase 2/3
People taking part
400 people, planned
Started
6 Jan 2026
Expected to end
Aug 2029
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • SKY-0515
  • SKY-0515 Placebo
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 25 and older with Huntington's Disease confirmed by a genetic test, who are still fairly independent in daily life.

Age
25 years or older
Sex
Men and women can join
Disease stage
Huntington's Disease with a Total Functional Capacity (TFC) score of 10 or more, a Total Motor Score (TMS) of 6 or more, and an Independence Score (IS) of 70 or more
Earlier treatment
No experimental drugs or other study in the last two months (longer for some drugs); no gene therapy of any kind
Biomarker or test result
Genetic test confirming Huntington's Disease, with a change in exon 1 of the HTT gene (CAG repeat of 40 or more)

Main reasons for not taking part

  • Other serious health problems or brain or spinal problems that could interfere with the study
  • Cancer now or in the last five years (some skin cancers are allowed)
  • History of suicidal thoughts, severe depression, or a suicide attempt in the past year
  • Positive for hepatitis B, hepatitis C, or HIV
  • Pregnancy, breastfeeding, or planning to become pregnant during the study

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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 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

Where in Brazil

Also in 9 other countries, 28 sites

  • Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERHBelo Horizonte, BrazilContact: Study Director, MDEnrolling by invitation
  • Hospital Angelina CaronCampina Grande do Sul, BrazilContact: Principal InvestigatorTaking people
  • Instituto de Neurologia de CuritibaCuritiba, BrazilContact: Vanessa RanduzTaking people
  • PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do ParanáCuritiba, BrazilContact: Principal InvestigatorTaking people
  • Hospital Universitário Onofre Lopes (HUOL)Natal, BrazilContact: Principal InvestigatorNot yet recruiting
  • Faculdade de Medicina de Ribeirão Preto - FMRPRibeirão Preto, BrazilContact: Principal InvestigatorNot yet recruiting
  • Hospital Universitario Pedro Ernesto (HUPE)Rio de Janeiro, BrazilContact: Principal InvestigatorTaking people
  • Hospital da Universidade Federal de São Paulo - UNIFESPSão Paulo, BrazilContact: Principal InvestigatorNot yet recruiting
  • PSEG Centro de Pesquisa ClinicaSão Paulo, BrazilContact: Study Director, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Active Comparator (1)Existing treatment, for comparison

    Dosage Level(s): Low Dose

    Treatment: SKY-0515

  • Active Comparator (2)Existing treatment, for comparison

    Dosage Level(s): Mid Dose

    Treatment: SKY-0515

  • Active Comparator (3)Existing treatment, for comparison

    Dosage Level(s): High Dose

    Treatment: SKY-0515

  • Placebo Comparator (4)Placebo, for comparison

    Matching placebo once daily oral

    Treatment: SKY-0515 Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
SKY-0515 pill for adults with Huntington's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026