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New pill aims to tame Huntington's disease by targeting toxic proteins

NCT ID NCT06873334

Disease control Sponsor: Skyhawk Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an oral drug called SKY-0515 in 120 adults with Huntington's disease. The goal is to see if it can lower harmful proteins in the blood, slow brain changes, and improve symptoms. Participants must be 25 or older with a confirmed genetic diagnosis and a certain level of independence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * You must be 25 years or older. * You must have Huntington's Disease confirmed through genetic testing, with a specific gene change (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. * You must agree to sign a consent form and follow the study's rules and schedule. Exclusion Criteria: * You have other serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe. * You have a condition that interferes with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI. * You have cancer, except for some types of skin cancer, or a history of cancer in the last five years. * You have severe allergies or have reacted badly to similar drugs in the past. * You are taking medications or treatments that might interfere with the study. * You've been in another study or taken experimental drugs in the last two months (or longer for some drugs). * You have had any kind of gene therapy. * You have a history of suicidal thoughts, severe depression, or have attempted suicide in the past year. * Your liver function tests show significant abnormalities. * You have tested positive for hepatitis B, hepatitis C, or HIV. * You are pregnant, breastfeeding, or planning to become pregnant during the study.

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Conditions

The condition(s) this trial relates to.

choreatic disease Huntington disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Huntington disease Huntingtons disease

Contacts and locations

Locations

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Calvary Health Care Bethlehem

    Caulfield South, Victoria, 3162, Australia

  • Christchurch Neurology Trials Limited

    Christchurch, 8011, New Zealand

  • Flinders Medical Centre

    Adelaide, South Australia, 5042, Australia

  • Huntington's Disease Association

    Auckland, 0604, New Zealand

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305, Australia

  • Launceston General Hospital

    Launceston, Tasmania, 7250, Australia

  • The Perron Institute for Neurology and Translational Science (Perron Institute)

    Nedlands, Western Australia, 6009, Australia

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • The University of Queensland

    Herston, Queensland, 4006, Australia

  • Wellington Hospital

    Wellington, 6021, New Zealand

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

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