Phase 3 Huntington's Disease Trial, Recruiting NCT07378644 Sponsor: Skyhawk Therapeutics, Inc. Condition: Huntington's Disease
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Phase 3 Huntington's Disease Trial, Recruiting

NCT07378644
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 25 years old or older.
  • You have been diagnosed with Huntington's Disease confirmed by a genetic test, showing a specific gene change (CAG repeat of 40 or more in the HTT gene).
  • Your level of day-to-day functioning, as measured by a standard Huntington's scale called the Total Functional Capacity score, is 10 or above (confirm with trial site).
  • Your movement and motor symptoms, as measured by a standard score called the Total Motor Score, are rated 6 or above (confirm with trial site).
  • Your ability to live independently, as measured by an Independence Score, is rated 70 or above (confirm with trial site).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting and use two forms of birth control during the study and for 30 days after your last dose.
  • If you are a man, you must agree to use birth control during the study and for 90 days after your last dose.
  • You are willing to sign a consent form and follow all study rules and appointments.

Who may not be able to join:

  • You have other serious health problems or conditions affecting the brain or spine that could interfere with the study or make it unsafe for you.
  • You have a condition or implanted medical device that makes it difficult or impossible to have an MRI scan.
  • You have been diagnosed with cancer in the last five years (some minor skin cancers may be exceptions — confirm with trial site).
  • You have severe allergies or have had a serious reaction to similar drugs in the past.
  • You are currently taking medications or receiving treatments that could interfere with the study.
  • You have taken part in another clinical trial or taken an experimental drug within the last two months, or longer depending on the drug involved.
  • You have previously received any form 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 currently pregnant, breastfeeding, or planning to become pregnant during the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 6178580041

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Skyhawk Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
6 January 2026
Est. completion
1 December 2028

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇬🇪 Georgia

Primary endpoints

Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov