Phase 2 / Phase 3: testing SKY-0515 for Huntington 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.
Official registry: https://clinicaltrials.gov/study/NCT07378644 · Skyhawk Therapeutics, Inc. · enrollment listed as 400
What this phase means
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are SKY-0515, or SKY-0515 Placebo. The registry lists allocation as randomized. 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.
They plan to enroll about 400 people at 31 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: SKY-0515, SKY-0515 Placebo
Primary outcome (registry wording): Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS)
Who it is for (from inclusion criteria)
- Ages 25 Years to any
- 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 the registry excludes
- 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)
- Any kind of gene therapy
Public study contact (from the registry)
Study Director, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
31 listed- CenExel Denver CO — Englewood, Colorado (recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts (not_yet_recruiting)
- Massachusetts General Hospital — Charlestown, Massachusetts (not_yet_recruiting)
- The Ohio State University — Columbus, Ohio (not_yet_recruiting)
+ 27 sites outside the US on the same record
FAQ about this NCT record
Is NCT07378644 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07378644?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07378644?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary