In short
SKY-0515 is an investigational medicine being studied for Huntington’s disease, a rare inherited condition that damages nerve cells in the brain. One clinical trial is registered for this substance, a Phase 4 study that plans to enrol 456 participants. The trial will measure how SKY-0515 affects disease characteristics over 72 weeks using a scale called cUHDRS.
Key points
- SKY-0515 is being studied in Huntington’s disease, a rare inherited brain disorder.
- The registered trial is a Phase 4 study, meaning it takes place after initial approval or in a later stage of research.
- The study plans to enrol 456 participants and is currently authorised to begin.
- SKY-0515 is given as tablets taken by mouth, in three strengths: 4 mg, 6 mg and 9 mg.
- The main measure is the change in the cUHDRS score from the start of treatment to Week 72.
What is SKY-0515?
SKY-0515 is an investigational medicine. The clinical trial registry does not provide a marketing authorisation record for this substance, which means it is still being studied and is not yet approved as a medicine. The registry gives no other names, development codes or trade names for SKY-0515 beyond this identifier. The substance is being investigated in Huntington’s disease, a rare inherited condition that causes the progressive breakdown of nerve cells in the brain.
How does SKY-0515 work?
The registry record for this trial does not describe the mechanism of action of SKY-0515 — that is, how the substance acts in the body at a molecular level. The trial is designed to investigate the effects of SKY-0515 on disease characteristics of Huntington’s disease, but the specific biological target or pathway is not stated in the available data.
Which conditions is SKY-0515 studied for?
- Huntington’s disease — a rare inherited disorder in which nerve cells in the brain break down over time, leading to movement, thinking and emotional problems. This is the only condition listed for the registered trial of SKY-0515.
How is SKY-0515 given?
SKY-0515 is given as tablets that are taken by mouth (oral use). The trial lists three tablet strengths: 4 mg, 6 mg and 9 mg. The trial also includes a comparison arm with micronized methylcellulose spray-dried intermediate in enteric-coated tablets, which serves as the comparator rather than as the studied substance.
What do the clinical trials show?
There is one registered clinical trial for SKY-0515. It is a Phase 4 study, meaning it is being conducted at a later stage of clinical research. The trial is currently authorised, which means it has received approval to begin but results are not yet available. It is an interventional study, meaning participants receive the medicine and are then followed over time.
The study plans to enrol 456 participants with Huntington’s disease. The main measure, called the primary outcome, is the change from the start of treatment to Week 72 in a scale called cUHDRS (composite Unified Huntington’s Disease Rating Scale). This scale combines several measures of movement, thinking and day-to-day function into a single score, so a change in the score reflects how the disease is progressing overall.
The registry record does not give details about who can take part, such as age limits or specific disease stages, beyond the condition itself being Huntington’s disease.
What side effects are known?
The trial registry record does not list any side effects for SKY-0515. Because the substance is still investigational and no results have been published in the registry, no safety information is available from this source.