SKY-0515-008

9 evidence topics · 1 source

Objective

Long-term safety, tolerability, and efficacy

“This is an OLE study to investigate the long-term safety, tolerability, and efficacy of SKY-0515 administered orally in participants with HD.” (opens the source at this quote in a new tab)

Location and study date

Study dates and countries

Item	Registry record
Study start (actual)	“2026-04-10”
Primary completion (estimated)	“2029-12”
Countries	“Australia”· “New Zealand”

Study design

Open-label extension design

“An Open Label Extension of SKY-0515 in Participants With Huntington's Disease Who Completed a Prior SKY-0515 Treatment Study” (opens the source at this quote in a new tab)

Eligibility criteria

Completion of a prior SKY-0515 study

“Must have completed treatment in a prior SKY-0515 treatment study and, in the opinion of the Investigator, have been compliant with the prior SKY-0515 treatment protocol study procedures.” (opens the source at this quote in a new tab)

Treatment

Open-label 9 mg once daily

“participants will be consented to enter the OLE study and initiate open label treatment with 9 mg tablets of SKY-0515. Open label SKY-0515 will be self-administered daily (QD).” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using long-term safety and tolerability as the primary endpoint

Primary outcome definition

“To investigate the long-term safety and tolerability of SKY-0515 through the Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (including withdrawals due to TEAEs)” (opens the source at this quote in a new tab)

Secondary efficacy assessments schedule

“Every 3 months for the first year, beginning with enrollment, then every six months for approximately 36 months.” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment

Enrollment type	Participants
Estimated	“500”

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary

This single-group, open-label extension has no concurrent control and has reported no results. All participants receive 9 mg once daily regardless of prior assignment, so longer-term efficacy outcomes will be difficult to separate from natural history and expectation effects; its primary contribution will be long-term safety data over approximately 36 months in up to an estimated 500 participants.