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

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522263-14-00

Enrollment

Registered

2026-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington’s Disease

Brief summary

Change from baseline to Week 72 in cUHDRS.

Detailed description

Change from baseline to Week 72 in: − Total motor score (TMS) − Total functional capacity (TFC) − Independence scale (IS) − Stroop Color and Word test (SCWT) − Symbol digital modalities test (SDTM)

Interventions

DRUGSKY-0515 9 mg tablet

DRUGMicronized methylcellulose spray-dried intermediate in enteric-coated tablets

DRUGSKY-0515 4 mg tablet

DRUGSKY-0515 6 mg tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 72 in cUHDRS.	—

Secondary

Measure	Time frame
Change from baseline to Week 72 in: − Total motor score (TMS) − Total functional capacity (TFC) − Independence scale (IS) − Stroop Color and Word test (SCWT) − Symbol digital modalities test (SDTM)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 24, 2026