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Clinical Trials in the EU / 2025-522263-14-00
Authorised Phase III

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

2025-522263-14-00 · tracked via the Priya Life Science EU tracker
Sponsor
Skyhawk Therapeutics Inc.
Sponsor type
Pharmaceutical company
Therapeutic area
Nervous System Diseases
Decision date
23/07/2026
Enrollment target
110
Sites
Germany, Spain

Condition studied

Huntington’s Disease

Investigational medicinal product(s)

SKY-0515 9 mg tabletMicronized methylcellulose spray-dried intermediate in enteric-coated tabletsSKY-0515 4 mg tabletSKY-0515 6 mg tablet

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Change from baseline to Week 72 in cUHDRS.

Endpoint detail

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)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522263-14-00 on CTIS ↗ ← All trials in the EU