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Phase 2/3Recruiting

Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease (FALCON-HD)

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

Sponsor
Skyhawk Therapeutics, Inc. (Industry)
Enrollment
400 planned
Conditions
Huntington Disease
Interventions
SKY-0515; SKY-0515 Placebo
Ages
adults, older adults
Registry
NCT07378644

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Registered

  5. Started