NCT04514367

An Open Label Study of ANX005 in Subjects With, or at Risk for, Manifest Huntington's Disease

A Phase 2a Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ANX005 in Subjects With, or at Risk for, Manifest Huntington's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, open-label study of intravenous (IV) ANX005 in subjects with, or at risk for, manifest Huntington's Disease (HD).

Detailed description

The objective of this study is to evaluate the effects of intravenous ANX005 administered for up to 22 weeks in subjects with, or at risk for, manifest Huntington's Disease. Subjects will receive induction dosing of ANX005 administered by IV infusion on Days 1 and 5 or 6, followed by maintenance dosing every 2 weeks through Week 22, with follow up visits on Weeks 24, 28, and 36. All subjects will be contacted (in clinic visit or phone call) 6 months after study completion.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	ANX005	Intravenous Infusion

Timeline

• Start date: 2020-08-17
• Primary completion: 2022-01-28
• Completion: 2022-01-28
• First posted: 2020-08-14
• Last updated: 2023-01-31

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study