Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514367
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2020-07-27
Brief Title:
An Open Label Study of ANX005 in Subjects With or at Risk for Manifest Huntingtons Disease
Sponsor:
Annexon Inc
Organization:
Annexon Inc
Study Overview
Official Title:
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 Huntingtons Disease
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multi-center open-label study of intravenous IV ANX005 in subjects with or at risk for manifest Huntingtons 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 Huntingtons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None