Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384547
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-22
Brief Title:
A Randomized Active Controlled Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease TED
Sponsor:
Viridian Therapeutics Inc
Organization:
Viridian Therapeutics Inc
Study Overview
Official Title:
A Randomized Active Controlled Safety and Tolerability Study of VRDN-001 a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor in Participants With Thyroid Eye Disease TED
Status:
RECRUITING
Status Verified Date:
2024-07
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:
STRIVE
Brief Summary:
The investigational drug VRDN-001 is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor IGF-1R Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease TED The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED
Detailed Description:
A randomized active controlled safety and tolerability study of VRDN-001 a humanized monoclonal antibody directed against the IGF-1 receptor in participants with thyroid eye disease TED
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?:
None
Is an FDA AA801 Violation?:
None