Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248619
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-01-31
Brief Title:
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Randomized Double-masked Placebo-controlled Parallel-group Multicenter Trial to Evaluate the Efficacy Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The study consists of a randomized double-masked placebo-controlled parallel-group multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period
Detailed Description:
The main objective of the study is to evaluate the effect of teprotumumab subcutaneous administration versus placebo on the proptosis responder rate ie the percentage of participants with a 2-mm reduction from Baseline in the study eye without deterioration 2-mm increase of proptosis in the fellow eye at Week 24
Acquired from Horizon in 2024
Acquired from Horizon in 2024
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