Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525506
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-Masked Phase II Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized double-masked phase II study evaluating the efficacy and safety of IBI311 in subjects with inactive or active thyroid eye disease Approximately 36 subjects meeting the study eligibility criteria will be randomly assigned to the 3-10 mg group 3-20 mg group 10 mg group or 20 mg group on day 1 in a 1122 ratio Dose conversion of the 3-10 mg or 3-20 mg group was performed at week 12 Active and inactive TED was a stratification factor in this study Active and inactive TED subjects were enrolled in a 11 ratio
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None