Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-25
Brief Title:
A Study of IBI311 in Subjects With Steroid-resistant Thyroid Associated Ophthalmopathy
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
An Exploratory Study of the Efficacy and Safety of IBI311 a Modified Anti-IGF-1R Antibody in Patients With Steroid-resistant Thyroid Associated Ophthalmopathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 is an exploratory study of the efficacy and safety of IBI311 a modified anti-IGF-1R antibody in patients with steroid-resistant thyroid associated ophthalmopathy TAO This study includes two stages Stage I is a single-center single-arm open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO Approximately 10 subjects meeting the study eligibility criteria will be enrolled Stage II is a single-center randomized double-masked placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 D1 in a 21 ratio stratified by disease activity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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