Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680480
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2022-12-26
Brief Title:
A Study of Telitacicept in Lupus Nephritis
Sponsor:
RemeGen Co Ltd
Organization:
RemeGen Co Ltd
Study Overview
Official Title:
A Phase Ⅱ Multicenter Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis
Status:
RECRUITING
Status Verified Date:
2024-09
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 purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis
Detailed Description:
This is a phase 2 multicentre randomised double-blind placebo-controlled study to evaluate the efficacy and safety of telitacicept versus placebo while taking standard of care SOC treatment in adult subjects with active proliferative lupus nephritis LN
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