Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406205
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-20
Brief Title:
A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis
Sponsor:
Qilu Pharmaceutical Co Ltd
Organization:
Qilu Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Study Comparing the Efficacy and Safety of QLG1074 With Placebo in Achieving Renal Remission in Subjects With Active Lupus Nephritis
Status:
RECRUITING
Status Verified Date:
2024-05
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 assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis
Detailed Description:
The aim of the current study is to investigate whether QL1074 added to the standard of care treatment in active lupus nephritis LN is able to reduce disease activity over a treatment period of 52 weeks The background therapy will be mycophenolate mofetil MMF and initial treatment with IV methylprednisolone followed by a reducing course of oral corticosteroids Subjects with active LN will be eligible to enter the study They are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria as measured by Urine Protein Creatinine Ratio UPCR while demonstrating an acceptable safety profile
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