A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

Lupus Nephritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

• NCT number: NCT06406205
• Study type: Interventional
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Feng Guo
• Phone: 0531-55821177
• Email: feng11.guo@qilu-pharma.com
• Status: Recruiting
• Phase: Phase 3
• Start date: December 25, 2023
• Completion date: June 2028