Phase 3 Study of QLG1074 Added to Standard Treatment for Active Lupus Nephritis to Improve Kidney Health Over 52 Weeks

What this Trial Is About

Researchers are evaluating the effectiveness of QL1074 compared with a placebo in achieving kidney improvement in people with active lupus nephritis over a 52-week treatment period. The study focuses on whether adding QL1074 to standard care, which includes mycophenolate mofetil and corticosteroids, can reduce disease activity and proteinuria levels. Participants must have a confirmed diagnosis of lupus nephritis with active kidney involvement based on clinical and biopsy findings. Participants will receive either oral QL1074 at a dose of 23.7 mg twice daily or a matching placebo for 52 weeks. All subjects will continue background therapy with mycophenolate mofetil and an initial intravenous methylprednisolone treatment followed by a tapering course of oral corticosteroids. Dose adjustments for QL1074 may occur based on safety concerns such as blood pressure or kidney function. The study is randomized, double-blind, and placebo-controlled. During the study, participants will undergo regular assessments including urine protein measurements, kidney function tests, and blood tests to monitor disease activity and safety. Researchers will evaluate outcomes such as complete kidney remission at week 52, changes in urine protein levels, and patient-reported outcomes. Safety will be closely monitored throughout the trial. The overall participation duration is about one year, and the study includes ongoing evaluations at multiple time points.

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