A study of QLG1074 combined with background therapy in subjects with active lupus nephritis
A study of QLG1074 combined with background therapy in subjects with active lupus nephritis
ClinicalTrials.gov ID: NCT06406205
Sponsor: Qilu Pharmaceutical Co., Ltd.
Information provided by: Qilu Pharmaceutical Co., Ltd. (Responsible Party)
Last Update Posted: 2024-05-09
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.
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
Intervention / Treatment:
- Drug: Voclosporin（QL1074）
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-12-25
|
| Primary Completion (Estimated) |
2027-06-01
|
| Study Completion (Estimated) |
2028-06-01
|
| Enrollment (Estimated) | 270 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
QLG1074-301
|