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

NCT06406205 Phase 3 RECRUITING

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.

Details

Lead sponsor	Qilu Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	270
Start date	2023-12-25
Completion	2028-06

Conditions

• Lupus Nephritis

Interventions

• Voclosporin（QL1074）
• Placebo

Primary outcomes

• Number of Participants With Complete Renal Remission at Week 52 — Week 52
  The primary efficacy endpoint was the number of subjects showing complete renal response at Week 52. Complete renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria： UPCR of ≤0.5 g/g \& eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20%

Countries

China