The study is a Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with lupus nephritis (LN). It adopts a randomized, double-blind, placebo-controlled, multicenter trial design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
SHR-2173 injection.
SHR-2173 injection blank preparation.
The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
Nanjing, Jiangsu, China
RECRUITINGThe ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.
Time frame: At Week 24.
The proportion of subjects achieving complete renal response (CRR).
Time frame: At Week 24 and Week 52.
The proportion of subjects achieving partial renal response (PRR).
Time frame: At Week 24 and Week 52.
The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline.
Time frame: At Week 24 and Week 52.
The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline.
Time frame: At Week 24 and Week 52.
The proportion of subjects whose 24-hour UPCR was less than 0.5 g/g.
Time frame: At Week 24 and Week 52.
The proportion of subjects whose 24-hour UPCR was less than 0.7 g/g.
Time frame: At Week 24 and Week 52.
The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg/day.
Time frame: At Week 24 and Week 52.
The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg/day.
Time frame: At Week 24 and Week 52.
The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline.
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Time frame: At Week 24 and Week 52.
Adverse events (AEs).
Time frame: Up to 52 weeks.