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.
Age 18-70 years (inclusive) at informed consent signing, regardless of sex;
Body weight ≥ 40.0 kg and body mass index (BMI) ≥ 16 kg/m² to ≤ 28 kg/m² at screening;
Diagnosed with systemic lupus erythematosus (SLE) per 1997 ACR criteria or 2019 EULAR/ACR classification criteria;
Positive antinuclear antibody (titer ≥ 1:80) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening;
Received renal dialysis within 12 months preceding screening, or anticipated requirement for dialysis/renal transplantation within 6 months post-enrollment;
Renal biopsy demonstrating > 50% globally sclerosed glomeruli;
Active severe/unstable neuropsychiatric SLE (NPSLE);
Catastrophic antiphospholipid syndrome (APS) within 12 months pre-screening, or APS-related thrombotic events (except non-catastrophic/mild APS cases with stable anticoagulation ≥12 weeks prior to screening);
Parallel
SHR-2173 Injection
DrugSHR-2173 injection.
SHR-2173 Injection Blank Preparation
DrugSHR-2173 injection blank preparation.
The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.
The proportion of subjects achieving complete renal response (CRR).
The proportion of subjects achieving partial renal response (PRR).
The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline.
The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline.
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