NCT07229742招募中2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Active Lupus Nephritis
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2025年11月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Histologically confirmed active lupus nephritis (LN) class III or IV ± class V by renal biopsy, per 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) standards within 1 year preceding or during screening.
排除标准
- •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);
- •Non-LN renal diseases potentially confounding disease assessment (e.g., diabetic nephropathy per investigator judgment);
- •Inflammatory/autoimmune diseases beyond SLE/LN that may interfere with efficacy/safety interpretation.
研究组 & 干预措施
SHR-2173 Injection Group
Experimental
干预措施: SHR-2173 Injection (Drug)
SHR-2173 Injection Placebo Group
Placebo Comparator
干预措施: SHR-2173 Injection Blank Preparation (Drug)
结局指标
主要结局
The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.
时间窗: At Week 24.
次要结局
- The proportion of subjects whose 24-hour UPCR was less than 0.5 g/g.(At Week 24 and Week 52.)
- The proportion of subjects whose 24-hour UPCR was less than 0.7 g/g.(At Week 24 and Week 52.)
- The proportion of subjects achieving complete renal response (CRR).(At Week 24 and Week 52.)
- The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline.(At Week 24 and Week 52.)
- The proportion of subjects achieving partial renal response (PRR).(At Week 24 and Week 52.)
- The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline.(At Week 24 and Week 52.)
- The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg/day.(At Week 24 and Week 52.)
- The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg/day.(At Week 24 and Week 52.)
- The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline.(At Week 24 and Week 52.)
- Adverse events (AEs).(Up to 52 weeks.)
研究者
研究点 (1)
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