NCT07393451尚未招募2 期
A Randomized, Double-blind, Placebo, Parallel-Controlled, Multicenter Phase 2a Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of SIM0278 in Subjects With Active Lupus Nephritis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving an overall renal response (complete renal response (CRR) + partial renal response (PRR)) at Week 52
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult (18-75 years) subjects with active LN suitable for systemic therapy.
Approximately 60 subjects with active LN are planned to be enrolled and randomized 1: 1 to SIM0278 or placebo.
The study consists of 3 phases: screening, double-blind treatment, and safety follow-up.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight ≥ 40.0 kg
- •SLE was diagnosed according to 2019 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria.
- •Subjects must be receiving or willing to initiate induction therapy for LN. Induction therapy, defined as including high-dose glucocorticoids and MMF, should be initiated within 60 days or on the same day prior to baseline.
排除标准
- •Previous or current nephropathy (except LN) that, in the opinion of the investigator, may interfere with the LN assessment and interfere with the assessment of disease activity (e.g., diabetic nephropathy). The subject was unable or unwilling to provide written informed consent and/or to comply with study procedures.
- •Severe renal impairment: a) oliguria (defined as recorded urine volume < 400 mL/24 h), or b) end-stage renal disease (ESRD) requiring dialysis or transplantation.
- •Previous induction therapy for MMF/MPS was considered by the investigator to have failed.
研究组 & 干预措施
Test group
Experimental
Cohort 1- Test group
干预措施: SIM0278 injection (Drug)
Control group
Experimental
Cohort 2- Control group
干预措施: SIM0278 injection (Drug)
结局指标
主要结局
Proportion of subjects achieving an overall renal response (complete renal response (CRR) + partial renal response (PRR)) at Week 52
时间窗: At Week 52
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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