NCT07614477招募中2 期
The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)
Everest Medicines (China) Co.,Ltd.2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年5月20日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
研究概览
简要总结
This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at ~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Primary FSGS or MCD/IgAN confirmed by renal biopsy
- •eGFR ≥ 45 mL/min/1.73 m²
- •For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) > 3.5 g/g and serum albumin < 30 g/L during the screening period
- •For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
- •Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment
排除标准
- •Hereditary or secondary FSGS/MCD; collapsing FSGS
- •BMI ≥ 35 kg/m² in participants with FSGS/MCD
- •Evidence of diabetes mellitus or a history of diabetes mellitus
- •Acute or chronic infection requiring treatment
- •Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
- •Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
- •At risk of bleeding
- •Baseline 24-hour UPCR > 3 g/g and serum albumin < 30 g/L in participants with IgAN
研究组 & 干预措施
EVER001 200mg bid
Experimental
Participants in this arm receive EVER001 200 mg administered twice daily (bid) orally. This single-arm cohort evaluates the efficacy and safety of EVER001 in subjects with FSGS, MCD, and IgA
干预措施: EVER001 (Drug)
研究者
研究点 (2)
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