A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 11
- 主要终点
- Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept
研究概览
简要总结
This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean eGFR greater than or equal to 30 mL/min/1.73m2
- •Clinical evidence of active kidney disease
- •Treated with supportive care including an ACE inhibitor or ARB if applicable
- •Willing to receive required vaccinations
- •Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy
排除标准
- •Previous kidney transplant or major solid organ transplant
- •Required renal replacement therapy for more than 72 hours
- •Rapidly progressive glomerular nephritis or acute kidney injury
- •History of recurrent invasive infection
- •Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)
- •Active TB, HIV or other systemic infection
- •Abnormal liver function
研究组 & 干预措施
Part B - ADX-038 Combination Therapy
干预措施: Telitacicept (Drug)
Part B - ADX-038 Combination Therapy
干预措施: ADX-038 (Drug)
Part A - ADX-038 Monotherapy
干预措施: ADX-038 (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept
时间窗: Part A - 24 Months and Part B - 15 months
Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.
次要结局
未报告次要终点