A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- argenx
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.
研究概览
简要总结
The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN.
While in the study, participants will continue to receive their usual medical care and medications for IgA nephropathy, unless the study doctor confirms otherwise.
The study will include a double blinded period, followed by an active drug period, and conclude with a follow up period. The total study duration for participants will be approximately 72 weeks, with a maximum of 52 weeks on ARGX-121.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females (not pregnant)
- •At least 18 years old
- •Clinically diagnosed with IgAN with biopsy confirmation
排除标准
- •Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN
- •Has secondary form of IgAN leading to IgA deposits
- •History of Malignancy
- •Active infection of concern
- •Recent Major surgery or organ transplant
研究组 & 干预措施
ARGX-121
Participants will receive ARGX-121 in subcutaneous injections during the double blinded treatment period and active only treatment periods (Total of 52 weeks)
干预措施: ARGX-121 (Biological)
Placebo followed by ARGX-121
Participants receive placebo for the double-blinded period of 24 weeks, followed by subcutaneous injections of ARGX-121 during the active only treatment period of 28 weeks.
干预措施: ARGX-121 (Biological)
Placebo followed by ARGX-121
Participants receive placebo for the double-blinded period of 24 weeks, followed by subcutaneous injections of ARGX-121 during the active only treatment period of 28 weeks.
干预措施: Placebo (Biological)
结局指标
主要结局
Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.
时间窗: Up to 24 weeks
UPCR is urine protein-to-creatinine ratio
次要结局
- Cmax (ARGX-121 maximum observed concentration) in serum(Up to 68 weeks)
- Percentage change in total IgA from baseline over time in serum(Up to 68 weeks)
- Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52(52 weeks)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 68 weeks)
- Percentage change in Gd-IgA1 from baseline over time in serum(Up to 68 weeks)
- Percentage change in total IgG from baseline over time in serum(Up to 68 weeks)
- Incidence of antidrug antibodies (ADA) against ARGX-121 in serum(Up to 68 weeks)