NCT07770815尚未招募3 期
A Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples
研究概览
简要总结
This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs).
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Source-verified, biopsy-confirmed IgA nephropathy (IgAN).
- •Receiving a stable and maximally tolerated dose of authorized angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) for at least 12 weeks.
- •Participants receiving a stable dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy for IgAN, if available, in addition to ACEIs and/or ARBs, must have initiated SGLT2i treatment for at least 12 weeks.
- •Participants must have a urine protein/creatinine ratio (uPCR) ≥ 0.75 grams per gram (g/g), as measured from the geometric mean of 3 first void spot urine samples (collected within the screening window prior to Dose 1).
- •Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).
- •No evidence of coexisting chronic kidney disease other than IgAN.
- •Serum immunoglobulin G (IgG) ≥ 600 mg/dL at screening.
- •Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.
排除标准
- 未提供
结局指标
主要结局
Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples
时间窗: Baseline, Week 40
Serum Concentration of Sibeprenlimab Through Week 52
时间窗: Baseline through Week 52
Change From Baseline in Serum Immunoglobulin A (IgA) Through Week 52
时间窗: Baseline through Week 52
次要结局
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Study Discontinuations Due to Adverse Events Through Week 60(Baseline through Week 60)
- Number of Participants With Clinically Significant Changes in Vital Signs Through Week 60(Baseline through Week 60)
- Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 60(Baseline through Week 60)
- Number of Participants With Clinically Significant Changes in Laboratory Assessments Through Week 60(Baseline through Week 60)
- Number of Injection Site Reactions Through Week 52(Baseline through Week 52)
- Number of Participants With Anti-Drug Antibody (ADA) From Baseline Through Week 60(Baseline through Week 60)
研究者
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