NCT07807995尚未招募3 期
A Phase 3, Single-Arm, Open-Label Extension Study Evaluating the Long-Term Safety and Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 605
- 主要终点
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the Week 104 visit in the parent study VX24-AIS-D08 (NCT06564142) and has not permanently discontinued study drug
- •Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 15 milliliters per minute (mL/min)/1.73 square meter (m^2) within 45 days of Day 1 of this study
排除标准
- •- Planned participation in another interventional, therapeutic clinical trial (other than the parent study).
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Povetacicept
Experimental
Participants will receive Povetacicept every 4 weeks (Q4W) for 104 weeks.
干预措施: Povetacicept (Drug)
结局指标
主要结局
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day 1 up to Week 112
次要结局
- Percentage Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR)(From Baseline through Week 104)
- Total Estimated Glomerular Filtration Rate (eGFR) Slope(From Baseline through Week 104)
- Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)(From Baseline through Week 104)
- Percent Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)(From Baseline through Week 104)
- Proportion of Participants to Achieve Hematuria Resolution(From Baseline through Week 104)
- Proportion of Participants Achieving Clinical Remission(From Baseline through Week 104)
- Time to Kidney Disease Progression(From Baseline through Week 104)
研究者
相似试验
Enrolling By Invitation
2 期
Open-Label Extension Study to Pioneer Study 6058-SCD-101Sickle Cell DiseaseNCT07401823Fulcrum Therapeutics50
已完成
3 期
Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn's Disease2024-511553-22-00Celgene International II SARL462
招募中
3 期
An Open-Label Extension Study of Fazirsiran2023-503497-21-00Takeda Development Center Americas Inc.18
招募中
3 期
Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.2023-510057-41-00Lib Therapeutics LLC590
尚未招募
3 期
To study if iptacopan is safe, tolerable and effective in patients with aHUSCTRI/2024/07/070874Novartis Healthcare Pvt Ltd100