An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases (RUBY-3)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 30
- 主要终点
- Part A: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis - LN), or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) to determine if povetacicept is safe and potentially beneficial in treating these diseases.
During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52-week treatment extension period. Participants with IgAN and pMN may also receive povetacicept for an additional 52 weeks, if eligible.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Povetacicept
Part A: Participants will receive povetacicept for 24 weeks with the possibility of participating in treatment extensions through 104 weeks of treatment.
Part B: Participants with IgAN and pMN will receive povetacicept for an additional 52 weeks.
干预措施: Povetacicept (Drug)
结局指标
主要结局
Part A: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Study Day 1 Through 24 Weeks After Last Dose Of Study Drug
Part B: Safety as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Study Day 1 Through 12 Weeks After Last Dose Of Study Drug
次要结局
- Part A: Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept(Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
- Part B: Incidence and Titer of Anti-drug Antibodies (ADA) Against Povetacicept(Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)
- Part A: Time Required for Povetacicept To Reach Half its Concentration (t1/2)(Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
- Part B: Time Required for Povetacicept To Reach Half its Concentration (t1/2)(Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)
- Part A: Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE).(Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
- Part B: Change from Baseline in Serum Ig Isotypes (IgM, total IgA, IgA1, IgA2, total IgG, IgG1, IgG2, IgG3, IgG4, IgE)(Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)
- Part A: Change from Baseline in Peripheral Blood Lymphocytes and Subsets(Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
- Part B: Change from Baseline in Peripheral Blood Lymphocytes and Subsets(Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)
- Part A:Change from Baseline Over Time In Circulating Levels Of anti-dsDNA in LN; galactose deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 in IgAN; anti-PLA2R1 or anti THSD7A in pMN and anti-PR3 or anti-MPO in AAV(Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
- Part B: Change from Baseline Over Time In Circulating Levels Of galactose deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 in IgAN; anti-PLA2R1 or anti THSD7A in pMN(Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)
- Part A: Change From Baseline Over Time In Complement Components (C3, C4, CH50)(Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
- Part B: Change From Baseline Over Time In Complement Components (C3, C4, CH50)(Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)
- Part A: Immunological Remission (pMN only)(Study Day 1 Through Week 24 After Dose of Study Drug)
- Part B: Immunological Remission (pMN only)(Study Day 1 Through Week 12 After Dose of Study Drug)
- Part A: Change from Baseline at Week 24 in UPCR (Urine protein/creatinine ratio) (based on assessment of 24-hour urine)(Baseline and at Week 24)
- Part A: Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)(Baseline and at Week 24)
- Part B: Change from Baseline at Week 24 in Estimated Glomerular Filtration Rate (eGFR)(Baseline and at Week 24)
- Part A: Renal Response(At Week 24)
- Part A: Remission of Vasculitis (Birmingham Vasculitis Activity Score (BVAS = 0)) (for AAV cohorts only)(At Week 24)
- Part A: Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept(Study Day 1 Through 24 Weeks After Last Dose Of Study Drug)
- Part B: Changes in Biomarkers Including Cytokines and Autoantibodies After Treatment with Povetacicept(Study Day 1 Through 12 Weeks After Last Dose Of Study Drug)