2024-518465-10-00招募中2 期
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 37
- 主要终点
- Change from baseline in UPCR at Week 36
研究概览
简要总结
To evaluate the safety and tolerability of atacicept
To evaluate the effect of atacicept on change from baseline in proteinuria
研究设计
- 分配方式
- Not Applicable
- 主要目的
- 26-week Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •For All Participants: On stable prescribed SoC treatment regimen according to local guidelines and the specific requirements for each disease/cohort listed in Section 4 of the protocol
- •Systolic BP ≤160 mmHg and diastolic BP ≤90 mmHg at Screening. For participants aged ≥10 to <18 years, the average of 3 separate systolic and/or diastolic blood pressures <95th percentile for age, gender, and height
- •Weight ≥40 kg at Screening
- •Willing to comply with the contraceptive guidelines of protocol
- •IgAN specific: Biopsy proven IgAN or IgAVN, UPCR ≥ 0.5 to ≥ 5 g/g, eGFR≥ 20 pMN specific: ≥ 18 yrs of age, Diagnosis of anti-PLA2R pMN on biopsy,Anti PLA2R≥ 25 RU/mL,UPCR ≥ 1.5 g/g MCD/FSGS/Nephrotic Syndrome: eGFR≥30 mL/min/1.73m2, Biopsy diagnosis of primary MCD or FSGS, UPCR ≥ 1.0 g/g at Screening, eGFR ≥30 mL/min/1.73m2, Evidence of anti-nephrin antibodies
排除标准
- •For All Participants: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months prior to and at Screening)
- •Severe kidney impairment (eGFR <15 mL/min/1.73 m2) or receiving dialysis or kidney replacement therapy or other organ transplantation prior to, or expected during the study, with the exception of corneal transplants
- •Mixed or multiple glomerulopathies >50% tubulointerstitial fibrosis or ≥ 25% cellular crescents on biopsy
- •Active viral or bacterial infections
- •Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
- •Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
- •Known hypersensitivity to atacicept or any component of the formulated atacicept
- •Additional criteria apply to each cohort/disease.
结局指标
主要结局
Change from baseline in UPCR at Week 36
Change from baseline in UPCR at Week 36
次要结局
- Changes from baseline in Gd-IgA1 (IgAN) or anti-PLA2R (pMN)
- Changes from baseline in eGFR (CKD-EPI) at Weeks 36 and 52
- Change from baseline in UPCR at Week 52 (IgAN cohorts), or Weeks 12, 24, and 52 (pMN and NS cohorts)
- Serum concentration of atacicept throughout the entire study
- Proportion of participants achieving proteinuric responses defined in Table 3 at Weeks 24, 36, and 52
研究者
Pamela Winterberg
Scientific
Vera Therapeutics Inc.
研究点 (37)
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