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
- 250
- 试验地点
- 1
- 主要终点
- AE profile and results of routine clinical and laboratory tests
研究概览
简要总结
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
详细描述
The purpose of this study is to evaluate the safety and efficacy of Atacicept in multiple autoimmune glomerular diseasing including:
- IgAN (IgA Nephropathy)
- pMN (Primary Membranous Nephropathy)
- MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight of at least 40 kg
- •On a stable prescribed standard of care (SoC) treatment regimen according to local guidelines and the specific requirements for each disease
- •Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at Screening.
- •Diagnosis of IgAN, IgAVN, pMN, MCD, FSGS, or primary nephrotic syndrome
- •For patients enrolling in IgAN cohorts (eligibility varies by cohort):
- •Age ≥ 18 years
- •Biopsy proven IgAN, IgAVN, or recurrent IgAN in kidney transplant
- •UPCR ≥ 0.5 g/g or UPE ≥ 0.5 g/day on 24h urine
- •eGFR≥ 20 mL/min/1.73m2
- •For patients enrolling in pediatric IgAN Cohorts (eligibility varies by cohort):
- •Age ≥ 2 years and < 18 years
- •Biopsy proven IgAN or IgAVN
- •On stable prescribed regimen of RAASi (or SoC) for at least 8 weeks
- •UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/d on 24h urine
- •eGFR≥ 30 mL/min/1.73m2
- •For patients enrolling in pMN cohorts (eligibility varies by cohort):
- •Age ≥ 18 years
- •Biopsy-proven pMN
- •Anti PLA2R antibodies ≥ 25 RU/mL
- •UPCR ≥ 1.5 g/g or UPE ≥ 1.5 g/d on 24h urine
- •At low risk for spontaneous remission (based on severity or duration of disease)
- •For patients enrolling in Nephrotic Syndrome cohorts (MCD, FSGS, or pediatric idiopathic nephrotic syndrome):
- •Age ≥ 10 years
- •eGFR ≥30 mL/min/1.73m2
- •Adults with biopsy diagnosis of primary MCD or FSGS (adults) or children with challenging clinical course with steroids (frequenlty relapsing, steroid-dependent, or steroid-resistant)
- •UPCR ≥ 1.0 g/g or UPE ≥ 1.0 g/d on 24h urine
- •Evidence of anti-nephrin antibodies
排除标准
- •Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR) within 12 weeks prior to and at Screening)
- •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
- •Immunosuppressant medications within 4 weeks prior to dosing with atacicept (except transplant maintenance immunosuppression).
- •Known hypersensitivity to atacicept or any component of the formulated atacicept
- •Additional criteria apply to each cohort/disease.
研究组 & 干预措施
IgAN or IgAVN
Adult and pediatric patients with biopsy proven IgAN or IgAVN with varied severity of proteinuria and kidney function beyond what is currently included in most clinical trials. Adults with post-transplant IgAN recurrence are also included.
干预措施: Atacicept (Drug)
pMN
Adults with biopsy-proven pMN associated with anti-PLA2R antibodies at low risk of spontaneous remission, or experiencing recurrent or resistant disease.
干预措施: Atacicept (Drug)
Primary Nephrotic Syndrome (MCD/FSGS)
Adults with biopsy-proven primary MCD or FSGS and evidence of anti-nephrin antibodies. Children with frequently relapsing, steroid-dependent, or non-genetic steroid-resistant nephrotic syndrome with evidence of anti-nephrin antibodies.
干预措施: Atacicept (Drug)
结局指标
主要结局
AE profile and results of routine clinical and laboratory tests
时间窗: Baseline until end of study: 52 + 26 Weeks
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), study drug discontinuation due to TEAEs
Percent reduction in urine protein to creatinine ratio (UPCR)
时间窗: Baseline, Week 36
Changes in proteinuria based on UPCR from 24 hour urine samples at baseline versus week 36
次要结局
- Changes from baseline estimated glomerular filtration rate (eGFR).(Baseline, Week 36, Week 52)
- Change in disease-specific antibodies(Baseline through 52 Weeks)