NCT06500702招募中2 期
A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 84
- 试验地点
- 124
- 主要终点
- Percent reduction in urine protein to creatinine ratio (UPCR)
研究概览
简要总结
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig or rilzabrutinib compared with placebo in participants with primary FSGS or MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy report indicative of primary FSGS or MCD, with supportive clinical presentation per Investigator's judgement.
- •UPCR ≥3 g/g at screening, or ≥ 1.5 g/g in those with eGFR ≥ 60 mL/min/1.73 m
- •eGFR ≥45 mL/min/1.73 m^2 at screening.
- •Documented history of UPCR or UACR (or 24-hour urine protein or 24-hour urine albumin) reduction by >40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g or equivalent for UACR (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used or equivalent for 24-hr urine albumin if 24-hour urine albumin is used).
- •≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
- •For those on a RAAS inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.
- •For those on an SGLT2 inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting SGLT2 inhibitor treatment or changing the dose will not be allowed during the double-blind or OLE treatment periods.
- •Body weight within 45 to 120 kg (inclusive) at screening.
排除标准
- •Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
- •Collapsing variant of FSGS.
- •ESKD requiring dialysis or transplantation.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo
干预措施: placebo (Drug)
Frexalimab
Experimental
Frexalimab active dose
干预措施: frexalimab (Drug)
Brivekimig
Experimental
Brivekimig active dose
干预措施: brivekimig (Drug)
Rilzabrutinib
Experimental
Rilzabrutinib active dose
干预措施: rilzabrutinib (Drug)
结局指标
主要结局
Percent reduction in urine protein to creatinine ratio (UPCR)
时间窗: From baseline to Week 12
次要结局
- Percentage of participants achieving FSGS partial remission endpoint(At Week 12)
- Percentage of participants achieving CR(At Week 12)
- Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events (SAEs), treatment-emergent adverse events of special interest (AESIs) and IMP discontinuation due to TEAEs during the study(Treatment emergent period, up to Week 48)
- Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970(Up to Week 48)
- Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970(Up to Week 48)
研究者
研究点 (124)
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