NCT05248646进行中（未招募）3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Otsuka Pharmaceutical Development & Commercialization, Inc.454 个研究点 分布在 5 个国家目标入组 530 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 530
- 试验地点
- 454
- 主要终点
- Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
研究概览
简要总结
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q 4 weeks compared to placebo in patients with IgAN. The primary objective is to compare the relative change from baseline in the urinary protein to creatinine ratio (uPCR) in 24-hour urine collections, after 9 months of treatment. The key secondary objective is to compare the annualized rate of change from baseline (slope) of estimated glomerular filtration rate (eGFR) after approximately 24 months of treatment. There will be one main cohort comprised of approximately 450 subjects with source-verified biopsy-confirmed IgAN and eGFR ≥ 30 mL/min/1.73 m^2. An additional exploratory cohort will be comprised of up to 20 subjects with source-verified biopsy confirmed IgAN and eGFR of 20 to < 29 mL/min/1.73 m^2.
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
- Double (Participant, Investigator)
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
- •Male and female patients ≥ 18 years of age .
- •Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
- •Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
- •Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
- •eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the 2021 CKD-EPI equation
排除标准
- •Secondary forms of IgAN or IgA vasculitis.
- •Coexisting chronic kidney disease other than IgAN.
- •Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
- •Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
- •Nephrotic syndrome
- •Serum IgG < 600 mg/dL at screening.
- •Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
- •Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
- •Chronic infectious disease, or acute infectious disease at time of screening.
- •Type 1 diabetes, or poorly controlled Type 2 diabetes
- •Uncontrolled hypertension
- •The protocol provides additional information about these and other inclusion and exclusion criteria.
研究组 & 干预措施
Sibeprenlimab 400 mg s.c. q 4weeks
Active Comparator
干预措施: Sibeprenlimab 400 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
时间窗: At 9 months
次要结局
- Annualized rate of change from baseline (slope) of eGFR(Over 24 months)
- Annualized rate of change (slope) of eGFR(Over 24 months)
- Mean change of eGFR from baseline(Over 24 months)
- Progression to composite kidney failure (CKF)(Time from the randomization date to first occurrence of CKF)
- Percentage of participants with Progression to CKF(Over 24 months)
- Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations(Up to Week 112)
- Number of Participants With Adverse Events (AEs)(Up to Week 112)
- Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests(Up to Week 112)
- Number of Participants With Potentially Clinically Significant Changes in Vital Signs(Up to Week 112)
- Number of Participants With Potentially Clinically Significant Changes in Physical Examinations(Up to Week 112)
- Number of Participants With Injection Site Reactions(Up to Week 112)
- Evaluation of serum ADA(Up to Week 112)
研究者
研究点 (454)
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相关资讯
Sibeprenlimab Demonstrates 54% Proteinuria Reduction in Largest Phase 3 IgA Nephropathy Trial- Sibeprenlimab achieved a 54.3% placebo-adjusted reduction in proteinuria at 12 months in the Phase 3 VISIONARY trial, the largest IgA nephropathy study conducted to date.
- The APRIL inhibitor demonstrated favorable safety profile comparable to placebo while significantly reducing key disease biomarkers including galactose-deficient IgA1 and hematuria rates.
- Otsuka Pharmaceutical received FDA Priority Review for sibeprenlimab with a target action date of November 28, 2025, potentially offering the first targeted therapy for this progressive kidney disease.
- Treatment effects remained consistent across patient subgroups, including those on SGLT2 inhibitors, suggesting additional benefit beyond current standard of care.10 months agoOtsuka's Sibeprenlimab Shows Positive Phase 3 Interim Results for IgA Nephropathy- Otsuka Pharmaceutical's sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo.
- The Phase 3 VISIONARY trial met its primary endpoint after nine months of treatment in adults with IgA nephropathy.
- Otsuka plans to discuss the interim results with the FDA, potentially leading to an accelerated regulatory submission for sibeprenlimab.
- Sibeprenlimab targets APRIL, a key factor in the immune pathogenic cascade of IgA nephropathy, offering a potential new therapeutic strategy.last year