CTRI/2024/04/065305尚未招募3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy (The BEYOND Study)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 292
- 试验地点
- 12
- 主要终点
- To evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy
研究概览
简要总结
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy.
Approximately 272 patients with eGFR greater than or equal to 30 mL/min/1.73m2 and with biopsy-proven IgAN will be randomized to receive 600mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 subjects (10 subjects per arm) with biopsy-confirmed IgAN and eGFR of greater than or equal to 20 to less than 30 mL/min/1.73 m2.
The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy.
Subjects will have assessments of safety and efficacy for 2.5 years (up to 134 weeks). To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged more than or equal to 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
- •Biopsy-proven IgAN within the past 10 years that is not due to secondary causes.
- •A pseudonymized copy of the report must be available for review.
- •If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Medical Monitor.
- •eGFR greater than or equal to 30 mL/min/1.73m2 at Screening based on the 2021 CKD-EPI equation (for the exploratory cohort only: eGFR of greater than or equal to 20 to less than 30 mL/min/1.73 m2).
- •Total urine protein greater than or equal to 1.0 g/day and UPCR greater than or equal to 0.7 g/g, as measured from an adequate 24hour urine collection at Screening by a central laboratory.
- •Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to Screening or intolerant to ACEi/ARB; may also be on a stable and well tolerated dose of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the treatment of IgAN.
- •Body mass index (BMI) between 18 and 40 kg/m
- •Screening weight of at least 50 kg.
- •Men and women of childbearing potential must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives after the final dose of study drug.
- •Provide written informed consent and be willing to comply with study visits and procedures.
排除标准
- •Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
- •Diagnosis of IgA Vasculitis or current or history of nephrotic syndrome
- •Average blood pressure (BP) greater than 150/90 mm Hg (systolic/diastolic).
- •Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines (KDIGO, 2021)
- •Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.
- •History of Type 1 Diabetes.
- •o Evidence of diabetic changes on kidney biopsy, performed for any reason.
- •o History of diabetic microvascular/macrovascular disease.
- •Unstable anti-diabetic regimen
- •Prior exposure to any antibody directed against APRIL.
- •History of a previous severe allergic reaction including a history of severe hypersensitivity reaction to any monoclonal antibody.
- •Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.
- •Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for more than 14 days within 12 weeks prior to Screening.
- •Use of systemic immunosuppressant medications
- •Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.
- •Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.
- •Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
- •Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.
结局指标
主要结局
To evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy
时间窗: Change in proteinuria (UPCR) from Baseline to Week 40.
次要结局
- To evaluate the effect of BION-1301 versus placebo on eGFR(Change from Baseline to Week 104 in eGFR.)
- To evaluate the effect of BION-1301 versus placebo on specific clinical composite endpoints during the study(Percent of subjects meeting the composite endpoint of experiencing at least 1 of the following during the study:)
研究者
Rashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
研究点 (12)
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