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
- 进行中（未招募）
- 入组人数
- 383
- 试验地点
- 223
- 主要终点
- Change from baseline in eGFR
研究概览
简要总结
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
详细描述
Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301, Novartis FUB523, or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m^2. The exploratory cohort will be randomized using the same schema as the primary cohort.
The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on eGFR as measured by the change from Baseline in eGFR.
Following completion of the 104-week treatment period, subjects may be eligible to enroll in an open-label extension (OLE) study to receive open-label treatment with BION-1301 under a separate protocol. Subjects who do not enroll in the OLE will enter the protocol-specified 24-week safety follow-up period.
To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.
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)
盲法说明
Double-blind
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 participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
- •Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
- •eGFR ≥ 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation.
- •Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
- •Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.
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.
- •Current or history of nephrotic syndrome.
- •Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for > 14 days within 12 weeks prior to Screening.
- •Use of systemic immunosuppressant medications.
- •IgG levels < 6 g/L at Screening.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BION-1301
600mg subcutaneous administration every 2 weeks for 104 weeks
干预措施: BION-1301 (Drug)
Placebo
subcutaneous administration every 2 weeks for 104 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in eGFR
时间窗: Baseline and 104 weeks or approximately 2 years
Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation
次要结局
- Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)(Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104)
- Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)(Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104)
- Percent Change in Proteinuria and Total Urine Protein(40 weeks or approximately 9 months)
- Annualized rate of change in eGFR(104 weeks or approximately 2 years)
- Change in proteinuria (natural log UPCR)(Baseline and 40 weeks or approximately 9 months)