NCT04716231进行中（未招募）3 期
A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)
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
- 376
- 试验地点
- 1
- 主要终点
- Change from baseline in urine protein to creatinine ratio (UPCR)
研究概览
简要总结
A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)
详细描述
This is a multi-part study comprising of the original Phase 2b study and the addition of a separate pivotal Phase 3 study.
After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with IgAN and persistent proteinuria despite being on a maximally tolerated dose (MTD) of a RASi. Safety, eGFR, serum immunoglobulins and Gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. The UPCR primary endpoint will be assessed after the first 200 patients are randomized.
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
- •Must have the ability to understand and sign a written informed consent form
- •Male or female of ≥18 years of age
- •Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
- •Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
- •eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening
- •Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg
排除标准
- •IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis
- •Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period
- •Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)
- •Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg
- •Renal or other organ transplantation prior to, or expected during the study
- •Concomitant chronic renal disease in addition to IgAN
- •Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
- •History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test
- •Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept
研究组 & 干预措施
Atacicept Dose 150mg
Experimental
Atacicept 150mg once weekly subcutaneous (SC) injections
干预措施: Atacicept (Biological)
Placebo to match Atacicept (Part C/D)
Placebo Comparator
Placebo to match Atacicept once weekly subcutaneous (SC) injection
干预措施: Placebo to match Atacicept (Other)
结局指标
主要结局
Change from baseline in urine protein to creatinine ratio (UPCR)
时间窗: 36 Weeks
UPCR based on 24 hour urine collection
次要结局
- Annualized rate of change in estimated glomerular filtration rate (eGFR)(52 and 104 Weeks)
研究者
研究点 (1)
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相关资讯
Vera Therapeutics' Atacicept Shows Sustained Kidney Function Stabilization in IgAN Patients- Vera Therapeutics announced 96-week data from its ORIGIN Phase 2b trial of atacicept, demonstrating stabilized kidney function in IgA nephropathy (IgAN) patients.
- The study showed a 66% reduction in Gd-IgA1, 75% resolution of hematuria, and a 52% reduction in proteinuria, indicating significant disease modification.
- Atacicept maintained a favorable safety profile with a 90% completion rate, positioning it as a potential first-in-class therapy for IgAN.
- Topline results from the Phase 3 ORIGIN 3 trial are expected in Q2 2025, with a planned BLA submission to the FDA later that year.last yearAtacicept Shows Sustained eGFR Stabilization in IgAN Patients at 96 Weeks in Phase 2b ORIGIN Trial- Vera Therapeutics' atacicept demonstrated stabilization of kidney function in IgAN patients over 96 weeks in the ORIGIN Phase 2b trial.
- The study showed significant reductions in Gd-IgA1, hematuria, and proteinuria, suggesting disease modification potential.
- Topline results from the Phase 3 ORIGIN 3 trial are expected in Q2 2025, with a planned BLA submission to the FDA later in the year.last yearVera Therapeutics Completes Enrollment for Atacicept Phase 3 ORIGIN 3 Trial in IgAN- Vera Therapeutics has completed enrollment for the primary endpoint in its pivotal Phase 3 ORIGIN 3 trial of atacicept for IgAN patients.
- The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating atacicept's safety and efficacy.
- Topline data from the ORIGIN 3 trial, which enrolled 200 participants, is expected in Q2 2025, supporting regulatory submission.
- Vera anticipates presenting 96-week data from the ORIGIN Phase 2b clinical trial of atacicept in IgAN in Q4 2024.2 years ago