NCT07157787招募中2 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1920 in Adult Participants With PMN (Primary Membranous Nephropathy) Who Are at a High Risk for Disease Progression
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 41
- 主要终点
- Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (> 20 RU/mL) at Screening, which must be confirmed by a central laboratory
- •Participants are willing to receive the background Standard of Care (SoC)
- •Participants at high risk for disease progression, defined as:
- •Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.
- •Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure < 140 mmHg in ≥ 75% of the readings within last 8 weeks.
- •Having two proteinuria measurements with each > 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
- •eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula
- •All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
排除标准
- •Documented rapid deterioration of kidney function
- •History of life-threatening Nephrotic Syndrome within 1 year before Screening
- •Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R < 20 RU/mL or kidney disease other than PMN
- •History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
- •History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period
- •History or presence of any clinically relevant co-morbidities
- •History of intolerance or hypersensitivity to ACEi or ARB
- •Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization or planned adjustment of GSLT2i dose throughout the treatment period.
- •Use of traditional Chinese medicines or Chinese proprietary medicines with systemic immunosuppressive properties within 6 months prior to screening.
- •Use of MRA, or ERA within 12 weeks prior to randomization and throughout the study period
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Placebo
Experimental
Participants will receive placebo subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.
干预措施: Placebo (Drug)
ALXN1920
Experimental
Participants will receive ALXN1920 subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.
干预措施: ALXN1920 (Drug)
结局指标
主要结局
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26
时间窗: Baseline, Week 26
次要结局
- Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12(Baseline and week 12)
- Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26(Baseline, Week 12 and Week 26)
- Change From Baseline in Serum Albumin at Week 12 and week 26(Baseline, week 12 and Week 26)
- Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26(Baseline, week 12 and week 26)
- Change From Baseline in Peripheral CD19+ B Cell Count at Week 4, Week 8, Week 12 and Week 26(Baseline, Weeks 4, 8, 12 and 26)
- Change From Baseline biomarker level at Week 12 and 26(Baseline and Weeks 12 and 26)
- Change From Baseline in Proteinuria Based on 24-hour UPCR(Baseline)
- Change From Baseline in Proteinuria Based on Spot UPCR at Week 26(Baseline and Week 26)
- Change From Baseline in Serum Albumin at Week 26(Baseline and Week 26)
- Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 26(Baseline and 26)
- Change From Baseline in Peripheral Cluster of Differentiation 20 (CD20+) B Cell Count at Week 4, Week 8, and Week 26(Baseline, Weeks 4, 8 and 26)
- Change From Baseline biomarker level at Week 26(Baseline and Week 26)
研究者
研究点 (41)
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