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Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases

2026年8月3日更新者：Everest Medicines (China) Co.,Ltd.

The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)

This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at ~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.

研究概览

地位

招聘中

条件

干预/治疗

药品：EVER001

研究类型

介入性

注册 (估计的)

阶段

阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Everest Clinical Trial Information Center
电话号码：+86 21 8012 5712
邮箱：ctinfo.center@everestmedicines.com

学习地点

中国
- Beijing Municipality
  - Beijing、Beijing Municipality、中国、100730
    - 招聘中
    - Peking University First Hospital
    - 接触：
      
      Hong Zhang
      
      电话号码：+8610-83575530
      
      邮箱：hongzh@bjmu.edu.cn
- Hebei
  - Tianjin、Hebei、中国
    - 招聘中
    - Tianjin Medical University General Hospital
    - 接触：
      
      yan jun Jia
      
      电话号码：+86-13821735536
      
      邮箱：jiajunya@126.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Primary FSGS or MCD/IgAN confirmed by renal biopsy
eGFR ≥ 45 mL/min/1.73 m²
For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) > 3.5 g/g and serum albumin < 30 g/L during the screening period
For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment

Exclusion Criteria:

Hereditary or secondary FSGS/MCD; collapsing FSGS
BMI ≥ 35 kg/m² in participants with FSGS/MCD
Evidence of diabetes mellitus or a history of diabetes mellitus
Acute or chronic infection requiring treatment
Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
At risk of bleeding
Baseline 24-hour UPCR > 3 g/g and serum albumin < 30 g/L in participants with IgAN

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：EVER001 200mg bid Participants in this arm receive EVER001 200 mg administered twice daily (bid) orally. This single-arm cohort evaluates the efficacy and safety of EVER001 in subjects with FSGS, MCD, and IgA	药品：EVER001 EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR) 大体时间：Week24	Percentage change from baseline in 24-hour UPCR (based on 24-hour urine collection)	Week24
Treatment-emergent adverse events (TEAEs) 大体时间：Throughout the study period, up to Week 56	Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)	Throughout the study period, up to Week 56
Adverse events of special interest (AESIs) 大体时间：Throughout the study period, up to Week 56	Incidence of adverse events of special interest (AESIs)	Throughout the study period, up to Week 56
Systolic blood pressure change from baseline 大体时间：Throughout the study period, up to Week 56	Measured in mmHg using a calibrated clinical blood pressure monitor	Throughout the study period, up to Week 56
Body weight change from baseline 大体时间：Throughout the study period, up to Week 56	Measured in kilograms (kg) using a calibrated clinical scale	Throughout the study period, up to Week 56
Change from baseline in clinical laboratory safety parameters 大体时间：Throughout the study period, up to Week 56	Change from baseline in routine clinical laboratory safety parameters, measured using standard validated clinical laboratory assays and reported in standard clinical units	Throughout the study period, up to Week 56
Physical examination findings 大体时间：Throughout the study period, up to Week 56	Incidence of new or worsening abnormalities in physical examination findings, assessed at scheduled study visits.	Throughout the study period, up to Week 56
Chest radiography findings 大体时间：Throughout the study period, up to Week 56	Incidence of new or worsening abnormalities in chest radiography findings, assessed at scheduled study visits.	Throughout the study period, up to Week 56
12-lead electrocardiogram (ECG) findings 大体时间：Throughout the study period, up to Week 56	Incidence of new or worsening abnormalities in 12-lead electrocardiogram (ECG) findings, assessed at scheduled study visits.	Throughout the study period, up to Week 56
Pulse rate change from baseline 大体时间：Throughout the study period, up to Week 56	Measured in beats per minute (bpm) using a calibrated vital signs monitor	Throughout the study period, up to Week 56
Diastolic blood pressure change from baseline 大体时间：Throughout the study period, up to Week 56	Measured in mmHg using a calibrated clinical blood pressure monitor	Throughout the study period, up to Week 56
Body temperature change from baseline 大体时间：Throughout the study period, up to Week 56	Measured in degrees Celsius (°C) using a calibrated clinical thermometer	Throughout the study period, up to Week 56

次要结果测量

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Everest Medicines (China) Co.,Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月20日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年3月31日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年4月1日

结果测量	措施说明	大体时间
Percentage change from baseline in 24-hour UPCR 大体时间：Week 2 and thereafter, up to Week 56	Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)	Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR) 大体时间：Week 2 and thereafter, up to Week 56	Proportion of participants achieving complete remission (CR) based on predefined criteria	Week 2 and thereafter, up to Week 56
Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline 大体时间：At Week 24, Week 36, and Week 52	Proportion of participants with IgAN achieving ≥30% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) from baseline, assessed at Week 24, Week 36, and Week 52	At Week 24, Week 36, and Week 52
Change from baseline in estimated glomerular filtration rate (eGFR) 大体时间：Week 2 and thereafter, up to Week 56	Absolute and percentage change from baseline in estimated glomerular filtration rate (eGFR), calculated per the formula specified in the study protocol	Week 2 and thereafter, up to Week 56
eGFR slope from baseline 大体时间：Baseline to Week 52	Slope of change in estimated glomerular filtration rate (eGFR, calculated per the formula specified in the study protocol) from baseline to Week 52	Baseline to Week 52
Percentage change from baseline in serum albumin 大体时间：Week 2 and thereafter, up to Week 56	Percentage change from baseline in serum albumin level	Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR) 大体时间：Week 2 and thereafter, up to Week 56	Proportion of participants achieving partial remission (PR) based on predefined study criteria	Week 2 and thereafter, up to Week 56
Proportion of participants achieving CR or PR 大体时间：Week 2 and thereafter, up to Week 56	Proportion of participants achieving complete remission (CR) or partial remission (PR) based on predefined study criteria	Week 2 and thereafter, up to Week 56
Time to achieve CR or PR 大体时间：Baseline to Week 52	Time from baseline to first documented complete remission (CR) or partial remission (PR), based on predefined study criteria	Baseline to Week 52
Proportion of participants with relapse (CR/PR, no rescue therapy) 大体时间：From Day1 to Week 52	Proportion of participants who experience relapse among those achieving CR or PR during the study and not receiving rescue therapy	From Day1 to Week 52
Time from CR/PR to relapse 大体时间：From Day1 to Week 52	Time from first documented complete remission (CR) or partial remission (PR) to first documented relapse	From Day1 to Week 52
Cumulative dose of glucocorticoids (GC) 大体时间：Week 16, Week 24, Week 32, Week 40, and Week 52	Cumulative dose of glucocorticoids (GC), measured in prednisone equivalent dose, calculated at the specified study visits	Week 16, Week 24, Week 32, Week 40, and Week 52
Proportion requiring GC increase or additional immunosuppressants 大体时间：Throughout the study period (baseline to Week 56)	Proportion of participants requiring increase in GC dosage and/or initiation of additional immunosuppressants	Throughout the study period (baseline to Week 56)
Proportion of IgAN participants with positive hematuria 大体时间：At baseline, Week 12, Week 24, Week 36, and Week 52	Proportion of participants with IgAN with positive hematuria	At baseline, Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in IgAN participants 大体时间：At Week 12, Week 24, Week 36, and Week 52	Resolution of hematuria in participants with IgA	At Week 12, Week 24, Week 36, and Week 52
Change from baseline in BTK target occupancy 大体时间：Throughout the study period, up to Week 56	Change from baseline in BTK target occupancy in peripheral blood cells	Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax) 大体时间：Throughout the study period, up to Week 56	Plasma EVER001 peak concentration (Cmax)	Throughout the study period, up to Week 56
Trough Plasma Concentration (Cmin) of EVER001 大体时间：Throughout the study period, up to Week 56	Plasma EVER001 trough concentration (Cmin)	Throughout the study period, up to Week 56
Time to Reach Peak Concentration (Tmax) of EVER00 大体时间：Throughout the study period, up to Week 56	Time to reach peak concentration (Tmax) of EVER001	Throughout the study period, up to Week 56
Accumulation Ratio (AR) of EVER001 大体时间：Throughout the study period, up to Week 56	Accumulation ratio (AR) of EVER001	Throughout the study period, up to Week 56

Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases

The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

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