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Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
Led by Everest Medicines (China) Co.,Ltd. · Updated on 2025-05-31
30
Participants Needed
19
Research Sites
174 weeks
Total Duration
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AI-Summary
What this Trial Is About
EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases. The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted disease is primary membranous nephropathy.
CONDITIONS
Official Title
Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of primary membranous nephropathy confirmed by biopsy
- Positive anti-PLA2R autoantibody test results greater than 20 relative units (RU)/ml
- At least one proteinuria test above 3.5 g/24h during screening
- Nephrotic range proteinuria for at least 8 weeks prior to Day 1 without improvement despite ACE inhibitor or ARB therapy, unless contraindicated
- For patients with two proteinuria tests above 8.0 g/24h during screening, duration of nephrotic range proteinuria for 8 weeks is not required
You will not qualify if you...
- Non-primary membranous nephropathy or other kidney conditions
- eGFR below 45 mL/min/1.73m2 or unstable kidney function
- Uncontrolled high blood pressure
- Serum albumin level at screening at or below 25 g/l
- Previous B-cell targeted therapies except rituximab at any time
- Rituximab or biosimilars within 2 years unless B-cell repopulation over 90% documented
- Cyclophosphamide or Chlorambucil within 180 days
- Other immunosuppressive or immunomodulatory agents within 90 days
- Prednisone doses over 30 mg/day within 30 days
- Acute or chronic infections, including positive tuberculosis test
- Positive tests for TP, HIV, HBV, or HCV
- Blood test abnormalities including low white blood cells, lymphocytes, neutrophils, hemoglobin, platelet counts, or abnormal clotting times
- Elevated liver enzymes or bilirubin
- Investigator judgment of likely non-compliance with study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 19 locations
1
The Second Xiangya Hospital Of Central South University
Changsha, Changsha, China
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2
The First Affiliated Hospital of PLA Army Medical University
Chongqing, Chongqing Municipality, China
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3
The Third Affiliated Hospital,Sun Yat Sen University
Guangzhou, Guangdong, China
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4
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
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5
The Second Affiliated Hospital of Harbin Medical University
Harbin, Harbin, China
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6
Xiangya Third Hospital, Central South University
Changsha, Hunan, China
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7
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
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8
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
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9
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
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10
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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11
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
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12
The First Affiliated Hospital of Medical college of Xi'an Jiaotong University
Xian, Shanxi, China
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13
Sichuan Province People's Hospital
Chengdu, Sichuan, China
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14
Second Hospital of Shanxi Medical University
Shanxi, Taiyuan, China
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15
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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16
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
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17
The first affliated hospital of NingBo university
Ningbo, Zhejiang, China
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18
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
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19
Peking University First Hospital
Beijing, China
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Research Team
L
Lixia Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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