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A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants with Selected Proteinuric Glomerular Diseases
Led by Everest Medicines (China) Co.,Ltd. · Updated on 2025-05-31
30
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying EVER001, a highly selective oral drug that targets Bruton tyrosine kinase, to treat proteinuric glomerular diseases, focusing first on primary membranous nephropathy. The study aims to evaluate how effective and safe EVER001 is, along with its behavior in the body, such as how it is absorbed and processed. This is a Phase 1b/2 clinical trial sponsored by Everest Medicines (China) Co., Ltd. Participants will receive EVER001 in two possible dosing schedules: one group takes 100mg once daily for 4 weeks, then 100mg twice daily for 32 weeks, while the other group receives 200mg twice daily for 36 weeks. These treatment periods are designed to assess different dosing effects on the disease. The study is not randomized or blinded, meaning all participants know the treatment they receive. During the study, participants will be monitored for up to 104 weeks to track safety through physical exams, vital signs, ECGs, and lab tests. Researchers will also study how EVER001 affects proteinuria and specific antibodies related to the disease over 52 weeks. The trial includes ongoing assessments of clinical and immune responses, as well as blood levels of the drug to understand its pharmacokinetics. Overall, participants can expect regular visits and evaluations throughout the two-year period.
CONDITIONS
Brief 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 result greater than 20 relative units (RU)/ml
- Proteinuria greater than 3.5 g/24h during screening
- Nephrotic range proteinuria for at least 8 weeks prior to Day 1 with less than 50% improvement despite ACE inhibitor or ARB supportive therapy, except if two proteinuria tests during screening are at least 8.0 g/24h
- Age between 18 and 75 years
You will not qualify if you...
- Non-primary membranous nephropathy or other kidney conditions
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m2 or unstable kidney function
- Uncontrolled high blood pressure
- Serum albumin level at or below 25 g/l at screening
- Prior B-cell targeted therapy except rituximab at any time; rituximab or biosimilars within 2 years unless B-cell repopulation documented
- Use of cyclophosphamide or chlorambucil within 180 days
- Use of other immunosuppressive agents within 90 days
- Use of prednisone greater than 30 mg/day within 30 days
- Acute or chronic infections including positive tuberculosis test
- Positive tests for TP, HIV, HBV, or HCV
- Blood abnormalities such as low white blood cells, lymphocytes, neutrophils, hemoglobin, or platelets; abnormal coagulation or liver enzymes
- Likely inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks depending on dosing regimen
Participants receive EVER001 drug treatment to evaluate its efficacy and safety for proteinuric glomerular diseases.
Regular visits during treatment period
Duration - Up to 68 weeks following treatment
Participants are monitored for safety and clinical response after completing treatment with EVER001.
Visits over 104 weeks total study duration
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
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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