Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
NCT ID: NCT05800873
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2023-05-15
2026-09-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EVER001 100mg
EVER001 100mg QD for 4 weeks, followed by EVER001 100mg BID for 32 weeks.
EVER001
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
EVER001 200mg
EVER001 200mg BID for 36 weeks.
EVER001
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
Interventions
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EVER001
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
EVER001
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
Eligibility Criteria
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Inclusion Criteria
2. Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
3. During screening at least one testing of proteinuria must be \>3.5 g/24h.
4. Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.
Exclusion Criteria
2. eGFR at screening \< 45 mL/min/1.73m2 or kidney function not stable .
3. Uncontrolled hypertension .
4. Serum albumin level at screening # 25g/l.
5. Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to \>90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
6. Acute or chronic infection,including positivity of tuberculosis infection test.
7. Positive serology for TP,HIV, HBV, or HCV.
8. Lab testing abnormality as: WBC\< 3000/mm³, Lymphocyte \< 1000/ mm³, neutrophil \<1500/mm³, Hb \< 80g/L, Platelet count \<100×10e9/ L, Prothrombin time\>1.5×ULN, Activated partial thromboplastin time ≥1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin \>1.5×ULN.
9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
18 Years
75 Years
ALL
No
Sponsors
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Everest Medicines (China) Co.,Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Xiangya Hospital Of Central South University
Changsha, Changsha, China
The First Affiliated Hospital of PLA Army Medical University
Chongqing, Chongqing Municipality, China
The Third Affiliated Hospital,Sun Yat Sen University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Harbin, China
Xiangya Third Hospital, Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Medical college of Xi'an Jiaotong University
Xian, Shanxi, China
Sichuan Province People's Hospital
Chengdu, Sichuan, China
Second Hospital of Shanxi Medical University
Shanxi, Taiyuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The first affliated hospital of NingBo university
Ningbo, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Peking University First Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Liu Hong
Role: primary
Zhao Hong Wen
Role: primary
Peng Hui
Role: primary
Xiong Zu Ying
Role: primary
Du Xuan Yi
Role: primary
Zhang Hao
Role: primary
Wang Cai Li
Role: primary
Liu Bi Cheng
Role: primary
Zeng Ying
Role: primary
Xu Cheng Yun
Role: primary
Zhang Wen
Role: primary
Lu Wan Hong
Role: primary
Chen Xiu Ling
Role: primary
Wang Li Hua
Role: primary
Ma Kun Ling
Role: primary
Li Yi Wen
Role: primary
Huang Jian Cheng
Role: primary
Xu Guang Biao
Role: primary
Minghui Zhao
Role: primary
Other Identifiers
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ES108001
Identifier Type: -
Identifier Source: org_study_id
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