A Phase 1b/2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
• Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
• During screening at least one testing of proteinuria must be \>3.5 g/24h.
• 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.
Locations
Other Locations
China
The First Affiliated Hospital of Baotou Medical College
RECRUITING
Baotou
Peking University First Hospital
RECRUITING
Beijing
The Second Xiangya Hospital Of Central South University
RECRUITING
Changsha
Xiangya Third Hospital, Central South University
RECRUITING
Changsha
Sichuan Province People's Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of PLA Army Medical University
RECRUITING
Chongqing
The Third Affiliated Hospital,Sun Yat Sen University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The first affliated hospital of NingBo university
RECRUITING
Ningbo
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Second Hospital of Shanxi Medical University
RECRUITING
Shanxi
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
The First Affiliated Hospital of Medical college of Xi'an Jiaotong University
RECRUITING
Xian
Contact Information
Primary
Lixia Wang
lixia.wang@everestmedicines.com
00862180123250
Time Frame
Start Date:2023-05-15
Estimated Completion Date:2026-09-15
Participants
Target number of participants:30
Treatments
Experimental: EVER001 100mg
EVER001 100mg QD for 4 weeks, followed by EVER001 100mg BID for 32 weeks.