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.
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.
Non-primary membranous nephropathy or other condition affecting the kidney.
eGFR at screening < 45 mL/min/1.73m2 or kidney function not stable .
Uncontrolled hypertension .
Serum albumin level at screening # 25g/l.
Single group
EVER001
DrugA highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
EVER001
DrugA highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
adverse events
clinical laboratory assessments.
vital signs.
physical examination
To evaluate whether EVER001 can modulate proteinuria in pMN.
Percentage change from baseline of 24 hr proteinuria throughout 52 weeks.
To evaluate whether EVER001 can modulate anti-PLA2R autoantibodies in patients with positive baseline levels of these antibodies.
Percentage change from baseline of anti-PLA2R autoantibody level throughout 52 weeks.
To evaluate the clinical response and immunological response in pMN.
To evaluate the clinical response and immunological response in pMN.
Maximum Observed Plasma Concentration (Cmax) of EVER001
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