Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
A Phase 1b/2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases
Everest Medicines (China) Co.,Ltd.
30 participants
May 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
Exclusion Criteria9
- 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.
- 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.
- Acute or chronic infection,including positivity of tuberculosis infection test.
- Positive serology for TP,HIV, HBV, or HCV.
- 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.
- Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
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Interventions
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
Locations(19)
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NCT05800873