[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Everest Medicines (China) Co.,Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100640089","phase-2-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ever001-in-participants-with-selected-proteinuric-glomerular-diseases-100640089",false,"NCT07614477","Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases","The Sub-Study 3 of A Phase 1b\u002F2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)","Inclusion Criteria:\n\n* Primary FSGS or MCD\u002FIgAN confirmed by renal biopsy\n* eGFR ≥ 45 mL\u002Fmin\u002F1.73 m²\n* For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) \\> 3.5 g\u002Fg and serum albumin \\\u003C 30 g\u002FL during the screening period\n* For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g\u002Fg; ARB or ACEI stable for ≥ 12 weeks prior to Day 1\n* Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment\n\nExclusion Criteria:\n\n* Hereditary or secondary FSGS\u002FMCD; collapsing FSGS\n* BMI ≥ 35 kg\u002Fm² in participants with FSGS\u002FMCD\n* Evidence of diabetes mellitus or a history of diabetes mellitus\n* Acute or chronic infection requiring treatment\n* Patients infected with HIV, hepatitis C, syphilis, or hepatitis B\n* Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB\n* At risk of bleeding\n* Baseline 24-hour UPCR \\> 3 g\u002Fg and serum albumin \\\u003C 30 g\u002FL in participants with IgAN","ALL","18 Years","75 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 1b\u002F2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at \\~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.",[27,28,29],"Minimal Change Disease (MCD)","IgA Nephropathy (IgAN)","Focal Segmental Glomerulosclerosis (FSGS)","RECRUITING","2026-05-22",{"date":33,"type":34},"2026-05-29","ACTUAL",{"date":36,"type":21},"2026-05-15",{"date":38,"type":21},"2029-03-31",{"name":40,"class":41},"Everest Medicines (China) Co.,Ltd.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100500793","phase-1-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ever001-100500793","NCT05800873","Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001","A Phase 1b\u002F2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases","Inclusion Criteria:\n\n1. Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.\n2. Have positive anti-PLA2R autoantibody test results \\> 20 relative units (RU)\u002Fml.\n3. During screening at least one testing of proteinuria must be \\>3.5 g\u002F24h.\n4. Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\\\u003C50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g\u002F24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.\n\nExclusion Criteria:\n\n1. Non-primary membranous nephropathy or other condition affecting the kidney.\n2. eGFR at screening \\\u003C 45 mL\u002Fmin\u002F1.73m2 or kidney function not stable .\n3. Uncontrolled hypertension .\n4. Serum albumin level at screening # 25g\u002Fl.\n5. 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\u002Fimmunomodulatory agents within 90 days;greater than 30mg\u002Fday prednisone or equivalence within 30 days.\n6. Acute or chronic infection,including positivity of tuberculosis infection test.\n7. Positive serology for TP,HIV, HBV, or HCV.\n8. Lab testing abnormality as: WBC\\\u003C 3000\u002Fmm³, Lymphocyte \\\u003C 1000\u002F mm³, neutrophil \\\u003C1500\u002Fmm³, Hb \\\u003C 80g\u002FL, Platelet count \\\u003C100×10e9\u002F 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.\n9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.",{"count":50,"type":21},30,[52],"PHASE1","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.\n\nThe 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.",[55],"Primary Membranous Nephropathy","2025-05-26",{"date":58,"type":34},"2025-05-31",{"date":60,"type":34},"2023-05-15",{"date":62,"type":21},"2026-09-15",{"name":40,"class":41},19,""]