This is a Phase 1b/2, 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.
Primary FSGS or MCD/IgAN confirmed by renal biopsy
eGFR ≥ 45 mL/min/1.73 m²
For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) > 3.5 g/g and serum albumin < 30 g/L during the screening period
For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
Hereditary or secondary FSGS/MCD; collapsing FSGS
BMI ≥ 35 kg/m² in participants with FSGS/MCD
Evidence of diabetes mellitus or a history of diabetes mellitus
Acute or chronic infection requiring treatment
Single group
EVER001
DrugEVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Percentage change from baseline in 24-hour UPCR (based on 24-hour urine collection)
Treatment-emergent adverse events (TEAEs)
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)
Adverse events of special interest (AESIs)
Incidence of adverse events of special interest (AESIs)
Systolic blood pressure change from baseline
Measured in mmHg using a calibrated clinical blood pressure monitor
Percentage change from baseline in 24-hour UPCR
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Proportion of participants achieving complete remission (CR)
Proportion of participants achieving complete remission (CR) based on predefined criteria
Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline
Proportion of participants with IgAN achieving ≥30% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) from baseline, assessed at Week 24, Week 36, and Week 52
Change from baseline in estimated glomerular filtration rate (eGFR)
Absolute and percentage change from baseline in estimated glomerular filtration rate (eGFR), calculated per the formula specified in the study protocol
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