A Phase 2 interventional study of EVER001 in Minimal Change Disease (MCD), IgA Nephropathy (IgAN) and Focal Segmental Glomerulosclerosis (FSGS), sponsored by Everest Medicines (China) Co.,Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Everest Medicines (China) Co.,Ltd. · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Participants in this arm receive EVER001 200 mg administered twice daily (bid) orally. This single-arm cohort evaluates the efficacy and safety of EVER001 in subjects with FSGS, MCD, and IgA
Drug: EVER001
EVER001 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)
Time frame: Week24
Treatment-emergent adverse events (TEAEs)
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)
Time frame: Throughout the study period, up to Week 56
Adverse events of special interest (AESIs)
Incidence of adverse events of special interest (AESIs)
Time frame: Throughout the study period, up to Week 56
Systolic blood pressure change from baseline
Measured in mmHg using a calibrated clinical blood pressure monitor
Time frame: Throughout the study period, up to Week 56
Body weight change from baseline
Measured in kilograms (kg) using a calibrated clinical scale
Time frame: Throughout the study period, up to Week 56
Change from baseline in clinical laboratory safety parameters
Change from baseline in routine clinical laboratory safety parameters, measured using standard validated clinical laboratory assays and reported in standard clinical units
Time frame: Throughout the study period, up to Week 56
Physical examination findings
Incidence of new or worsening abnormalities in physical examination findings, assessed at scheduled study visits.
Time frame: Throughout the study period, up to Week 56
Chest radiography findings
Incidence of new or worsening abnormalities in chest radiography findings, assessed at scheduled study visits.
Time frame: Throughout the study period, up to Week 56
12-lead electrocardiogram (ECG) findings
Incidence of new or worsening abnormalities in 12-lead electrocardiogram (ECG) findings, assessed at scheduled study visits.
Time frame: Throughout the study period, up to Week 56
Pulse rate change from baseline
Measured in beats per minute (bpm) using a calibrated vital signs monitor
Time frame: Throughout the study period, up to Week 56
Diastolic blood pressure change from baseline
Measured in mmHg using a calibrated clinical blood pressure monitor
Time frame: Throughout the study period, up to Week 56
Body temperature change from baseline
Measured in degrees Celsius (°C) using a calibrated clinical thermometer
Time frame: Throughout the study period, up to Week 56
Percentage change from baseline in 24-hour UPCR
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Time frame: Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR)
Proportion of participants achieving complete remission (CR) based on predefined criteria
Time frame: Week 2 and thereafter, up to Week 56
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
Time frame: 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
Time frame: Week 2 and thereafter, up to Week 56
eGFR slope from baseline
Slope of change in estimated glomerular filtration rate (eGFR, calculated per the formula specified in the study protocol) from baseline to Week 52
Time frame: Baseline to Week 52
Percentage change from baseline in serum albumin
Percentage change from baseline in serum albumin level
Time frame: Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR)
Proportion of participants achieving partial remission (PR) based on predefined study criteria
Time frame: Week 2 and thereafter, up to Week 56
Proportion of participants achieving CR or PR
Proportion of participants achieving complete remission (CR) or partial remission (PR) based on predefined study criteria
Time frame: Week 2 and thereafter, up to Week 56
Time to achieve CR or PR
Time from baseline to first documented complete remission (CR) or partial remission (PR), based on predefined study criteria
Time frame: Baseline to Week 52
Proportion of participants with relapse (CR/PR, no rescue therapy)
Proportion of participants who experience relapse among those achieving CR or PR during the study and not receiving rescue therapy
Time frame: From Day1 to Week 52
Time from CR/PR to relapse
Time from first documented complete remission (CR) or partial remission (PR) to first documented relapse
Time frame: From Day1 to Week 52
Cumulative dose of glucocorticoids (GC)
Cumulative dose of glucocorticoids (GC), measured in prednisone equivalent dose, calculated at the specified study visits
Time frame: Week 16, Week 24, Week 32, Week 40, and Week 52
Proportion requiring GC increase or additional immunosuppressants
Proportion of participants requiring increase in GC dosage and/or initiation of additional immunosuppressants
Time frame: Throughout the study period (baseline to Week 56)
Proportion of IgAN participants with positive hematuria
Proportion of participants with IgAN with positive hematuria
Time frame: At baseline, Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in IgAN participants
Resolution of hematuria in participants with IgA
Time frame: At Week 12, Week 24, Week 36, and Week 52
Change from baseline in BTK target occupancy
Change from baseline in BTK target occupancy in peripheral blood cells
Time frame: Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)
Plasma EVER001 peak concentration (Cmax)
Time frame: Throughout the study period, up to Week 56
Trough Plasma Concentration (Cmin) of EVER001
Plasma EVER001 trough concentration (Cmin)
Time frame: Throughout the study period, up to Week 56
Time to Reach Peak Concentration (Tmax) of EVER00
Time to reach peak concentration (Tmax) of EVER001
Time frame: Throughout the study period, up to Week 56
Accumulation Ratio (AR) of EVER001
Accumulation ratio (AR) of EVER001
Time frame: Throughout the study period, up to Week 56
Plan to share: No
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Everest Medicines (China) Co.,Ltd.