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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20260886 | Registry Identifier | A Study to Evaluate the Efficacy and Safety of EVER001 in Patients with Selected Glomerular Diseases |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVER001 200mg bid | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVER001 | Drug | EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Week24 |
| Treatment-emergent adverse events (TEAEs) | Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs) | Throughout the study period, up to Week 56 |
| Adverse events of special interest (AESIs) | Incidence of adverse events of special interest (AESIs) | Throughout the study period, up to Week 56 |
| Systolic blood pressure change from baseline | Measured in mmHg using a calibrated clinical blood pressure monitor | Throughout the study period, up to Week 56 |
| Body weight change from baseline | Measured in kilograms (kg) using a calibrated clinical scale | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in 24-hour UPCR | Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR) | Week 2 and thereafter, up to Week 56 |
| Proportion of participants achieving complete remission (CR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Liao | Contact | +8621- 8012 5712 | fei.liao@everestmedicines.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| 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. | 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. | 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 | Throughout the study period, up to Week 56 |
| Diastolic blood pressure change from baseline | Measured in mmHg using a calibrated clinical blood pressure monitor | Throughout the study period, up to Week 56 |
| Body temperature change from baseline | Measured in degrees Celsius (°C) using a calibrated clinical thermometer | Throughout the study period, up to Week 56 |
Proportion of participants achieving complete remission (CR) based on predefined criteria
| 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 | 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 | 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 | Baseline to Week 52 |
| Percentage change from baseline in serum albumin | Percentage change from baseline in serum albumin level | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Throughout the study period (baseline to Week 56) |
| Proportion of IgAN participants with positive hematuria | Proportion of participants with IgAN with positive hematuria | At baseline, Week 12, Week 24, Week 36, and Week 52 |
| Resolution of hematuria in IgAN participants | Resolution of hematuria in participants with IgA | 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 | Throughout the study period, up to Week 56 |
| Plasma EVER001 peak concentration (Cmax) | Plasma EVER001 peak concentration (Cmax) | Throughout the study period, up to Week 56 |
| Trough Plasma Concentration (Cmin) of EVER001 | Plasma EVER001 trough concentration (Cmin) | Throughout the study period, up to Week 56 |
| Time to Reach Peak Concentration (Tmax) of EVER00 | Time to reach peak concentration (Tmax) of EVER001 | Throughout the study period, up to Week 56 |
| Accumulation Ratio (AR) of EVER001 | Accumulation ratio (AR) of EVER001 | Throughout the study period, up to Week 56 |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Hebei | China |
|
| ID | Term |
|---|---|
| D009402 | Nephrosis, Lipoid |
| D005922 | Glomerulonephritis, IGA |
| D005923 | Glomerulosclerosis, Focal Segmental |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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