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NCT Number: NCT07614477

Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases

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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Key information

Conditions

Minimal Change Disease (MCD) Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Focal Segmental Glomerulosclerosis (FSGS) Glomerulonephritis Glomerulonephritis, IGA Glomerulosclerosis, Focal Segmental IgA Nephropathy (IgAN) Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Nephrosis Nephrosis, Lipoid Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment

Exclusion criteria

  • 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
  • Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
  • Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
  • At risk of bleeding
  • Baseline 24-hour UPCR > 3 g/g and serum albumin < 30 g/L in participants with IgAN

Treatment and study plan

EVER001

Drug

EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA

Primary outcomes

  1. Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)

    Time frame: Week24

    Percentage change from baseline in 24-hour UPCR (based on 24-hour urine collection)

  2. Treatment-emergent adverse events (TEAEs)

    Time frame: Throughout the study period, up to Week 56

    Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)

  3. Adverse events of special interest (AESIs)

    Time frame: Throughout the study period, up to Week 56

    Incidence of adverse events of special interest (AESIs)

  4. Systolic blood pressure change from baseline

    Time frame: Throughout the study period, up to Week 56

    Measured in mmHg using a calibrated clinical blood pressure monitor

  5. Body weight change from baseline

    Time frame: Throughout the study period, up to Week 56

    Measured in kilograms (kg) using a calibrated clinical scale

  6. Change from baseline in clinical laboratory safety parameters

    Time frame: Throughout the study period, up to Week 56

    Change from baseline in routine clinical laboratory safety parameters, measured using standard validated clinical laboratory assays and reported in standard clinical units

  7. Physical examination findings

    Time frame: Throughout the study period, up to Week 56

    Incidence of new or worsening abnormalities in physical examination findings, assessed at scheduled study visits.

  8. Chest radiography findings

    Time frame: Throughout the study period, up to Week 56

    Incidence of new or worsening abnormalities in chest radiography findings, assessed at scheduled study visits.

  9. 12-lead electrocardiogram (ECG) findings

    Time frame: Throughout the study period, up to Week 56

    Incidence of new or worsening abnormalities in 12-lead electrocardiogram (ECG) findings, assessed at scheduled study visits.

  10. Pulse rate change from baseline

    Time frame: Throughout the study period, up to Week 56

    Measured in beats per minute (bpm) using a calibrated vital signs monitor

  11. Diastolic blood pressure change from baseline

    Time frame: Throughout the study period, up to Week 56

    Measured in mmHg using a calibrated clinical blood pressure monitor

  12. Body temperature change from baseline

    Time frame: Throughout the study period, up to Week 56

    Measured in degrees Celsius (°C) using a calibrated clinical thermometer

Secondary outcomes

  1. Percentage change from baseline in 24-hour UPCR

    Time frame: Week 2 and thereafter, up to Week 56

    Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)

  2. Proportion of participants achieving complete remission (CR)

    Time frame: Week 2 and thereafter, up to Week 56

    Proportion of participants achieving complete remission (CR) based on predefined criteria

  3. Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline

    Time frame: At Week 24, Week 36, and Week 52

    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

  4. Change from baseline in estimated glomerular filtration rate (eGFR)

    Time frame: Week 2 and thereafter, up to Week 56

    Absolute and percentage change from baseline in estimated glomerular filtration rate (eGFR), calculated per the formula specified in the study protocol

  5. eGFR slope from baseline

    Time frame: Baseline to Week 52

    Slope of change in estimated glomerular filtration rate (eGFR, calculated per the formula specified in the study protocol) from baseline to Week 52

  6. Percentage change from baseline in serum albumin

    Time frame: Week 2 and thereafter, up to Week 56

    Percentage change from baseline in serum albumin level

  7. Proportion of participants achieving partial remission (PR)

    Time frame: Week 2 and thereafter, up to Week 56

    Proportion of participants achieving partial remission (PR) based on predefined study criteria

  8. Proportion of participants achieving CR or PR

    Time frame: Week 2 and thereafter, up to Week 56

    Proportion of participants achieving complete remission (CR) or partial remission (PR) based on predefined study criteria

  9. Time to achieve CR or PR

    Time frame: Baseline to Week 52

    Time from baseline to first documented complete remission (CR) or partial remission (PR), based on predefined study criteria

  10. Proportion of participants with relapse (CR/PR, no rescue therapy)

    Time frame: From Day1 to Week 52

    Proportion of participants who experience relapse among those achieving CR or PR during the study and not receiving rescue therapy

  11. Time from CR/PR to relapse

    Time frame: From Day1 to Week 52

    Time from first documented complete remission (CR) or partial remission (PR) to first documented relapse

  12. Cumulative dose of glucocorticoids (GC)

    Time frame: Week 16, Week 24, Week 32, Week 40, and Week 52

    Cumulative dose of glucocorticoids (GC), measured in prednisone equivalent dose, calculated at the specified study visits

  13. Proportion requiring GC increase or additional immunosuppressants

    Time frame: Throughout the study period (baseline to Week 56)

    Proportion of participants requiring increase in GC dosage and/or initiation of additional immunosuppressants

  14. Proportion of IgAN participants with positive hematuria

    Time frame: At baseline, Week 12, Week 24, Week 36, and Week 52

    Proportion of participants with IgAN with positive hematuria

  15. Resolution of hematuria in IgAN participants

    Time frame: At Week 12, Week 24, Week 36, and Week 52

    Resolution of hematuria in participants with IgA

  16. Change from baseline in BTK target occupancy

    Time frame: Throughout the study period, up to Week 56

    Change from baseline in BTK target occupancy in peripheral blood cells

  17. Plasma EVER001 peak concentration (Cmax)

    Time frame: Throughout the study period, up to Week 56

    Plasma EVER001 peak concentration (Cmax)

  18. Trough Plasma Concentration (Cmin) of EVER001

    Time frame: Throughout the study period, up to Week 56

    Plasma EVER001 trough concentration (Cmin)

  19. Time to Reach Peak Concentration (Tmax) of EVER00

    Time frame: Throughout the study period, up to Week 56

    Time to reach peak concentration (Tmax) of EVER001

  20. Accumulation Ratio (AR) of EVER001

    Time frame: Throughout the study period, up to Week 56

    Accumulation ratio (AR) of EVER001

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Liao

CONTACT

[email protected]

+8621- 8012 5712

Sponsors and collaborators

Lead sponsor

Everest Medicines (China) Co.,Ltd.

Industry

Registry information

Official study title

The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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