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NCT Number: NCT05800873

Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001

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.

The 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Xiangya Hospital Of Central South University, Changsha, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
  • Have positive anti-PLA2R autoantibody test results > 20 relative units (RU)/ml.
  • During screening at least one testing of proteinuria must be >3.5 g/24h.
  • Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.

Exclusion criteria

  • Non-primary membranous nephropathy or other condition affecting the kidney.
  • eGFR at screening < 45 mL/min/1.73m2 or kidney function not stable .
  • Uncontrolled hypertension .
  • Serum albumin level at screening # 25g/l.
  • 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/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
  • Acute or chronic infection,including positivity of tuberculosis infection test.
  • Positive serology for TP,HIV, HBV, or HCV.
  • Lab testing abnormality as: WBC< 3000/mm³, Lymphocyte < 1000/ mm³, neutrophil <1500/mm³, Hb < 80g/L, Platelet count <100×10e9/ 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.
  • Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

Treatment and study plan

EVER001

Drug

A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.

Primary outcomes

  1. adverse events

    Time frame: 104 weeks.

  2. clinical laboratory assessments.

    Time frame: 104 weeks.

  3. vital signs.

    Time frame: 104 weeks.

  4. physical examination

    Time frame: 104 weeks

  5. ECG.

    Time frame: 104 weeks.

Secondary outcomes

  1. To evaluate whether EVER001 can modulate proteinuria in pMN.

    Time frame: 52 weeks.

    Percentage change from baseline of 24 hr proteinuria throughout 52 weeks.

  2. To evaluate whether EVER001 can modulate anti-PLA2R autoantibodies in patients with positive baseline levels of these antibodies.

    Time frame: 52 weeks.

    Percentage change from baseline of anti-PLA2R autoantibody level throughout 52 weeks.

  3. To evaluate the clinical response and immunological response in pMN.

    Time frame: 104 weeks.

    To evaluate the clinical response and immunological response in pMN.

  4. Maximum Observed Plasma Concentration (Cmax) of EVER001

    Time frame: 52 weeks.

  5. Minimum Observed Plasma Concentration (Cmin) of EVER001

    Time frame: 52 weeks.

  6. Time to Reach Maximum Observed Concentration (Tmax) of EVER001.

    Time frame: 52 weeks.

Study contacts

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

Lixia Wang

CONTACT

[email protected]

00862180123250

Sponsors and collaborators

Lead sponsor

Everest Medicines (China) Co.,Ltd.

Industry

Registry information

Official study title

A Phase 1b/2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2023
Registry last updated
May 31, 2025

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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