A randomized treatment open-label dose-blinded parallel group three arm proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Idiopathic Membranous Nephropathy
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants must provide written informed consent before any study assessments are performed
    2. Able to communicate, understand and comply with the requirements of the study
    3. Female or male adult (=18 years) subjects at screening visit with a diagnosis of idiopathic (primary) MN confirmed by renal biopsy within 24 months prior to screening.
    4. Weight of at least 35 kg and body mass index (BMI) of at least 15 kg/m2.
    5. Participants receiving stable dose at the maximum recommended dose according to local guidelines or maximum tolerated dose of ACEi and/or ARB and/or statins and/or diuretics.
    6. Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae
    7. Participants agrees to collect 24h urine sample at home and to bring it to the investigational site at specific visits.

You may not be eligible for this study if the following are true:

    1. Secondary causes of MN, e.g. systemic autoimmune diseases, solid or haematological malignancies, infections or chronic intake of drugs
    2. Diagnostic renal biopsy showing evidence of crescent formation in glomeruli, suggestive of an alternative or additional diagnosis to primary idiopathic MN
    3. Previous treatment with B-cell depleting or B-cell modifying agents such as, but not limited to rituximab, belimumab, daratumomab or bortezomib
    4. Previous treatment with immunosuppressive agents such as cyclophosphamide, chlorambucil, mycophenolate mofetil (or equivalent), cyclosporine, tacrolimus or azathioprine within 90 days prior
    5. Administration of any live vaccination within 4 weeks prior to Day 1
    6. Previous treatment with gemfibrozil or strong CYP2C8 inhibitors such as clopidogrel within 7 days prior to Day 1
    7. Use of other investigational drugs within 30 days
    8. History of malignancy of any organ system (other than localised basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated,
    9. History of clinically significant ECG abnormalities
    10. Presence or suspicion (based on judgment of the investigator) of active infection
    11. Pregnant or lactating
    12. History of immunodeficiency diseases,
    13. History of any porphyria metabolic disorder
    14. History of solid organ or bone marrow transplantation
    15. History of recurrent severe allergic reactions which in the opinion of the investigator deem the subject unsuitable for participation
    16. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
    17. Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV)
    18. Those who have Tuberculosis infection (active or latent) or at risk for Tuberculosis (



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