Clinical Research Studies

Are you eligible to participate in this study?

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

• Conditions:
  Lupus Nephritis
• Age: Between 18 Year(s) - 89 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Has a body mass index of =18 kg/m2.
  2. Has a diagnosis of systemic lupus erythematosus (SLE).
  3. Has a diagnosis of III or IV LN as evidenced by renal biopsy performed within 12 months prior to or during Screening.
  4. Is willing to be treated with mycophenolate mofetil (MMF), or equivalent and corticosteroid therapy.

  
  

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

• 1. Has previously received zetomipzomib or previously enrolled in the study (patients may be rescreened once).
  2. Has had dialysis within the 52 weeks prior to Screening.
  3. Has active central nervous system manifestations resulting from SLE.
  4. Has a history of antiphospholipid syndrome with a history of thromboembolic event within 52 weeks of Screening.
  5. Has a history of unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
  6. Has concomitant chronic conditions (excluding SLE and LN), such as asthma or Crohn’s disease, that required systemic corticosteroid use in the 52 weeks prior to Screening.
  7. Has known intolerance to MMF =1 g/day or equivalent and corticosteroids or inability to take corticosteroids.
  8. Female patients who are pregnant, planning to get pregnant, or nursing during the study.
  9. Has a history of solid organ transplant or planned transplant during the study period.
  10. Has not recovered from a previous surgery or has a planned surgery during study period.
  11. Has a hypersensitivity to the zetomipzomib or placebo or any of its excipients.