Syneos Health - Phase 1b/2 Study of KZR-616-002 in Patients with Systemic Lupus Erythematosus with and without Nephritis

Are you eligible to participate in this study?

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

  • Conditions:
    Lupus Erythematosus
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male or female patients aged 18 to 75 years (inclusive)
    2. Body mass index (BMI) great than or equal to 18 kg/m2
    3. Fulfills the 2012 SLICC classification criteria for SLE
    4. Have at least one of the following at screening per central lab:
      • Positive antinuclear antibody (ANA) test; or
      • Anti-double stranded deoxyribonucleic acid (dsDNA) antibodies elevated to above normal; or
      • Anti-Smith antibody elevated to above normal
    5. Active SLE
    6. Currently receiving one or more immunosuppressive agents that has been stable for dose and route of administration for = 8 weeks prior to Baseline.
    7. Acceptable screening laboratory values of concern as per the protocol
    8. Renal biopsy within 2 years of the Screening visit with a histologic diagnosis of LN
    9. Acceptable screening laboratory values
    10. Women of childbearing potential must have negative pregnancy test and agree to use highly effective method of birth control
    11. Male participants must use an effective contraception method
    12. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements

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

    1. Any of the following:
      • Dialysis within 12 months prior to Screening
      • Rapidly progressive glomerulonephritis (RPGN) and/or renal disease
      • Chronic kidney disease not due to LN
      • > 50% sclerosed glomeruli on most recent renal biopsy
    2. Presence of another rheumatic (overlap) disease that may confound clinical assessments in the study
    3. History of antiphospholipid syndrome with thromboembolic event within 12 months of screening or not on an adequate anticoagulation regimen.
    4. Active central nervous system involvement by autoimmune disease
    5. Active or chronic infecton:
      • Acute or chronic bacterial or fungal infections
      • Acute viral illness
      • Chronic viral infection
    6. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases
    7. QT interval with Fridericia’s correction (QTcF) or Bazett’s correction (QTcB)> 480 msec on ECG
    8. Major surgery within 12 weeks before signing the ICF or major surgery planned during the study period
    9. Any active or suspected malignancy or history of documented malignancy
    10. Hypersensitivity to the Investigational Medicinal Products or any of its excipients.



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