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:
  Systemic Lupus Erythematosus
• Age: Between 18 years - 70 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Willing and able to understand and provide written informed consent prior to any studyrelated procedures and to comply with all study requirements and complete study assessments
  2. Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
  3. Disease duration of at least 6 months from the time of diagnosis at the time of signing the ICF
  4. Active SLE
  5. Ongoing treatment for SLE
  6. Women of childbearing potential must have a negative urine pregnancy test and use highly effective contraceptive methods through the end of the study followup or 3 months following the last dose of IP

  
  

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

• 1. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of participant safety or study results
  2. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous mAb or human Ig therapy
  3. Participation in another clinical study with an investigational drug within 4 weeks prior to Day 1 or within 5 published half-lives, whichever is longer
  4. History of drug or alcohol abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits, or interfere with other study assessments
  5. Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393
  6. Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP
  7. Spontaneous or induced abortion, still or live birth, or pregnancy = 4 weeks prior to Screening
  8. Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory, splenectomy, or any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection
  9. Any central laboratory test results outside of acceptable range
  10. Confirmed positive test for hepatitis B serology
  11. Positive test for hepatitis C virus antibody
  12. Confirmed positive test for hepatitis B serology
  13. Positive test for hepatitis C virus antibody
  14. Active TB, or a positive IFN-gamma release assay (IGRA) test
  15. Any severe herpes virus family infection
  16. Any herpes zoster, CMV, or Epstein-Barr virus infection
  17. Any infection requiring hospitalization
  18. History of clinically significant cardiac disease
  19. History of cancer within the past 5 years
  20. Any acute illness or evidence of clinically significant active infection
  21. Receipt of a live-attenuated vaccine within 4 weeks prior to Day 1
  22. Participant should be assessed for epidemiologic risk of COVID-19 (ie, recent exposure, high-risk housing) and for health-related risk of COVID-19 severity based on current understanding of risk factors for severe disease when making a decision regarding the individual’s risk of participation