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 - 75 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants who are willing and able to comply with all the study procedures.
  2. Have a clinical diagnosis of SLE
  3. Have serologically positive SLE
  4. Currently receiving a stable dose of/or have documented failed therapy with one of the following: methotrexate (MTX), azathioprine (AZA), mycophenolate/mycophenolic acid (MMF), anti-malarials (hydroxychloroquine or chloroquine) or corticosteroids (if monotherapy, greater than or equal to 7.5 mg per day)
  5. Have active disease defined as:
     • SLEDAI-2K score of =6 points at screening, and “Clinical” SLEDAI-2K score of =4 points at both screening and randomization
     • BILAG Level A disease in =1 organ system
  6. Participants weighing greater than 35 kg and less than 130 kg
  7. Capable of giving signed informed consent

  
  

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

• 1. Have active renal lupus
  2. Have severe active central nervous system (CNS) lupus
  3. Have cancer or a history of cancer within 5 years of screening
  4. Have a history of a major organ transplant
  5. Have a history of thrombosis
  6. Have acute coronary syndrome
  7. Have pre-existing demyelinating disorder
  8. A history of additional risk factors for torsade de pointes
  9. A participant with any condition possibly affecting oral drug absorption
  10. Have a history of lymphoproliferative disease
  11. 1. Have active fibromyalgia/myofascial/chronic pain that, in the investigator’s opinion, would make it difficult to appropriately assess SLE activity for the purposes of this study
  12. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation