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
• Age: Between 18 years - 65 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants who will provide written informed consent
  2. Are willing and able to comply with procedures required in this protocol
  3. Clinical diagnosis of SLE at least 24 weeks prior to Screening
  4. Background treatment, stable for 30 days, at Baseline with prednisone (= 20 mg), antimalarials, azathioprine (= 150 mg), mycophenolate (= 2 g), leflunomide (= 20 mg) cyclosporine, tacrolimus, and/or methotrexate (MTX) (= 20 mg)
  5. No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials
  6. Must not be using IV or IM corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization

  
  

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

• 1. Participants with active TB or latent TB without history of appropriate prophylaxis
  2. Participants with human immunodeficiency virus (HIV) and hepatitis B (HB) and C infections
  3. Develops a serious infection or serious opportunistic infection (excludes non-serious oropharyngeal candidiasis) with study treatment
  4. Has active lupus nephritis
  5. Receives hemodialysis
  6. Pregnant or lactating
  7. Have a history of any malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in-situ (CIS)
  8. Have drug or alcohol abuse
  9. Have a history of GI perforation
  10. Must not have history of clinically significant medical conditions or any other reason that in the opinion of the Investigator would interfere with study participation
  11. Have had an active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior to the first dose of study drug
  12. Suspected or confirmed COVID-19 virus