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) - 75 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants will provide written informed consent
  2. Ability to comply with the study protocol, in the investigator's judgment
  3. International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis (LN) by renal biopsy performed in the 6 months prior to screening or during screening
  4. Diagnosed with SLE
  5. UPCR = 1 on a 24-hour collection at screening
  6. Receipt of at least one dose of pulse methylprednisolone IV or equivalent for treatment of the current episode of active LN during the 6 months prior to screening
  7. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
  8. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm

  
  

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

• 1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab
  2. Severe renal impairment,
  3. Sclerosis in > 50% of glomeruli on renal biopsy
  4. Presence of rapidly progressive glomerulonephritis
  5. Receiving any of the following therapies
     • Any anti-CD20 therapy such as rituximab, ocrelizumab, or ofatumumab less than 9 months prior to screening or during screening
     • If an anti-CD20 therapy has been received between 9 and 12 months prior to screening, the peripheral CD19+ B-cell count must be > 25 cells/µl
     • Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
     • Any biologic therapy (other than anti-CD20) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening
     • Oral inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening
     • Any live vaccine during the 28 days prior to screening or during screening
  6. Severe, active central nervous system SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
  7. High risk for clinically significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
  8. Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
  9. HIV infection
  10. Tuberculosis (TB) infection
  11. Active infection of any kind, excluding fungal infection of the nail beds
  12. Any major episode of infection that also fulfills any of the following criteria:
      • Requires hospitalization during the 8 weeks prior to screening or during screening
      • Requires treatment with IV antibiotics or anti-infectives during the 8 weeks prior to screening or during screening
      • Requires treatment with oral antibiotics or anti-infectives during the 2 weeks prior to screening or during screening
  13. History of serious recurrent or chronic infection
  14. History of progressive multifocal leukoencephalopathy (PML)
  15. History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
  16. Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening
  17. Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening
  18. Intolerance or contraindication to study therapies