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. Body weight = 40 kg at Screening
  2. Female participants of childbearing potential, male participants, and male participants with female partners of childbearing potential must follow protocol specified contraception guidance
  3. Must provide written informed consent
  4. All participants must be vaccinated against meningococcal infection
  5. All participants must also receive vaccinations for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae prior to randomization,

  LN Cohort:

  1. Clinical diagnosis of SLE
  2. Clinically active LN at Screening

  
  

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

• 1. Estimated GFR < 30 mL/min/1.73 m2 during Screening
  2. More than or equal to 50% interstitial fibrosis, tubular atrophy, glomerular sclerosis, or crescent formation in glomeruli on most recent kidney biopsy prior or during the Screening Period
  3. Concomitant significant renal disease
  4. History of kidney transplant or planned kidney transplant
  5. History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant
  6. Splenectomy or functional asplenia
  7. Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant’s full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study
  8. Known or suspected history of drug or alcohol abuse or dependence
  9. History of malignancy
  10. Known history of hepatitis B or C viral infection or HIV infection
  11. Bone marrow insufficiency
  12. Active systemic bacterial, viral, or fungal infection
  13. History of N meningitidis infection
  14. Inability to take or tolerate the standard of care background therapies
  15. Participating in other investigational drug or device studies
  16. Pregnant or breastfeeding or planning to conceive during the study participation

  LN Cohort:

  1. Clinically active SLE-related cerebritis, seizures, pericarditis, stroke, or stroke syndrome requiring treatment
  2. Uncontrolled hypertension
  3. Participants who received treatments after their qualifying kidney biopsy using any of the following: Cyclophosphamide or Calcineurin inhibitors as well as certain doses of IV methylprednisolone, Mycophenolate mofetil or Oral corticosteroids