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
  Immunoglobulin A Nephropathy
• Age: Between 18 Year(s) - 75 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  Inclusion Criteria for All
  1. Participant must be =18 and =75 years of age at the time of signing the informed consent.
  2. Male or female participant.
  3. Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
  4. Vaccinated against meningococcal infection within 3 years.

  Inclusion Criteria for Lupus Nephritis Patients (LN Cohort)
  1. Clinical diagnosis of systemic lupus erythematosus.
  2. Diagnosis of Lupus nephritis Class III or IV; confirmed by biopsy obtained within 6 months. Participants may co-exhibit Class V disease. Participants with de novo or relapsing disease may be eligible.
  3. Clinically active Lupus Nephritis requiring/receiving immunosuppression induction treatment.

  Inclusion Criteria for Immunoglobulin A Nephropathy Patients (IgAN Cohort)
  1. Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the study screening period.
  2. Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated ACE inhibitor and/or ARB dose for ≥ 3 months prior to Screening with no expected change in dose during the study (participants with established intolerance to RAS inhibitors may be included).
  3. Controlled and stable blood pressure (defined as < 140/90 mmHg) over the past 3 months prior to randomization.

  
  

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

• Exclusion Criteria for All
  1. Estimated GFR < 30 mL/min/1.73 m2 during Screening (measure of kidney function).
  2. Significant renal disease other than LN or IgAN.
  3. History of solid organ (kidney, heart, lung, small bowel, pancreas, or liver) or bone marrow transplant, or planned transplant.
  4. Splenectomy or functional asplenia.
  5. History of seizure.
  6. Hemoglobin A1c >7.0 mg/dl.
  7. Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period.
  8. History of cancerous malignancy within 5 years prior to Screening with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
  9. Evidence of hepatitis B or hepatitis C viral infection.
  10. Evidence of human immunodeficiency virus (HIV antibody positive) infection.
  11. Bone marrow insufficiency.
  12. Any previous or current treatment with complement inhibitors (eg, eculizumab, ravulizumab).
  13. Use of selected medications known to lower the seizure threshold and/or cause seizure.
  14. Participation in another investigational drug or investigational device study running at the same time.
  15. Pregnant, breastfeeding, or intending to conceive during the course of the study.

  Exclusion Criteria for LN Cohort
  1. Prednisone or prednisone equivalent = 0.5 mg/kg/day for = 4 consecutive weeks prior to Screening.
  2. Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg) on 2 or more measurements during the Screening Period.
  3. Prior history or clinically active SLE-related cerebritis, seizures, pericarditis, stroke, or stroke syndrome requiring treatment.

  Exclusion Criteria for IgAN Cohort
  1. Prednisone or prednisone equivalent > 20 mg/day for > 14 consecutive days or any other immunosuppression within 6 months prior to Screening.
  2. Blood pressure of = 140/90 mmHg during the Screening Period confirmed on 2 measures > 30 minutes apart.
  3. Body mass index = 38 kg/m2 during Screening.