Overview
The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).
Description
This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.
Eligibility
Inclusion Criteria:
Common to both disease cohorts:
- Proteinuria ≥1 (gram [g]/day or g/g)
- Vaccinated against meningococcal infection
- Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements
For LN cohort:
- Diagnosis of active focal or diffuse proliferative LN Class III or IV
- Clinically active LN, requiring/receiving immunosuppression induction treatment
For IgAN cohort:
- Diagnosis of primary IgAN
- Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months
Exclusion Criteria:
Common to both disease cohorts:
- eGFR < 30 milliliters/minute/1.73 meters squared
- Previously received a complement inhibitor (for example, eculizumab)
- Concomitant significant renal disease other than LN or IgAN
- History of other solid organ or bone marrow transplant
- Uncontrolled hypertension
For IgAN cohort:
- Diagnosis of rapid progressive glomerulonephritis
- Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive days or any other immunosuppression within 6 months
