Ravulizumab is a long-acting terminal complement inhibitor that specifically binds to the complement protein C5 in the terminal complement pathway, inhibiting the activation of the terminal complement cascade.
How is Ravulizumab being studied in Lupus nephritis?
The efficacy and safety of Ravulizumab in adult participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) is being studied in this phase 2, Double-Blind, Randomized, Placebo-Controlled Study. The primary outcome is the percentage change in proteinuria from baseline to week 26 in both cohorts. Eligible participants will receive Ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks) vs placebo. During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Eligibility Criteria:
Common to both 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
Link to SANCTUARY trial
