A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Description

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).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.

Trial 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

Study Info

Interventions

Locations Recruiting

Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.