Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Treatments: Ravulizumab

Criteria

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) for > 14 consecutive days or any other immunosuppression within 6 months