Ravulizumab:
SANCTUARY
Local complement activation in the mesangium appears to influence the extent of glomerular injury in IgAN.C3 is codeposited with IgA in over 90 percent of patients with IgAN. Activation of alternative and lectin complement pathways may lead to generation of the anaphylatoxins C3a and C5a and the membrane attack complex (MAC) C5b-9, with increased inflammation and matrix production in the mesangium.
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Ravulizumab is a monoclonal antibody directed against the C-5 complement component, currently approved for treating Complement Mediated-TMA and Paroxysmal Nocturnal Hemoglobinuria (PNH) and Myasthenia Gravis. Ravulizumab provides complete and sustained C5 inhibition, thereby blocking the production of C5a and C5b-9 MAC.
Enroll in this clinical study
What is the SANCTUARY study?
SANCTUARY is 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).
Trial plans to recruit a total of 120 patients (about 60 IgAN patients). Participants will be assigned at random to receive either Ravulizumab IV infusion every 8 weeks or a placebo, but the study is 2:1 randomized treatment to placebo, which means that all participants are twice as likely to receive the investigational medication as the placebo.
IgAN participants who are in the placebo group will cross over to receive Ravulizumab after the first six months of treatment.
Eligibility Criteria
01
Participant must be 18 to 75 years of age
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Vaccinated against meningococcal infection
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Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months
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Has proteinuria ≥ 1g
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Must have an established diagnosis of primary IgAN based on kidney biopsy
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Vaccinated for Haemophilus influenzae type b (Hib) and Streptoco