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Refer a Patient

Have a Patient with Proliferative Lupus Nephritis or Immunoglobulin A Nephropathy Who May Be Interested in the SANCTUARY Study?

The SANCTUARY Study is enrolling approximately 60 participants who have proliferative lupus nephritis (LN) and approximately 60 participants who have immunoglobulin A nephropathy (IgAN).

The SANCTUARY Study is a phase 2, double-blind, randomized study. The total duration of participation is approximately 20 months. The study consists of a screening period, a treatment period, and a follow-up period.

Participants will be randomized 2:1 to receive either the investigational medication (ravulizumab) or a placebo. Neither the participant nor the study team will know which treatment option has been assigned, but in case of an emergency, the study team can quickly find out. Participants in the IgAN placebo group will cross over to treatment with ravulizumab after the first 6 months, so all participants with IgAN will receive treatment. The investigational medication will be administered as an IV infusion.

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Primary Objective

The SANCTUARY Study is evaluating the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with proliferative LN or IgAN. Ravulizumab is an inhibitor of the terminal complement pathway. It provides complete and sustained C5 inhibition, thereby blocking the production of C5a and C5b-9 membrane attach complex. Complement activation is closely linked to the pathophysiology of LN and IgAN.

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Eligibility Criteria

Additional eligibility criteria apply.

Key Inclusion Criteria

  • Participant must be 18 to 75 years of age
  • Has proteinuria ≥ 1
  • Must have:
    • A clinical diagnosis of SLE by 2019 ACR and EULAR criteria and a diagnosis of 2018 Revised ISN/RPS classification (active focal or diffuse proliferative LN Class III, IV, III/V, or IV/V confirmed by biopsy)
    • OR
    • An established diagnosis of primary IgAN based on kidney biopsy
  • Newly diagnosed, relapse patients, and patients on immunosuppressive treatment or starting their first course of immunosuppressive treatment can be considered for eligibility.
  • If clinically needed, additional immunosuppression can be given any time during the study for rescue therapy. If rescue therapy is clinically needed, the choice of agents is per the discretion of the study doctor and may include belimumab.

Key Exclusion Criteria

  • Has eGFR < 30 ml/min/1.73m2
  • Has a history of kidney transplant or planned kidney transplant during the treatment period
  • Has a history of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant, or planned transplant during the treatment period
  • Has clinically active SLE-related cerebritis, seizures, pericarditis, stroke, or stroke syndrome requiring treatment
  • Has a diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 30% over a period of 3 months prior to or during the screening period
  • Has secondary etiologies of IgAN (e.g., SLE, cirrhosis, celiac disease)
  • Newly diagnosed, relapse patients, and patients on immunosuppressive treatment or starting their first course of immunosuppressive treatment can be considered for eligibility.
  • If clinically needed, additional immunosuppression can be given any time during the study for rescue therapy. If rescue therapy is clinically needed, the choice of agents is per the discretion of the study doctor and may include belimumab.