Additional Relevant Details
The Phase 2 study in SLE is a randomized, double-blind, placebo-controlled, multiple dose trial being conducted in the US at approximately 20 sites. Approximately 90 SLE patients will be enrolled with a 1:1 randomization of XmAb5871 to placebo. Patients will enter screening with active, non-organ threatening SLE. They will discontinue background immunosuppressive medication and receive a short course of IM steroids to quiet SLE disease activity. Patients who achieve the required disease activity improvement will be randomized to receive XmAb5871 or placebo every two weeks for up to 12 infusions (six months) and will be followed for loss of disease improvement. The primary objective of the study is to evaluate the ability of XmAb5871 to maintain SLE disease activity improvement achieved by a brief course of disease-suppressing IM steroid therapy. Secondary and exploratory objectives are to evaluate the time to loss of SLE disease activity improvement, to determine the safety and tolerability profile, to characterize the pharmacokinetics and pharmacodynamics (change in biomarkers), and to characterize immunogenicity of every other week IV administration of XmAb5871 in patients with SLE.