Clinical Research Studies

This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of an SC treatment regimen of anifrolumab versus placebo in adult patients with moderately-to-severely active, autoantibody-positive SLE despite receiving SOC. Subjects must be receiving stable SOC prior to Screening consisting of any of the following: OCS monotherapy, OCS plus antimalarials and/or immunosuppressants (azathioprine, antimalarials, mycophenolate mofetil / mycophenolic acid, methotrexate, or mizoribine); or immunosuppressants with or without OCS; please refer to the Section X- Inclusion Criteria for more detail. Approximately 360 subjects will be randomized in a 1:1 ratio to receive a fixed SC dose of anifrolumab (120 mg) or placebo QW with the primary endpoint evaluated at Week 52. Investigational product (IP) will be administered SC via an aPFS. All patients with a baseline prednisone (or equivalent) dose of = 10.0 mg/day must attempt tapering of their baseline dose to = 7.5 mg/day. Tapering will start at Week 8 and continue through Week 40, unless there are signs of increased disease activity. This study includes: • A screening period of up to 30 days • A 52-week double-blind treatment period with a total of 52 anifrolumab or placebo doses • A 10-week safety follow-up after last IP dose