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Keep this study
Lead
AstraZeneca
With
MedImmune LLC
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
Weight greater than or equal to 40.0 kg.
Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
Active moderate to severe SLE disease based on SLE disease activity score.
You may not be if
Active severe or unstable neuropsychiatric SLE.
Active severe SLE-driven renal disease or unstable renal disease.
Clinically significant active infection including ongoing and chronic infections.
Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
Confirmed positive tests for hepatitis B or positive test for hepatitis C.
