This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Incidence of treatment emergent adverse events
Time frame: up to 31 weeks
Incidence of abnormal clinically significant vital signs
Time frame: up to 31 weeks
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Time frame: up to 31 weeks
Incidence of abnormal clinically significant ECG results
Time frame: up to 31 weeks
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax
Time frame: up to 31 weeks
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