The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
547
SLE response
The % of subjects with SLE response compared with baseline at the time of assessment
Time frame: Various timepoints through Week 52
B cell reduction
Time frame: Various timepoints through Week 52
Time to first flare
Time frame: Various timepoints through Week 52
FACIT-fatigue score
Time frame: Various timepoints through Week 52
Reduction in prednisone dose
Time frame: Various timepoints through Week 52
Change in IgG, IgM,C3 and C4
Time frame: Various timepoints through Week 52
Flare rates
Time frame: Various timepoints through Week 52
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9
Time frame: Various timepoints through Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks
Investigator Site 103
Birmingham, Alabama, United States
Investigator Site 113
Long Beach, California, United States
Investigator Site 108
Los Angeles, California, United States
Investigator Site 110
Upland, California, United States
Investigator Site 105
Orlando, Florida, United States
Investigator Site 102
Tampa, Florida, United States
Investigator Site 117
Baltimore, Maryland, United States
Investigator Site 104
Lansing, Michigan, United States
Investigator Site 106
Lake Success, New York, United States
Investigator Site 114
Smithtown, New York, United States
...and 64 more locations