At a glance
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A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating Anifrolumab 300 mg, Anifrolumab 1000 mg, and 1 other intervention for Systemic Lupus Erythematosus. Completed, enrolled 626 participants across 79 sites in 14 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.
Study Details
Timeline
Interventions
Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.