A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects with Active Systemic Lupus Erythematosus (SLE) with Inadequate Response to Standard of Care (SOC) Therapy--Amgen Global Version 2

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Study Overview

The purpose of the study is to evaluate safe and effective doses of AMG 570 for the treatment of active SLE in patients who are not responding to the current standard of care. AMG 570 at 3 dose levels (70, 280 and 420 mg) will be compared to placebo. The placebo will look like AMG 570 but it will not contain active ingredients. Taking placebo is the same as not taking any additional drugs beyond your current therapies for your condition. AMG 570 and placebo are both called study drug in this form. 

Study Description

The purpose of the study is to evaluate safe and effective doses of AMG 570 for the treatment of active systemic lupus erythematosus (SLE) in patients who are not responding to the current standard of care. AMG 570 at 3 dose levels (70, 280 and 420 mg) will be compared to placebo. The placebo will look like AMG 570 but it will not contain active ingredients. About 300 people will be asked to participate. Four individuals will be recruited at Penn. You will have 32 visits to the Penn dermatology clinic during the study. The visits will take approximately 1 hour to 4 hours, depending on the study visit, and they will take place approximately 2 times a month.

  • Study Identifier: 834961

Recruitment Status

Open

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