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
Brief description of study
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 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.
Detailed description of study
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 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Systemic Lupus Erythematosus (SLE),Lupus,Lupus Erythematosus
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Age: Between 18 Years - 75 Years
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Gender: All
Updated on
21 Sep 2021.
Study ID: 834961