A Multicenter Randomized Double-blind Placebo- controlled Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

Brief description of study

SLE is a chronic autoimmune disease in which the immune system attacks the body’s cells and tissue, and can affect almost any organ system. The drug used in this study is called ustekinumab. The purpose of this study is to analyze the effect (both good and bad) of ustekinumab in patients with active systemic lupus erythematosus (SLE). The safety of ustekinumab will also be studied. Ustekinumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with other immune diseases, such as adult and adolescent chronic moderate to severe plaque psoriasis, adult active psoriatic arthritis, and adult moderate to severely active Crohn’s disease. It is sold as STELARA®. Ustekinumab was studied in subjects with SLE in a previous clinical study with the same type of dosing schedule that will be further evaluated in this study.


Clinical Study Identifier: s18-01001
ClinicalTrials.gov Identifier: NCTs18-01001


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