The purpose of this study is to demonstrate the effectiveness and safety of an investigational drug called secukinumab administered subcutaneously (under the skin) in adult patients with newly diagnosed or relapsing giant cell arteritis (GCA). Participants also receive prednisone as an additional study treatment, alongside secukinumab or placebo (inactive substance). Secukinumab has been approved by the U.S. Food and Drug Administration (FDA) for various conditions, but its use in this study is investigational. Secukinumab is a monoclonal antibody, which is a type of protein that binds to unique proteins that the body produces. Secukinumab reduces the activity of a “messenger” protein in the body called interleukin-17A (IL-17A). Researchers believe that IL-17A is involved in the GCA disease process and may be partly responsible for inflammation. A product that inhibits IL-17A may therefore help to relieve the negative effects of the disease and improve symptoms.
What is the full name of this clinical trial?
A randomized, parallel-group, double-blind, placebo controlled, multicenter phase 3 trial to investigate the efficacy and safety of secukinumab 300 mg administered subcutaneously in patients with giant cell arteritis .