A phase 3 multicenter randomized double-blind placebo-controlled active reference (adalimumab) study evaluating the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis

Brief description of study

Psoriasis is a long-term skin disease in which the skin cells grow abnormally causing a buildup of cells which appears as red, raised patches covered with silver colored scales on the surface of the skin. Psoriatic arthritis is usually a combination of skin and joint disease. Psoriatic arthritis is a long-term disorder causing swelling in multiple joints, which occurs in most of the people affected by psoriasis. Patients with psoriatic arthritis experience continuously increasing, severe pain in joints that is accompanied by tiredness and functional impairment. Biologic disease modifying antirheumatic drugs are the drugs which slows down the progression of psoriasis and/or psoriatic arthritis. The purpose of this study is to help understand how safe and effective a new drug called bimekizumab is in subjects who have not received any biologic disease modifying antirheumatic drugs until the time of the start of this study. Bimekizumab is a new drug that may eventually be used in the treatment of psoriatic arthritis. It is investigational, which means that is it still being tested, and has not yet been approved for treatment by the United States Food and Drug Administration (FDA). Bimekizumab is a monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body. Bimekizumab belongs to a group of medicines called interleukin (IL) inhibitors. Bimekizumab reduces the activity of two proteins called IL-17A and IL-17F, which are involved in psoriatic arthritis and other inflammatory diseases. Studies in animals showed that reduction of IL-17 might help the treatment of inflammatory diseases. To date,731 adults have been given bimekizumab in studies that included healthy volunteers, as well as subjects with psoriasis, psoriatic arthritis and ankylosing spondylitis. In these studies, bimekizumab was generally well tolerated by the people who received it.


Clinical Study Identifier: s19-00412
ClinicalTrials.gov Identifier: NCT03895203


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