This clinical research study is looking for adults 18 years of age and older who have been diagnosed with moderate to severe psoriasis of the genital area. The study drug is being investigated to see if it can help relieve symptoms associated with genital psoriasis.
The purpose of this study is to investigate how effective the study drug is compared to a placebo (a pill with no study drug) and to learn if the study drug can improve symptoms of genital psoriasis over the course of 16 weeks of administration. Individuals will be evaluated to determine if they qualify to participate in this clinical study. Each person who qualifies will receive either the study drug or a placebo, as well as study-related medical exams and laboratory tests, at no cost.
The drug being investigated in the DISCREET Study is called CC-10004, also known as apremilast. Apremilast is thought to work by blocking an enzyme in the body that is usually elevated in people with medical conditions involving inflammation, such as psoriasis (inflammation of the skin). For this study, apremilast will be provided in tablet form and taken by mouth. Although apremilast has been approved in more than 50 countries worldwide including the US, Canada and Europe for the treatment of moderate to severe plaque psoriasis, it has not been approved for genital psoriasis.
Taking any medication can potentially cause side effects, and apremilast’s side effects have been recorded based on feedback from approximately 7,200 patients who received this drug in clinical studies for psoriasis, psoriatic arthritis, Behcet’s disease, ankylosing spondylitis, and ulcerative colitis. The most common side effects include diarrhea and nausea. Please talk to the study doctor for additional information on side effects.
If you are a patient diagnosed with chronic plaque psoriasis, you are no stranger to itchy, painful patches on your body. Those with genital psoriasis develop these patches in the genital area. Between one-third and two-thirds of people with psoriasis will experience genital psoriasis at some point in their lives. This means that, of the roughly 125 million people diagnosed with psoriasis worldwide, at least 41.6 million people also have genital psoriasis, so you are not alone.