If you have moderate-to-severe plaque psoriasis, you may be eligible to participate in our clinical study of a new experimental medication.
Psoriasis is a type of autoimmune disease, afffecting 1.6 million Australians. In psoriasis, the immune system mistakenly attacks the body, leading to a chronic inflammatory skin disorder. Plaque psoriasis is the most common type of psoriasis.
Plaque psoriasis typically appears as raised, red patches on the scalp, knees, elbows and lower back. The patches may have a white build-up of dead skin cells with skin flaking, and can be painful or itchy.
Beyond the physical discomfort, plaque psoriasis can have a real impact on daily life. Although many people with moderate-to-severe plaque psoriasis manage the condition with creams and lotions or other types of medications, for some this is not enough –which is why we are doing this clinical research study.
Reference: http://www.psoriasisaustralia.org.au accessed 31 May 2019.
Clinical research studies explore whether a study drug is safe and effective for patients. Study drugs are approved (or rejected) for medical use by health authorities or regulatory bodies like the FDA based on data from clinical research studies.
Clinical research studies are important because they:
The name of the trial is POETYK-PsO (pronounced “poetic” and PSO stands for Psoriasis). This clinical research study will evaluate a new potential therapy for plaque psoriasis. Our study is investigating a first of its kind oral medication, designed to work on the body’s immune system to help manage psoriasis, by blocking a protein called TYK2 (pronounced ‘tick 2’) inside cells. The study is designed to look at how safe, effective and long-lasting the medication is in individuals with moderate-to-severe plaque psoriasis. Study participation will last about 14 months, with regular visits to the study center.
By studying a new investigational medication for plaque psoriasis, we hope to work towards creating new and better treatment options to improve quality of life for patients.
You won’t be asked for any personal information until after you have completed the questionnaire and decided to proceed. Your information will only be used for the purpose of this study.
Discuss participation in this study with your dermatologist, then complete our pre-screening questionnaire. Once you complete the questionnaire and submit your contact information, you’ll receive a call to discuss the study in more detail. If you qualify, you’ll then schedule your first office visit. There, you’ll beasked to review and sign aninformed consent document with detailed information about the study, including what will be expected of you if you participate. Once you’ve signed the consent form, the study team will begin the screening process, which can last up to 4 weeks. You can expect to be examined by a trained medical team, and you’ll receive additional tests to see if you meet the medical requirements of the study.
Once you sign the informed consent and successfully complete the screening process, you can expect the following:
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