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Is Psoriasis Making You Hide?

If you have moderate-to-severe plaque psoriasis, you may be eligible to participate in our clinical study of a new experimental medication.

See if you might qualify

About Plaque Psoriasis

About Plaque Psoriasis

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.

See if you might qualify

What is a clinical research study?

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:

  • Help answer specific health questions
  • Help improve patient care
  • Help advance medical knowledge

About the POETYK-PsOClinical Study

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.

I’m Interested, What’s Next?

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.

What Can I Expect if I Participate?

Once you sign the informed consent and successfully complete the screening process, you can expect the following:

  • You will receive either the study medication, a placebo (pill that contains no active ingredients), or a comparator medication (a currently approved medication for psoriasis) -all to be taken orally twice a day. Because it is important to get unbiased results, you will not know which one you will be given.
  • Study participation will last approximately 14 months.
  • You will need to visit the study center 18 times. During these regular office visits, the clinical study team will monitor your health and overall condition. Some of the assessments you can expect are physical exams, blood tests, heart monitoring, and pregnancy testing (if you are female). As part of the study, you will be required to record your psoriasis symptoms in a study diary.
  • Participation is totally voluntary, so you can withdraw at any time.
  • If you qualify, you’ll receive all study-related medical care and study-related medications at no cost to you.

Frequently Asked Questions

  • More about how clinical trials work

    What happens during a clinical study?

    During a clinical study, you may receive the medication that is being studied (called the investigational medication), a placebo (a substance that has no therapeutic effect) or another kind of medication, depending on the design of the study. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication. To ensure safety, all participants are closely monitored by clinic staff and medical team at all times.

    Who can participate in a clinical study?

    Every study has its own specific requirements as to who can participate. In some cases, participants are healthy volunteers; in others, participants may actually have the disease or condition for which the study medication is intended to treat.

    Are clinical studies safe?

    The safety of study participants is the main priority of the clinic staff and medical team. All are closely monitored. Participants may experience side effects in some cases and should alert the medical team when this happens.

    What is a clinical trial?

    A clinical trial, also known as a clinical research study, is a scientific study that evaluates the safety and effectiveness of an investigational drug. A clinical trial may show that the investigational drug is better than, as good as, or worse than the standard treatment or inactive placebo. Qualified doctors, nurses and other medical professionals are responsible for conducting the study. It is through the completion of clinical trials that investigational drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries may provide this approval after a thorough review. Most prescription medications in use today were first proven to be safe and effective during clinical trials.

    Who oversees clinical trials?

    To help ensure that a clinical trial is ethical and that participants' rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve clinical trial protocols that detail all aspects of how the study is conducted. In addition, study monitors, also known as clinical research associates, visit the study clinics to confirm the study protocol procedures and clinical trial requirements and regulations are being followed throughout the study. Health authorities may also inspect the study clinics to ensure the safety and rights of participants in a trial and the integrity of the clinical trial objectives are being maintained.

    Who can participate in a clinical trial?

    Only participants who meet all required eligibility criteria for a clinical trial may take part. The study team at the clinic you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the trial. You may also be asked to provide information from your medical records to help the study team determine if you could be eligible.

    Are there any risks involved in taking part in the POETYK-PsO study?

    You should know that your health may improve, it may stay the same, or it could get worse. Unexpected side effects are always a possibility. That’s why it’s important that you tell the study team if you experience anything unusual during your time on the study.

    Do I have to take part in the POETYK-PsO study?

    No. Taking part in the POETYK-PsO study is completely voluntary. Participants can withdraw from the study at any time. If you do decide that you no longer wish to participate, we would ask you to attend a follow-up visit so that we can just check your health. This may also help us to learn more about the clinical study drug, which could help people with psoriasis in the future.

    What is a screening process?

    Everyone who volunteers for a clinical study undergoes a thorough screening process to determine whether he or she is eligible. Once you complete the on-line questionnaire and pre-qualify, the next step in the screening process is to speak with a member of the study team, who will decide if the potential participant meets the criteria and should have a study center visit. The study center visit includes medical tests and other health assessments.

    What is in the informed consent document?

    An informed consent is a document you’ll need to sign before participating in a clinical study. It provides details about the study, including possible risks and benefits. It gives specific information on what you’ll need to do in order to participate and your rights as a study participant.

    Can I participate if I’m pregnant or planning to become pregnant?

    Women cannot take part in the POETYK-PsO study if they are pregnant, breastfeeding, or planning to become pregnant during the study period. If you enter the study, you are required to use a highly effective birth control method during the treatment period and for 5 weeks after taking the last dose of the new psoriasis drug. All women of childbearing potential will have pregnancy tests during the study. Male participants who have a partner who may become pregnant must use contraception during the treatment period (52 weeks) and must not donate sperm during the treatment period, plus 33 days after taking the last dose of the study drug.
  • About the study drug

    What is an study drug?

    An study drug is a product that has not yet been approved by appropriate regulatory authorities (e.g., the U.S. Food and Drug Administration) for medical use.

    What is the name of the study drug?

    Because this drug is still being evaluated and has not been approved by a health authority, it does not have a name. Instead, it is referred to as TYK2.

    Why is the study drug being studied?

    The study medication is a first-of-its-kind oral non-biologic medication designed to work with the body’s immune system to help manage psoriasis by blocking a protein called TYK2 (pronounced ‘tick 2’). The study is designed to look at how safe, effective and long-lasting the medication is in individuals with moderate-to-severe plaque psoriasis.
  • Privacy, Participation and Reimbursement:

    What happens to personal information?

    The study team respects and protects your privacy and will not share your personally identifiable information except as required by law. Your identity will not be revealed in any study report or publication. The study team will store your personally identifiable information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.

    Can I withdraw from the clinical trial after I have started?

    Your participation in the clinical trial is entirely voluntary, and you may withdraw at any time. If you withdraw from the study, you must notify the study team before doing so. You will be asked to return to the clinic at least once to complete a final visit and return any unused study drug.

    Do I have to pay to participate in the clinical trial?

    There is no charge for taking part. All study-related assessments and the study drug are provided at no charge. You may be responsible for other costs (for example, tests you would receive as part of regular care for your condition), some of which may be covered by your insurance.

    Will I be paid for taking part/ reimbursed for travel?

    You will not be paid for taking part in the clinical trial. The study team can inform you about reimbursement for reasonable travel expenses incurred to attend study visits if you are eligible and are referred to a clinic.

    Does my doctor have to give his/ her permission?

    Your doctor does not have to give his/her permission for you to take part. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep him/her up to date about your progress.

Have questions? Email Us

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