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New ICONIC-ADVANCE 1 Research Study Open for Enrollment
Additional study criteria will apply. All study-required visits, tests, and medication will be provided at no cost. In addition, reimbursement for study-required travel may be provided.
Since you were diagnosed with moderate to severe plaque psoriasis, you have likely talked with your doctor, other medical professionals, your family, caregivers, and friends about your next steps. One option that may be available to you is the ICONIC-ADVANCE 1 research study of an oral investigational medication for moderate to severe plaque psoriasis.
To qualify for this study, you must:
- Be 18 years of age or older.
- Have been diagnosed with moderate to severe plaque psoriasis for at least 6 months prior to beginning this study.
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What is the purpose of this study?The purpose of the ICONIC-ADVANCE 1 study is to help doctors and researchers learn more about the efficacy of the investigational medication. In this study, doctors want to evaluate the investigational medication when it is compared with a medication that is approved to treat moderate to severe plaque psoriasis, which is known as an active comparator medication. The investigational medication is not approved by any regulatory health authority to treat moderate to severe plaque psoriasis. It is only available to patients like you in research studies like this one. The results of this study may provide more information about the investigational medication and whether it could one day be used to treat moderate to severe plaque psoriasis.
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Who can participate in this study?To qualify for this study, you must: • Be 18 years of age or older • Have been diagnosed with moderate to severe plaque psoriasis for at least 6 months prior to beginning this study Additional criteria will apply, which you can discuss with the study doctor/staff.
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What happens if I join this study?If you are eligible for this study and agree to participate, you will receive the investigational medication during your participation. However, initially, you will be randomly assigned (like drawing numbers out of a hat) to receive the investigational medication (Group 1), the active comparator medication (Group 2), or placebo (Group 3). Placebo looks like the investigational medication but contains no active ingredients. You have a: • 2 in 5 chance (40%) of being in Group 1 • 2 in 5 chance (40%) of being in Group 2 • 1 in 5 chance (20%) of being in Group 3 You and the study doctor/staff will not know your study group assignment. In the event of an emergency, this information can be provided. You will take your study medication (investigational, active comparator, or placebo) by mouth once a day. Group 1 • Weeks 0-156: Takes the investigational medication Group 2 • Weeks 0-24: Takes the active comparator medication • Weeks 24-156: Takes the investigational medication Group 3 • Weeks 0-16: Takes placebo • Weeks 16-156: Takes the investigational medication
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Why is placebo used in this study?Using placebo helps the study doctor/staff: • Better understand the effects (good or bad) of the investigational medication • Learn if any effects (good or bad) are caused by the investigational medication
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How long will I be in this study?Your total study participation will last approximately 3 years, which includes screening for eligibility, study medication dosing, and follow-up. You will have regularly scheduled study clinic visits for health exams and tests. For the first year, these visits will occur about once a month. As you continue in the study, these visits will take place once every 2-3 months.
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What are the potential benefits and potential risks related to this study?By being in this study, you could help contribute to research for people with psoriasis in the future. All study-required visits, tests, and medication will be provided at no cost to you. In addition, reimbursement for study-required travel may be provided. While you could benefit from being in this study, that is not guaranteed. It is also possible you could experience side effects while in this study. Before you begin study participation, the study doctor/staff will review the known study risks and possible side effects with you. During the study, you will be closely monitored for any side effects related to your study participation. The study doctor/staff want you to feel safe and comfortable while you’re in this study.
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Can I change my mind about study participation?Yes, if you join the study, you may leave the study at any time and for any reason.