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A Study in Patients With Moderate to Severe Psoriasis - NCT01107457-03756(Clinical Trial 655992)



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City:  Lebanon
State:  
NH
Zip Code: 03756
Conditions: Psoriasis
Purpose: The primary purpose for this study is to help answer the following research questions - The safety of LY2439821 and any side effects that might be associated with it. - Whether LY2439821 can help patients with Psoriasis. - How much LY2439821 should be given to patients.
Study summary: Approximately 125 patients will be randomized to 1 of 4 LY2439821 groups or to placebo (approximately 25 patients per group). Patients will be evaluated for treatment efficacy at multiple visits and the primary endpoint will be evaluated at Week 12. Patients will be followed an additional 16 to 24 weeks (32 to 40 weeks total) after the completion of dosing in order to continue safety monitoring and to determine the duration of treatment efficacy.
Criteria: Inclusion Criteria: - You must have active plaque psoriasis covering at least 10% body surface area and a PASI score of 12 - You are a candidate for systemic therapy. - You have a sPGA score of at least 3 at screening and at randomization. Exclusion Criteria: - You have pustular, erythrodermic and/or guttate forms of psoriasis. - You have had a clinically significant flare of psoriasis during the 12 weeks prior to study entry - You are or recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept >28 days, infliximab or adalimumab >56 days, alefacept >60 days, ustekinumab >8 months, or any other biologic agent/monoclonal antibody >5 half-lives prior to baseline - You have received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 [mild, such as desonide] or 7 [least potent, such as hydrocortisone] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia) - You have donated more than 500 mL of blood within the last month - You have another serious disorder or illness - You have suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months - You have a history of uncontrolled high blood pressure - You have clinical laboratory test results at entry that are outside the normal reference range - You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug - You are a woman who is lactating or breast feeding - If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study - If you are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months - If you are a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate - If you are a male, you must agree to reduce the risk of your female partner becoming pregnant during the study
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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