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A Study in Patients With Moderate to Severe Psoriasis - NCT01107457-63117(Clinical Trial 655990)



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City:  St Louis
State:  
MO
Zip Code: 63117
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: The study is a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B is an optional, open label extension design. Approximately 125 patients will be randomized to 1 of 4 LY2439821 groups or to placebo (approximately 25 patients per group) in Part A. Patients will be evaluated for treatment efficacy at multiple visits and the primary endpoint will be evaluated at Week 12. Between week 20 and week 32, patients with a less than 75% improvement in their PASI score compared to baseline will be eligible to begin Part B. Patients in Part B will receive SC injections of LY2439821 120 mg every 4 weeks thereafter through Week 240. Patients who complete both Part A and B have a total study participation of up to approximately 240 to 264 week
Criteria: Inclusion Criteria Common to Both Part A and B: - 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. Inclusion Criterion Specific to Part B - You have completed the treatment period for part A (week 20) Exclusion Criteria Common to Both Part A and B: - 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 Exclusion Criteria Specific to B: - If you experienced a Serious Adverse Event during Part A considered possibly related to LY2439821 - If you experienced an Adverse Event during Part A that the study doctor believes LY2439821 treatment could cause you harm
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: November 12, 2010
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