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A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis - NCT01071252-97035(Clinical Trial 562738)



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City:  Lake Oswego
State:  
OR
Zip Code: 97035
Conditions: Chronic Plaque-type Psoriasis
Purpose: The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
Study summary:
Criteria: Inclusion Criteria: Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization At randomization, moderate to severe psoriasis as defined by: - PASI score of 12 or greater and, - IGA score of 3 or greater and, - Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment. Exclusion Criteria: - Forms of psoriasis other than chronic plaque-type - Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization - Previous exposure to AIN457 - Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to - Known immunosuppression (e.g., AIDS) at screening and / or randomization - History or evidence of active tuberculosis at screening - Active systemic infections (other than common cold) - History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years. - Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study - Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study - Inability or unwillingness to undergo repeated venipuntures - History or evidence of drug or alcohol abuse - Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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