Psoriasis Clinical Trial
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Summary
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).
Eligibility 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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There are 18 Locations for this study
San Diego California, 92123, United States
Louisville Kentucky, 40217, United States
Rochester New York, 14623, United States
Lake Oswego Oregon, 97035, United States
Portland Oregon, 97210, United States
Halifax Nova Scotia, B3H 1, Canada
North Bay Ontario, P1B 3, Canada
Waterloo Ontario, N2J 1, Canada
Tallinn , 10138, Estonia
Tallinn , 13419, Estonia
Tartu , 51014, Estonia
Kopavogur , IS-20, Iceland
Nagoya-city Aichi, 467-8, Japan
Maebashi-city Gunma, 371-8, Japan
Sapporo-city Hokkaido, 060-0, Japan
Saitama-city Saitama, 330-0, Japan
Riga , 1012, Latvia
Riga , LV-10, Latvia
Riga , , Latvia
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