View Clinical Trial (Medical Research Study)

A Study for Adults With Plaque Psoriasis - NCT01018810-42301(Clinical Trial 445489)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Owensboro
State:  
KY
Zip Code: 42301
Conditions: Psoriasis
Purpose: In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis
Study summary:
Criteria: Inclusion criteria: - Are ambulatory and greater than or equal to 18 years of age. Females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate(<1% per year) during the study. - Chronic psoriasis vulgaris for at least 6 months prior to randomization. - Moderate and severe (plaque) psoriasis involving at least 10% body surface area (BSA) or at least 8% BSA in subjects with severe palmar-plantar involvement at randomization. - PASI total score of at least 12 at screening. Exclusion criteria: - Have had a clinically significant flare of psoriasis during the 12 weeks prior to randomization or a biologic agent/monoclonal antibody within the longer of 5 half lives or 12 weeks prior to dosing, had systemic treatment for psoriasis or phototherapy within 4 weeks prior to dosing, or had topical psoriasis treatment within 2 weeks prior to dosing. - Have had a vaccination within 4 to 12 weeks (depending on type) prior to or intend to have one within 4 weeks after the dosing period. - Are immunocompromised or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus [HIV]); or have had a recent serious systemic infection (such as mononucleosis or herpes zoster). - Have a history of or current lymphoproliferative disease or malignant disease (except for resolved cervical dysplasia; or no more than 3 successfully treated basal- or squamous- cell carcinomas of the skin), or severe drug allergies/hypersensitivity. - Have a history of serious cardiac disease within 12 weeks before randomization; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study. - Have laboratory test values outside the reference range for the population or investigative site that are considered clinically significant and/or have any of the following specific abnormalities: - Aspartate transaminase (AST) or alanine transaminase (ALT) >2 x the upper limit of normal (ULN; upper reference range of the central laboratory for the study) - Hemoglobin <100 g/L (10 g/dL) - WBC <3.0 G/L (3,000/mm3) - Neutrophils <1.5 G/L (1,500/mm3) - Platelets <75 G/L (75,000/mm3) - Serum creatinine >133 µmol/L (1.5 mg/dL) - Random glucose >11.1mmol/L (200 mg/dL). - Have significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids
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.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.