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View Clinical Trial (Medical Research Study)
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A Study for Adults With Plaque Psoriasis - NCT01018810-08520 (Clinical Trial 445490)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy445490.aspx
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| City: |
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East Windsor |
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State:
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NJ |
| Zip Code: |
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08520 |
| Conditions: |
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Psoriasis |
| Purpose: |
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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
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| Study summary: |
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| Criteria: |
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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 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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