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View Clinical Trial (Medical Research Study)
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AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis - NCT00941031-10029 (Clinical Trial 302379)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy302379.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10029 |
| Conditions: |
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Chronic Plaque-type Psoriasis |
| Purpose: |
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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).
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Men or women at least 18 years of age at time of consent
- Chronic plaque-type psoriasis diagnosed for at least 6 months at time of
randomization
- At time of 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 and/or
- phototherapy and/or
- previous systemic therapy
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from entry into the study:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
guttate psoriasis) at screening or randomization
- Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers,
calcium channel inhibitors or lithium) and randomization
- Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic
corticosteroids, UV therapy) at randomization. Washout periods detailed in the study
protocol have to be adhered to
- Ongoing use of other prohibited treatments at randomization. Washout periods detailed
in the study protocol have to be adhered to. All prior concomitant medications must
be on a stable dose for at least four weeks before study drug administration
- Known immunosuppression (e.g., AIDS) at screening and / or randomization
- History or evidence of active tuberculosis at screening. All patients will be tested
for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients
with evidence of latent tuberculosis may enter the trial after sufficient treatment
has been initiated according to local regulations.
- Active systemic infections (other than common cold) during the two weeks before
randomization (e.g., hepatitis)
- At screening, history or symptoms of malignancy of any organ system (other than
history of basal cell carcinoma and / or up to three squamous cell carcinomas of the
skin, if successful treatment has been performed, with no signs of recurrence;
actinic keratoses, if present at screening, should be treated according to standard
therapy before randomization), treated or untreated, within the past 5 years,
regardless of whether there is evidence of local recurrence or metastases
- History of congestive heart failure (NYHA functional classification ≥III) at
screening and / or randomization
- History of severe hypersensitivity to any human or humanized biological agents
(antibody or soluble receptor) at screening and / or randomization
- Any severe, progressive or uncontrolled medical condition at randomization that in
the judgment of the investigator prevents the patient from participating in the study
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply. |
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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 2, 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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