AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2009
End Date:December 2010

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A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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).


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
We found this trial at
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Philadelphia, Pennsylvania 19102
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Portland, Oregon 97228
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Rochester, New York 14615
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