Status:
COMPLETED
AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Plaque-type Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 exten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00941031
Start Date
July 1 2009
End Date
December 1 2010
Last Update
August 20 2015
Active Locations (62)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35233
2
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
3
Novartis Investigative Site
Pasadena, California, United States, 91105
4
Novartis Investigative Site
San Diego, California, United States, 92123