AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Plaque-type Psoriasis

In brief

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).

Key facts

Study ID

NCT00941031

Run by

Novartis Pharmaceuticals

People needed

404

Starts

2009-07-01

Expected to finish

2010-12-01

Last updated by the study team

2015-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Newnan, Georgia, United States
• Novartis Investigative Site — Snellville, Georgia, United States
• Novartis Investigative Site — Champaign, Illinois, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Clinton Twp., Michigan, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Henderson, Nevada, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — High Point, North Carolina, United States
• Novartis Investigative Site — Lake Oswego, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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