A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type 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

NCT01071252

Run by

Novartis Pharmaceuticals

People needed

125

Starts

2010-03-01

Expected to finish

2011-02-01

Last updated by the study team

2015-02-16

Who can join

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

You may qualify if…

• Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
• At 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.

You may not qualify if…

• Forms of psoriasis other than chronic plaque-type
• Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
• Previous exposure to AIN457
• Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
• Known immunosuppression (e.g., AIDS) at screening and / or randomization
• History or evidence of active tuberculosis at screening
• Active systemic infections (other than common cold)
• History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
• Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
• Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
• Inability or unwillingness to undergo repeated venipuntures
• History or evidence of drug or alcohol abuse
• Pregnant or nursing (lactating) women
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Lake Oswego, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Halifax, Nova Scotia, Canada
• Novartis Investigative Site — North Bay, Ontario, Canada
• Novartis Investigative Site — Waterloo, Ontario, Canada
• Novartis Investigative Site — Tallinn, Estonia, Estonia
• Novartis Investigative Site — Tallinn, Estonia
• Novartis Investigative Site — Tartu, Estonia
• Novartis Investigative Site — Kopavogur, Iceland
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan
• Novartis Investigative Site — Maebashi, Gunma, Japan
• Novartis Investigative Site — Sapporo, Hokkaido, Japan
• Novartis Investigative Site — Saitama, Saitama, Japan
• Novartis Investigative Site — Riga, Latvia
• Novartis Investigative Site — Riga, Latvia
• Novartis Investigative Site — Riga, Latvia

Full record on ClinicalTrials.gov

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