Psoriasis Clinical Trial

Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis

Summary

This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

Coverage of the body surface area (BSA) of 10% or more with plaques
A score of 3 or more on the IGA (Investigator Global Assessment) scale

A PASI score of at least 12 at baseline;

Exclusion Criteria:

Have forms of psoriasis other than the required "plaque psoriasis"
Women of childbearing potential
Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
Previous treatment with this investigational drug
Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities

Other protocol-defined inclusion/exclusion criteria may have applied.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT00770965

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 5 Locations for this study

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Novartis Investigative Site
Santa Monica California, 90404, United States
Novartis Investigative Site
Louisville Kentucky, 40217, United States
Novartis Investigative Site
High Point North Carolina, 27262, United States
Novartis Investigative Site
Duncansville Pennsylvania, 16634, United States
Novartis Investigative Site
Nashville Tennessee, 37215, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT00770965

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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