Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

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

1. Coverage of the body surface area (BSA) of 10% or more with plaques

2. A score of 3 or more on the IGA scale

3. 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 apply