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

Status:	Completed
Conditions:	Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	18 - 65
Updated:	4/17/2018
Start Date:	September 10, 2008
End Date:	September 17, 2009

Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis

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.

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 (Investigator Global Assessment) 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 have applied.

We found this trial at

sites

Novartis Investigative Site

Duncansville, Pennsylvania 16635

from

Duncansville, PA