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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-10

Study Completion Date

2009-09-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AIN457 0.3 mg/kg

Participants received AIN457 0.3 mg/kg IV on Day 1.

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

AIN457 1.0 mg/kg

Participants received AIN457 1.0 mg/kg IV on Day 1.

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

AIN457 3.0 mg/kg

Participants received AIN457 3.0 mg/kg IV on Day 1.

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

Placebo

Participants received placebo to AIN457A IV on day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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AIN457

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No