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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Biological: AIN457; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770965

CAIN457A2204

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

AIN457 0.3 mg/kg

Experimental group

Description:

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

Treatment:

Biological: AIN457

AIN457 1.0 mg/kg

Experimental group

Description:

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

Treatment:

Biological: AIN457

AIN457 3.0 mg/kg

Experimental group

Description:

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

Treatment:

Biological: AIN457

Placebo

Placebo Comparator group

Description:

Participants received placebo to AIN457A IV on day 1.

Treatment:

Biological: Placebo