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 Overview
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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.

Official Title
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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

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Biological: AIN457
* Biological: Placebo


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457 0.3 mg/kg<br>Participants received AIN457 0.3 mg/kg IV on Day 1. | Biological: AIN457<br> <br> |
| Experimental: AIN457 1.0 mg/kg<br>Participants received AIN457 1.0 mg/kg IV on Day 1. | Biological: AIN457<br> <br> |
| Experimental: AIN457 3.0 mg/kg<br>Participants received AIN457 3.0 mg/kg IV on Day 1. | Biological: AIN457<br> <br> |
| Placebo Comparator: Placebo<br>Participants received placebo to AIN457A IV on day 1. | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | baseline, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in PASI | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | baseline, weeks 12, 14, 16, 20, 24, 28 and 32 | 
| Investigator Global Assessment (IGA) Scores | This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants. | baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease