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A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

NCT ID: NCT01071252

Last Updated: 2015-02-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

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Detailed Description

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Conditions

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Chronic Plaque-type Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AIN457 1x25mg

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

AIN457 3x25mg

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

AIN457 3x75mg

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

AIN457 3x150mg

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AIN457

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

At randomization, moderate to severe psoriasis as defined by:

* PASI score of 12 or greater and,
* IGA score of 3 or greater and,
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.

Exclusion Criteria

* Forms of psoriasis other than chronic plaque-type
* Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
* Previous exposure to AIN457
* Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
* Known immunosuppression (e.g., AIDS) at screening and / or randomization
* History or evidence of active tuberculosis at screening
* Active systemic infections (other than common cold)
* History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
* Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
* Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
* Inability or unwillingness to undergo repeated venipuntures
* History or evidence of drug or alcohol abuse
* Pregnant or nursing (lactating) women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

Louisville, Kentucky, United States

Site Status

Novartis Investigative Site

Rochester, New York, United States

Site Status

Novartis Investigative Site

Lake Oswego, Oregon, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Site Status

Novartis Investigative Site

North Bay, Ontario, Canada

Site Status

Novartis Investigative Site

Waterloo, Ontario, Canada

Site Status

Novartis Investigative Site

Tallinn, Estonia, Estonia

Site Status

Novartis Investigative Site

Tallinn, , Estonia

Site Status

Novartis Investigative Site

Tartu, , Estonia

Site Status

Novartis Investigative Site

Kopavogur, , Iceland

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Maebashi, Gunma, Japan

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Saitama, Saitama, Japan

Site Status

Novartis Investigative Site

Riga, , Latvia

Site Status

Novartis Investigative Site

Riga, , Latvia

Site Status

Novartis Investigative Site

Riga, , Latvia

Site Status

Countries

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United States Canada Estonia Iceland Japan Latvia

Related Links

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http://www.novartisclinicaltrials.com

Click here for more information about this study:

Other Identifiers

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2009-016807-42

Identifier Type: -

Identifier Source: secondary_id

CAIN457A2220

Identifier Type: -

Identifier Source: org_study_id

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