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AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis | Clinical Trials | Clareo Health

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AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

NCT00941031•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women at least 18 years of age at time of consent
•Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
•At time of 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 and/or
•* phototherapy and/or
•* previous systemic therapy

Exclusion Criteria

•Patients meeting any of the following criteria will be excluded from entry into the study:
•Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
•Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
•Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
•Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
•Known immunosuppression (e.g., AIDS) at screening and / or randomization
•History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
•Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
•At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
•History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
+3 more criteria

Locations (62)

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Little Rock, Arkansas, United States

Novartis Investigative Site

Pasadena, California, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Newnan, Georgia, United States

Novartis Investigative Site

Snellville, Georgia, United States

Novartis Investigative Site

Champaign, Illinois, United States

Novartis Investigative Site

Springfield, Illinois, United States

Novartis Investigative Site

Evansville, Indiana, United States

Novartis Investigative Site

Topeka, Kansas, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

August 20, 2015

Enrollment

404

ACTUAL participants

Conditions

Chronic Plaque-type Psoriasis

Interventions

AIN457

DRUG

AIN457A

DRUG

AIN457A

DRUG

Placebo

DRUG

A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis

NCT04207801

Chronic Plaque-type Psoriasis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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