A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis - Tabular View

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A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis

This study has been completed.

Study NCT00669916. Last updated on November 21, 2008. Information provided by Novartis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis

Official Title ^†

Phase 2a Single-Dose, Randomized, Double Blind, Multi-Center, Parallel-Group, Placebo-Controlled Proof of Concept Study to Assess the Efficacy, Safety, Tolerability, and Population Pharmacokinetics of AIN457 in Patients With Stable Plaque-Type Psoriasis

Brief Summary

This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at baseline and subjects will be observed for up to 26 weeks following the infusion.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Basic Science, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

To evaluate the preliminary efficacy of AIN457 when administered as a single dose infusion to patients with stable plaque psoriasis; proof-of-concept study comparing 3mg/kg of AIN457 to placebo [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
The comprimary efficacy endpoints will be the Psoriasis Area and Severity Index (PASI) measure at 4 weeks after the infusion and the number of responses as determined by the Investigator's global assessment (IGA). [ Time Frame: At week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Characterize compound in blood, in plaque [ Time Frame: throughout the duration of the study ] [ Designated as safety issue: No ]
Perform exploratory analysis [ Time Frame: throughout the duration of the study ] [ Designated as safety issue: No ]

Condition ^†

Plaque Psoriasis

Intervention ^†

Biological: AIN457
Biological: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

February 2007

Completion Date

November 2007

Eligibility Criteria ^†

Inclusion Criteria:

Males or females, aged 18-69 at time of consent.
Post menopausal or surgically sterile female patients are allowed. Male patients must be willing to use contraception method at least for 3 months following the completion of the study. Women of child-bearing potential will not be allowed to participate.
Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet both 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 scale
Stable plaque psoriasis at screening and randomization.
PASI score of 12 or greater at randomization.
Able to communicate well with the investigator, and to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Patients must have normal laboratory values for screening laboratory test results of hematological (hemoglobin, WBCs, neutrophils, platelets) and renal (serum creatinine) assessments. For the transaminases, aspartate aminotransferase and alanine aminotransferase, levels 1.5 times the upper limit of normal will be accepted. For the additional hepatic laboratory results (alkaline phosphatase, gamma-glutamyltransferase, bilirubin), patients must have non-clinically significant values.

Exclusion Criteria:

Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
Men who are planning to initiate a pregnancy while enrolled in the study or for 3 months following completion of the study.
Women of child-bearing potential are not allowed in the study.
Used any investigational drug within the previous 4 weeks.
Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
1. 2 months washout prior to screening for etanercept, adalimumab, or infliximab.
2. 1 month washout prior to screening for cyclosporine, mycophenolate, tacrolimus, and any systemic immunosuppressants including, but not limited to, methotrexate, azathioprine, 6-thioguanine, mercaptopurine, and hydroxyurea

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00669916

Organization ID

CAIN457A2102

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Principal Investigator:

Novartis

Novartis investigator site

Information Provided By

Novartis

Verification Date

November 2008

First Received Date ^†

April 29, 2008

Last Updated Date

November 21, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.