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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.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00669916
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: AIN457
Drug: Placebo
Phase I
Phase II

MedlinePlus related topics:   Psoriasis   

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • This study will have two primary endpoints which are the reduction in PASI score from baseline to 4 weeks of follow-up and the number of responses as determined by an IGA.
  • Efficacy of AIN457 will be evaluated by comparing the coprimary endpoint of the reduction in PASI score between the placebo and treatment arms

Secondary Outcome Measures:
  • To evaluate the safety of AIN457 when administered as a single dose infusion to patients with stable plaque psoriasis
  • To evaluate the population pharmacokinetics of AIN457 when administered as a single dose infusion to patients with stable plaque psoriasis
  • Characterize the binding kinetics of IL-17/AIN457 complex in blood
  • Characterize the pharmacodynamics of AIN457 in a sentinel plaque
  • Conduct exploratory genomic, proteomic and metabolomic studies to identify gene expression patterns, proteins, and metabolites of blood that are associated with treatment response to AIN457.
  • Perform exploratory analysis of soluble protein markers (by multiplex based immunoassay in serum) and, when applicable, exploratory Pharmacogenomic analysis of skin biopsy if clinical and/or histological response has been demonstrated

Enrollment:   36
Study Start Date:   March 2007
Study Completion Date:   February 2008
Primary Completion Date:   February 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: AIN457
Two treatment groups; single infusion of 3 mg/kg or placebo.
2: Placebo Comparator Drug: Placebo
Two treatment groups; single infusion of 3 mg/kg or placebo.

  Eligibility
Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669916

Locations
United States, California
Novartis Investigator Site    
      Santa Monica, California, United States, 90211
United States, Kentucky
Novartis Investigator Site    
      Louisville, Kentucky, United States, 40217
United States, New York
Novartis Investigator Site    
      Rochester, New York, United States
Novartis Investigator Site    
      Stonybrook, New York, United States, 11790
United States, North Carolina
Novartis Investigator Site    
      High Point, North Carolina, United States, 27262
United States, Pennsylvania
Novartis Investigator Site    
      Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
Novartis Investigator Site    
      Nashville, Tennessee, United States, 37215
Novartis Investigator Site    
      Goodlettsville, Tennessee, United States, 37072
United States, Washington
Novartis Investigator Site    
      Seattle, Washington, United States, 98101

Sponsors and Collaborators
Novartis

Investigators
Principal Investigator:     Novartis     Novartis investigator site    
  More Information

Responsible Party:   Novartis ( External Affairs )
Study ID Numbers:   CAIN457A2102
First Received:   April 29, 2008
Last Updated:   May 7, 2008
ClinicalTrials.gov Identifier:   NCT00669916
Health Authority:   United States: Food and Drug Administration

Keywords provided by Novartis:
Plaque psoriasis  

Study placed in the following topic categories:
Antibodies
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 29, 2008




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