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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00669916
First received: April 29, 2008
Last updated: July 31, 2012
Last verified: July 2012
  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
Biological: AIN457
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 36
Study Start Date: February 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: AIN457
Two treatment groups; single infusion of 3 mg/kg or placebo.
Other Name: (AIN457), a fully human recombinant IgG1 antibody.
Placebo Comparator: 2 Biological: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Goodlettsville, Tennessee, United States, 37072
Novartis Investigator Site
Nashville, Tennessee, United States, 37215
United States, Washington
Novartis Investigator Site
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00669916     History of Changes
Other Study ID Numbers: CAIN457A2102
Study First Received: April 29, 2008
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014