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Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00770965
First received: October 9, 2008
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.


Condition Intervention Phase
Chronic Plaque Psoriasis
 Biological: AIN457
Biological: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the difference in the change in baseline in Psoriasis Area and Severity Index (PASI) scores between placebo and each of the active three treatment arms [ Time Frame: At week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the difference in the change from baseline in Psoriasis Area and Severity Index (PASI) scores between placebo and each of the active three treatment arms. [ Time Frame: At week 12 and other timepoints ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2008
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: AIN457
Experimental: 2 Biological: AIN457
Experimental: 3 Biological: AIN457
Placebo Comparator: 4 Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all 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

    3. A PASI score of at least 12 at baseline

      Exclusion Criteria:

  • Have forms of psoriasis other than the required "plaque psoriasis"
  • Women of childbearing potential
  • Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
  • Previous treatment with this investigational drug
  • Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770965

Locations
United States, California
Novartis Investigator Site
Beverly Hills, California, United States, 90211
Novartis Investigator Site
Santa Monica, California, United States, 90404
United States, Kentucky
Novartis Investigator Site
Louisville, Kentucky, United States, 40217
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00770965     History of Changes
Other Study ID Numbers: CAIN457A2204
Study First Received: October 9, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease

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

ClinicalTrials.gov processed this record on May 21, 2013