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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:
ClinicalTrials.gov Identifier:
NCT00770965
First Posted: October 10, 2008
Last Update Posted: April 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: baseline, week 4 ]
    This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.


Secondary Outcome Measures:
  • Change From Baseline in PASI [ Time Frame: baseline, weeks 12, 14, 16, 20, 24, 28 and 32 ]
    This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.

  • Investigator Global Assessment (IGA) Scores [ Time Frame: baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32 ]
    This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.


Enrollment: 80
Study Start Date: September 2008
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 0.3 mg/kg
Participants received AIN457 0.3 mg/kg IV on Day 1.
Biological: AIN457
Experimental: AIN457 1.0 mg/kg
Participants received AIN457 1.0 mg/kg IV on Day 1.
Biological: AIN457
Experimental: AIN457 3.0 mg/kg
Participants received AIN457 3.0 mg/kg IV on Day 1.
Biological: AIN457
Placebo Comparator: Placebo
Participants received placebo to AIN457A IV on day 1.
Biological: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 (Investigator Global Assessment) 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 have applied.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770965


Locations
United States, California
Novartis Investigative Site
Santa Monica, California, United States, 90404
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40217
United States, North Carolina
Novartis Investigative Site
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16634
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00770965     History of Changes
Other Study ID Numbers: CAIN457A2204
First Submitted: October 9, 2008
First Posted: October 10, 2008
Results First Submitted: February 2, 2015
Results First Posted: February 18, 2015
Last Update Posted: April 20, 2015
Last Verified: March 2015

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

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