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: March 30, 2015
Last verified: March 2015
  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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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 (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
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: 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

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
Results First Received: February 2, 2015
Last Updated: March 30, 2015
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
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on July 27, 2015