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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

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AIN457
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AIN457 0.3 mg/kg

AIN457 1.0 mg/kg

AIN457 3.0 mg/kg

Placebo

Arm Description

Participants received AIN457 0.3 mg/kg IV on Day 1.

Participants received AIN457 1.0 mg/kg IV on Day 1.

Participants received AIN457 3.0 mg/kg IV on Day 1.

Participants received placebo to AIN457A IV on day 1.

Outcomes

Primary Outcome Measures

Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
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
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
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.

Full Information

First Posted
October 9, 2008
Last Updated
February 12, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00770965
Brief Title
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 10, 2008 (Actual)
Primary Completion Date
September 17, 2009 (Actual)
Study Completion Date
September 17, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457 0.3 mg/kg
Arm Type
Experimental
Arm Description
Participants received AIN457 0.3 mg/kg IV on Day 1.
Arm Title
AIN457 1.0 mg/kg
Arm Type
Experimental
Arm Description
Participants received AIN457 1.0 mg/kg IV on Day 1.
Arm Title
AIN457 3.0 mg/kg
Arm Type
Experimental
Arm Description
Participants received AIN457 3.0 mg/kg IV on Day 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo to AIN457A IV on day 1.
Intervention Type
Biological
Intervention Name(s)
AIN457
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Description
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.
Time Frame
baseline, week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in PASI
Description
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.
Time Frame
baseline, weeks 12, 14, 16, 20, 24, 28 and 32
Title
Investigator Global Assessment (IGA) Scores
Description
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.
Time Frame
baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion: Coverage of the body surface area (BSA) of 10% or more with plaques A score of 3 or more on the IGA (Investigator Global Assessment) scale 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Novartis Investigative Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Novartis Investigative Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16634
Country
United States
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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