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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Biological: Placebo; Biological: AIN457

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Novartis Investigative Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Novartis Investigative Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16634
      • Novartis Investigative Site
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, weeks 12, 14, 16, 20, 24, 28 and 32
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.	baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2008
• Primary Completion (Actual): September 17, 2009
• Study Completion (Actual): September 17, 2009

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (Estimate): October 10, 2008

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Plaque psoriasis, skin condition, thickening, flaking, skin disease, autoimmune disease
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457A2204