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

Chronic Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770965
• Other study ID #: CAIN457A2204
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2008
• Last updated: February 12, 2018
• Start date: September 10, 2008
• Est. completion date: September 17, 2009

Study information

• Verified date: February 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 17, 2009
• Est. primary completion date: September 17, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• AIN457

• Placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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