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 2

Completed

• Conditions: Chronic Plaque Psoriasis
• Interventions: Biological: AIN457; Biological: Placebo

• Registration Number: NCT00770965
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-10
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Primary Completion: 2009-09-17
• Study Completion: 2009-09-17
• Disposition First Submitted: 2012-05-31
• Disposition First Submitted QC: 2012-05-31
• Disposition First Posted: 2012-06-06
• Results First Submitted: 2015-02-02
• Results First Submitted QC: 2015-02-02
• Results First Posted: 2015-02-18
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIN457 3.0 mg/kg	AIN457	Participants received AIN457 3.0 mg/kg IV on Day 1.
AIN457 0.3 mg/kg	AIN457	Participants received AIN457 0.3 mg/kg IV on Day 1.
AIN457 1.0 mg/kg	AIN457	Participants received AIN457 1.0 mg/kg IV on Day 1.
Placebo	Placebo	Participants received placebo to AIN457A IV on day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores	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

Name	Time	Method
Investigator Global Assessment (IGA) Scores	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.
Change From Baseline in PASI	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Nashville, Tennessee, United States