A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Chronic Plaque-type Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071252
• Other study ID #: CAIN457A2220
• Secondary ID: 2009-016807-42
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2010
• Last updated: February 12, 2015
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIceland: Icelandic Medicines Control AgencyEstonia: The State Agency of MedicineLatvia: Agency of MedicinesJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

At randomization, moderate to severe psoriasis as defined by:

• PASI score of 12 or greater and,

• IGA score of 3 or greater and,

• Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.

Exclusion Criteria:

• Forms of psoriasis other than chronic plaque-type

• Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization

• Previous exposure to AIN457

• Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to

• Known immunosuppression (e.g., AIDS) at screening and / or randomization

• History or evidence of active tuberculosis at screening

• Active systemic infections (other than common cold)

• History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.

• Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study

• Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study

• Inability or unwillingness to undergo repeated venipuntures

• History or evidence of drug or alcohol abuse

• Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• AIN457

• Placebo

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	North Bay	Ontario
Canada	Novartis Investigative Site	Waterloo	Ontario
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Iceland	Novartis Investigative Site	Kopavogur
Japan	Novartis Investigative Site	Maebashi-city	Gunma
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Saitama-city	Saitama
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
United States	Novartis Investigative Site	Lake Oswego	Oregon
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Estonia,  Iceland,  Japan,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).	week 13	No
Secondary	Percentage of Participants With Investigator's Global Assessment (IGA) Response	IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.	Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37	No
Secondary	Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).	Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37	No
Secondary	To Assess the Time to Relapse	Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.	37 weeks	No

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