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

• ClinicalTrials.gov Identifier: NCT01071252
• Recruitment Status: Completed
• First Posted: February 19, 2010
• Results First Posted: February 16, 2015
• Last Update Posted: February 16, 2015
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Chronic Plaque-type Psoriasis	Drug: AIN457; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: March 2010
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: February 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: AIN457 1x25mg	Drug: AIN457
Experimental: AIN457 3x25mg	Drug: AIN457
Experimental: AIN457 3x75mg	Drug: AIN457
Experimental: AIN457 3x150mg	Drug: AIN457
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 [ Time Frame: 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).

Secondary Outcome Measures :

1. Percentage of Participants With Investigator's Global Assessment (IGA) Response [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]
   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.
2. Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ]
   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).
3. To Assess the Time to Relapse [ Time Frame: 37 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Novartis Investigative Site

San Diego, California, United States, 92123

United States, Kentucky

Novartis Investigative Site

Louisville, Kentucky, United States, 40217

United States, New York

Novartis Investigative Site

Rochester, New York, United States, 14623

United States, Oregon

Novartis Investigative Site

Lake Oswego, Oregon, United States, 97035

Novartis Investigative Site

Portland, Oregon, United States, 97210

Canada, Nova Scotia

Novartis Investigative Site

Halifax, Nova Scotia, Canada, B3H 1Z2

Canada, Ontario

Novartis Investigative Site

North Bay, Ontario, Canada, P1B 3Z7

Novartis Investigative Site

Waterloo, Ontario, Canada, N2J 1C4

Estonia

Novartis Investigative Site

Tallinn, Estonia, 10138

Novartis Investigative Site

Tallinn, Estonia, 13419

Novartis Investigative Site

Tartu, Estonia, 51014

Iceland

Novartis Investigative Site

Kopavogur, Iceland, IS-201

Japan

Novartis Investigative Site

Nagoya-city, Aichi, Japan, 467-8602

Novartis Investigative Site

Maebashi-city, Gunma, Japan, 371-8511

Novartis Investigative Site

Sapporo-city, Hokkaido, Japan, 060-0063

Novartis Investigative Site

Saitama-city, Saitama, Japan, 330-0854

Latvia

Novartis Investigative Site

Riga, Latvia, 1012

Novartis Investigative Site

Riga, Latvia, LV-1001

Novartis Investigative Site

Riga, Latvia

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

Additional Information:

Click here for more information about this study: 

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01071252
• Other Study ID Numbers: CAIN457A2220; 2009-016807-42
• First Posted: February 19, 2010
• Results First Posted: February 16, 2015
• Last Update Posted: February 16, 2015
• Last Verified: February 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Moderate to severe chronic plaque-type psoriasis; AIN457; dermatology

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases