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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01071252
First received: February 18, 2010
Last updated: February 12, 2015
Last verified: February 2015
  Purpose

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 Intervention Phase
Chronic Plaque-type Psoriasis
Drug: AIN457
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 [ Time Frame: week 13 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants With Investigator's Global Assessment (IGA) Response [ Time Frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • To Assess the Time to Relapse [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 125
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071252

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:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01071252     History of Changes
Other Study ID Numbers: CAIN457A2220, 2009-016807-42
Study First Received: February 18, 2010
Results First Received: January 28, 2015
Last Updated: February 12, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Iceland: Icelandic Medicines Control Agency
Estonia: The State Agency of Medicine
Latvia: Agency of Medicines
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Moderate to severe chronic plaque-type psoriasis
AIN457
dermatology

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 03, 2015