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: May 31, 2012
Last verified: May 2012
  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:
  • Efficacy of 3 different doses of AIN457 s.c. administered monthly (25 mg, 75 mg and 150 mg) or as a single administration (25 mg) in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement, compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate treatment success as assessed by the Investigator's Global Assessment (static IGA) 12 weeks after start of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of the three different doses administered monthly as well as the single dosing at 12 weeks after start of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess the time to relapse [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
  • To measure the effect of AIN457 on PASI over time [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability [ Time Frame: 37 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: March 2010
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3x150mg Drug: AIN457
Experimental: 3x75mg Drug: AIN457
Experimental: 3x25mg Drug: AIN457
Experimental: 1x25mg 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
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Kentucky
Physician Skin Care
Louisville, Kentucky, United States, 40217
United States, New York
Dermatology Associates of Rochester, P.C.
Rochester, New York, United States, 14623
United States, Oregon
Allergy, Asthma & Dermatology Research Center, LLC
Lake Oswego, Oregon, United States, 97035
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Canada, Nova Scotia
Novartis Investigative site
Halifax, Nova Scotia, Canada
Canada, Ontario
Novartis Investigative site
North Bay, Ontario, Canada
Novartis Investigative site
Waterloo, Ontario, Canada
Estonia
Novartis Investigative site
Talinn, Estonia
Novartis Investigative site
Tallinn, Estonia
Novartis Investigative site
Tartu, Estonia
Iceland
Novartis Investigative Site
Kopavogur, Iceland
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan
Novartis Investigative Site
Maebashi, Gunma, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Saitama, Japan
Latvia
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
Last Updated: May 31, 2012
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

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

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

ClinicalTrials.gov processed this record on October 01, 2014