Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00805480
First received: December 5, 2008
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: AIN457
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To compare the change from baseline in Psoriasis Area and Severity Index (PASI) scores between the placebo and each of the three loading dose regimens of AIN457. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • To compare the proportion of patients who have not relapsed at any time in the trial between each of the three loading dose regimens of AIN457 [ Time Frame: Duration of trial (56 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the proportion of patients achieving at least 50% improvement as measured by PASI from the baseline visit [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]
  • To evaluate the proportion of patients achieving at least 75% and 90% improvement as measured by PASI from the baseline visit [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]
  • o evaluate the response as measured by Investigator Global Assessment (IGA) scores [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: December 2008
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1 - 1 x 3mg/kg
Drug: AIN457
Dose 1
Experimental: 2
Arm 2 - 1 x 10 mg/kg
Drug: AIN457
Dose 2
Experimental: 3
Arm 3 - 3 x 10 mg/kg
Drug: AIN457
Dose 3
Placebo Comparator: 4 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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: NCT00805480

Locations
United States, Alabama
Novartis Investigator Site
Anniston, Alabama, United States, 36207
United States, California
Novartis Investigator Site
Santa Monica, California, United States, 90404
United States, Florida
Novartis Investigator Site
Port Orange, Florida, United States, 32127
United States, New York
Novartis Investigator Site
Rochester, New York, United States, 14623
United States, Oklahoma
Novartis Investigator Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Novartis Investigator Site
Portland, Oregon, United States, 97223-6683
Canada, New Brunswick
Novartis Investigator Site
Moncton, New Brunswick, Canada
Canada
Novartis Investigator Site
Ontario, Canada
Novartis Investigator Site
Quebec, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Novartis Novartis Investigator Site
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00805480     History of Changes
Other Study ID Numbers: CAIN457A2212
Study First Received: December 5, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Plaque
psoriasis
inflammatory skin disease
skin condition, thickening
flaking
scaly patches
kin disease

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

ClinicalTrials.gov processed this record on July 26, 2014