AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00941031
First received: July 16, 2009
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, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding 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:
  • To evaluate the efficacy of three induction regimens of AIN457 administered subcutaneously in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement after 12 weeks of treatment, compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the efficacy of two maintenance regimens of AIN457 with respect to PASI 75 achievement at least once from week 21 to 29 [ Time Frame: week 21 to 29 ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of three induction regimens of AIN457 administered subcutaneously with respect to IGA 0 or 1 achievement after 12 weeks of treatment, compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 404
Study Start Date: July 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Drug: AIN457
Experimental: Monthly Drug: AIN457
Experimental: Early 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:

  • Men or women at least 18 years of age at time of consent
  • Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
  • At time of 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 and/or
    • phototherapy and/or
    • previous systemic therapy

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from entry into the study:

  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
  • Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization
  • Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to
  • Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration
  • Known immunosuppression (e.g., AIDS) at screening and / or randomization
  • History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
  • Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)
  • At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
  • History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization
  • History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization
  • Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941031

  Show 69 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00941031     History of Changes
Other Study ID Numbers: CAIN457A2211, EudraCT 2008-007525-39
Study First Received: July 16, 2009
Last Updated: May 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Iceland: Icelandic Medicines Control Agency
Israel: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Norway: Norwegian Medicines Agency
United States: Food and Drug Administration

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 April 16, 2014