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Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00929968
First received: June 29, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes

June 29, 2009
May 2, 2012
June 2009
February 2011   (final data collection date for primary outcome measure)
To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00929968 on ClinicalTrials.gov Archive Site
  • To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum levels of total and antigen specific IgE and total and antigen specific IgG [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity of multiple intravenous doses of VAK694 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in biomarkers of immunomodulation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis
A Randomized, Double-blind, Placebo and Calibrator Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Doses of VAK694 in Subjects With Seasonal Rhinitis During Natural Exposure to Allergen

This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Allergic Rhinitis
  • Biological: Placebo
  • Biological: VAK694
  • Drug: Fluticasone
  • Placebo Comparator: Placebo to VAK694
    Intervention: Biological: Placebo
  • Experimental: VAK694
    Intervention: Biological: VAK694
  • Active Comparator: Fluticasone propionate
    Intervention: Drug: Fluticasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
Not Provided
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects between ages of 18 to 60 in good health
  • History of atopy for at least 2 years and positive skin prick test to ragweed allergen

Exclusion criteria:

  • History of asthma treated with corticosteroids
  • Smokers with a smoking history of > 10 pack/years or smoking in the past year
  • History of chronic obstructive pulmonary disease

Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00929968
CVAK694A2201
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP