Allergic Rhinitis Clinical Trial
Official title:
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
NCT number | NCT00929968 |
Other study ID # | CVAK694A2201 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2009 |
Verified date | May 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 35 |
Est. completion date | |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Novartis Investigative Site | Ottawa | Ontario |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 weeks | ||
Secondary | To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects | 12 weeks | ||
Secondary | Change in serum levels of total and antigen specific IgE and total and antigen specific IgG | 12 weeks | ||
Secondary | Immunogenicity of multiple intravenous doses of VAK694 | 12 weeks | ||
Secondary | Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season. | 12 weeks | ||
Secondary | Changes in biomarkers of immunomodulation | 12 weeks |
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