Allergic Rhinitis
Conditions
Keywords
Allergic rhinitis,, atopic patients,, seasonal allergy,, ragweed allergy
Brief summary
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
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects | 12 weeks |
| Change in serum levels of total and antigen specific IgE and total and antigen specific IgG | 12 weeks |
| Immunogenicity of multiple intravenous doses of VAK694 | 12 weeks |
| Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season. | 12 weeks |
| Changes in biomarkers of immunomodulation | 12 weeks |
Countries
Canada, United States
Outcome results
None listed