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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929968
• Other study ID #: CVAK694A2201
• Status: Completed
• Phase: Phase 2
• Start date: June 2009

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• 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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• Placebo

• VAK694

Drug:
• Fluticasone

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Ottawa	Ontario
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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

External Links

•   Results for CVAK694A2201 from the Novartis Clinical Trials website