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

Novartis

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Biological: Placebo; Biological: VAK694; Drug: Fluticasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929968

CVAK694A2201

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 3 patient groups, including a placebo group

Placebo to VAK694

Placebo Comparator group

Treatment:

Biological: Placebo

VAK694

Experimental group

Treatment:

Biological: VAK694

Fluticasone propionate

Active Comparator group

Treatment:

Drug: Fluticasone