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

Novartis Pharmaceuticals35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

PlaceboBIOLOGICAL

VAK694BIOLOGICAL

FluticasoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Novartis Investigative Site

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects

Time frame: 12 weeks

Change in serum levels of total and antigen specific IgE and total and antigen specific IgG

Time frame: 12 weeks

Immunogenicity of multiple intravenous doses of VAK694

Time frame: 12 weeks

Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.

Time frame: 12 weeks

Changes in biomarkers of immunomodulation

Time frame: 12 weeks

Data from ClinicalTrials.gov

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