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NCT Number: NCT00929968

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

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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Biological

VAK694

Biological

Fluticasone

Drug

Primary outcomes

  1. 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

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  3. Immunogenicity of multiple intravenous doses of VAK694

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  5. Changes in biomarkers of immunomodulation

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
First posted
Jun 30, 2009
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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