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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00929968
First received: June 29, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
 Biological: Placebo
Biological: VAK694
Drug: Fluticasone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum levels of total and antigen specific IgE and total and antigen specific IgG [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity of multiple intravenous doses of VAK694 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in biomarkers of immunomodulation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2009
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo to VAK694 Biological: Placebo
Experimental: VAK694 Biological: VAK694
Active Comparator: Fluticasone propionate Drug: Fluticasone

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929968

Locations
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Canada, Ontario
Novartis Investigative Site
Ottawa, Ontario, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00929968     History of Changes
Other Study ID Numbers: CVAK694A2201
Study First Received: June 29, 2009
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Allergic rhinitis,
atopic patients,
seasonal allergy,
ragweed allergy

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013