Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis
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
1 other identifier
interventional
35
2 countries
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedDecember 19, 2020
May 1, 2012
1.7 years
June 29, 2009
December 11, 2020
Conditions
Keywords
Outcome Measures
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
12 weeks
Secondary Outcomes (5)
To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects
12 weeks
Change in serum levels of total and antigen specific IgE and total and antigen specific IgG
12 weeks
Immunogenicity of multiple intravenous doses of VAK694
12 weeks
Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.
12 weeks
Changes in biomarkers of immunomodulation
12 weeks
Study Arms (3)
Placebo to VAK694
PLACEBO COMPARATORVAK694
EXPERIMENTALFluticasone propionate
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Novartis Investigative Site
Ottawa, Ontario, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
June 1, 2009
Primary Completion
February 1, 2011
Last Updated
December 19, 2020
Record last verified: 2012-05