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

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Biological: Placebo; Biological: VAK694; Drug: Fluticasone

• Registration Number: NCT00929968
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Primary Completion: 2011-02
• Status Verified: 2012-05
• Disposition First Submitted: 2012-05-02
• Disposition First Submitted QC: 2012-05-02
• Disposition First Posted: 2012-05-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to VAK694	Placebo	-
VAK694	VAK694	-
Fluticasone propionate	Fluticasone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in serum levels of total and antigen specific IgE and total and antigen specific IgG	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
To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects	12 weeks
Immunogenicity of multiple intravenous doses of VAK694	12 weeks

Trial Locations

Locations (2)

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Novartis Investigative Site; 🇨🇦 Ottawa, Ontario, Canada