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

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

VAK694

Fluticasone

About this trial

This is an interventional prevention trial for Allergic Rhinitis focused on measuring Allergic rhinitis,, atopic patients,, seasonal allergy,, ragweed allergy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Altoona Center for Clinical Research
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo to VAK694

VAK694

Fluticasone propionate

Arm Description

Outcomes

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

Secondary Outcome Measures

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

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

Immunogenicity of multiple intravenous doses of VAK694

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

Changes in biomarkers of immunomodulation

Full Information

NCT ID

NCT00929968

First Posted

June 29, 2009

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00929968

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic rhinitis,, atopic patients,, seasonal allergy,, ragweed allergy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo to VAK694

Arm Type

Placebo Comparator

Arm Title

VAK694

Arm Type

Experimental

Arm Title

Fluticasone propionate

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Type

Biological

Intervention Name(s)

VAK694

Intervention Type

Drug

Intervention Name(s)

Fluticasone

Primary Outcome Measure Information:

Title

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

Immunogenicity of multiple intravenous doses of VAK694

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

Changes in biomarkers of immunomodulation

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6443

Description

Results for CVAK694A2201 from the Novartis Clinical Trials website

Learn more about this trial

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

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