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

NCT ID: NCT00929968

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis

Keywords

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Allergic rhinitis, atopic patients, seasonal allergy, ragweed allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo to VAK694

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

VAK694

Group Type EXPERIMENTAL

VAK694

Intervention Type BIOLOGICAL

Fluticasone propionate

Group Type ACTIVE_COMPARATOR

Fluticasone

Intervention Type DRUG

Interventions

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Placebo

Intervention Type BIOLOGICAL

VAK694

Intervention Type BIOLOGICAL

Fluticasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Novartis Investigative Site

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

Related Links

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

Results for CVAK694A2201 from the Novartis Clinical Trials website

Other Identifiers

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CVAK694A2201

Identifier Type: -

Identifier Source: org_study_id