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

December 11, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Novartis Investigative Site
  • United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo to VAK694
Biological: Placebo
EXPERIMENTAL: VAK694
Biological: VAK694
ACTIVE_COMPARATOR: Fluticasone propionate
Drug: Fluticasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects
Time Frame: 12 weeks
12 weeks
Change in serum levels of total and antigen specific IgE and total and antigen specific IgG
Time Frame: 12 weeks
12 weeks
Immunogenicity of multiple intravenous doses of VAK694
Time Frame: 12 weeks
12 weeks
Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.
Time Frame: 12 weeks
12 weeks
Changes in biomarkers of immunomodulation
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (ESTIMATE)

June 30, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAK694A2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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