An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00584584

First received: December 21, 2007

Last updated: September 1, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

September 1, 2010

Start Date ^ICMJE

December 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Markers of allergic inflammation in the nose measured over 5-8 days post-dose. [ Time Frame: throughout the study ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00584584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose. [ Time Frame: throughout the study ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever

Official Title ^ICMJE

A Proof of Concept Study of the Effects of QAX576 (an Interleukin-13 Monoclonal Antibody) on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen

Brief Summary

This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Allergic Rhinitis

Intervention ^ICMJE

Drug: QAX576
Drug: Placebo

Study Arm (s)

Experimental: 1
Intervention: Drug: QAX576
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

History of allergic rhinitis.

Exclusion Criteria:

Respiratory disease other than mild intermittent asthma.
Received immunotherapy in past 3 years.
History of clinically significant drug allergy.
History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.
History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00584584

Other Study ID Numbers ^ICMJE

CQAX576A2104

Has Data Monitoring Committee

Responsible Party

External Affairs, Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

NOVARTIS

Novartis investigator site

Information Provided By

Novartis

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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