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

NCT ID: NCT00584584

Last Updated: 2017-02-24

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

QAX576

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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QAX576

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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NOVARTIS

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

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Novartis Investigator Site

Hanover, , Germany

Site Status

Novartis Investigator Site

London, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212306/

Results of CQAX576A2104 from United European Gastroenterology journal

Other Identifiers

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CQAX576A2104

Identifier Type: -

Identifier Source: org_study_id

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