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Completed

NCT Number: NCT00584584

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

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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigator Site, Hanover, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QAX576

Drug

Placebo

Drug

Primary outcomes

  1. Markers of allergic inflammation in the nose measured over 5-8 days post-dose.

    Time frame: throughout the study

Secondary outcomes

  1. - 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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
First posted
Jan 2, 2008
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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