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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

December 21, 2007
September 1, 2010
December 2007
August 2008   (final data collection date for primary outcome measure)
Markers of allergic inflammation in the nose measured over 5-8 days post-dose. [ Time Frame: throughout the study ]
Same as current
Complete list of historical versions of study NCT00584584 on ClinicalTrials.gov Archive Site
- 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 ]
Same as current
Not Provided
Not Provided
 
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Rhinitis
  • Drug: QAX576
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: QAX576
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
August 2008   (final data collection date for primary outcome measure)

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

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT00584584
CQAX576A2104
No
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: NOVARTIS Novartis investigator site
Novartis
September 2010

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