Back to resultsAn Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QAX576
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinitis, adults, monoclonal antibody, interleukin-13.
Eligibility Criteria
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
Sites / Locations
- Novartis Investigator Site
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
Secondary Outcome Measures
- 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00584584
Brief Title
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic rhinitis, adults, monoclonal antibody, interleukin-13.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
QAX576
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
- 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NOVARTIS
Organizational Affiliation
Novartis investigator site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigator Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212306/
Description
Results of CQAX576A2104 from United European Gastroenterology journal
Learn more about this trial
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
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