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

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: QAX576

• Registration Number: NCT00584584
• Lead Sponsor: Novartis

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 available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-02
• Primary Completion: 2008-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	QAX576	-

Primary Outcome Measures

Name	Time	Method
Markers of allergic inflammation in the nose measured over 5-8 days post-dose.	throughout the study

Secondary Outcome Measures

Name	Time	Method
- 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.	throughout the study

Trial Locations

Locations (1)

Novartis Investigator Site; 🇬🇧 London, United Kingdom