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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00584584

Enrollment

Registered

2008-01-02

Start date

2007-12-31

Completion date

Unknown

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis, adults, monoclonal antibody, interleukin-13.

Brief summary

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

Interventions

DRUGQAX576

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
- 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

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026