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

Novartis36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

QAX576DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Investigator Site

Hanover, Germany

Novartis Investigator Site

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: throughout the study

Secondary Outcomes

- 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.