Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma

Novartis

Overview

This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Asthma

Interventions

QAX576DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of asthma attacks * Taking inhaled corticosteroids * Non-smoking Exclusion Criteria: * Women of child-bearing potential * History of respiratory disease other than asthma * History of severe allergy to food or drugs * Previous use of monoclonal antibodies * Very low or high body weight Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

- Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum

Time frame: Throughout the study

Secondary Outcomes

- Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers

Time frame: Throughout the study

Data from ClinicalTrials.gov

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