MedPath

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

Phase 1
Withdrawn
Conditions
Asthma
Interventions
Drug: Placebo
Registration Number
NCT00598104
Lead Sponsor
Novartis
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1QAX576-
2Placebo-
Primary Outcome Measures
NameTimeMethod
- Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputumThroughout the study
Secondary Outcome Measures
NameTimeMethod
- Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkersThroughout the study
© Copyright 2025. All Rights Reserved by MedPath