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

This study has been withdrawn prior to enrollment.
(Due to the lack of enrolment and complexity of design, the QAX576A2103 study in asthma was terminated. No subjects have been dosed for this study.)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00598104
First received: January 9, 2008
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Asthma
Drug: QAX576
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo Controlled, Parallel Group, Multi-Center Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Doses of QAX576 in Moderate Persistent Allergic Asthmatics Following Inhaled Corticosteroid Withdrawal

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • - Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: QAX576
Other Name: QAX576
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598104

Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: NOVARTIS Novartis investigative site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00598104     History of Changes
Other Study ID Numbers: CQAX576A2103
Study First Received: January 9, 2008
Last Updated: May 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Asthma, interleukin-13

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014