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

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

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00598104
Enrollment
0
Registered
2008-01-18
Start date
2008-01-31
Completion date
Unknown
Last updated
2016-03-04

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

Conditions

Asthma

Keywords

Asthma, interleukin-13

Brief summary

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

Interventions

DRUGQAX576
DRUGPlacebo

Sponsors

Novartis
Lead SponsorINDUSTRY

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
No

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/

Design outcomes

Primary

MeasureTime frame
- Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputumThroughout the study

Secondary

MeasureTime frame
- Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkersThroughout the study

Outcome results

None listed

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