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WithdrawnNCT00598104Updated Mar 4, 2016

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

A Phase 1/2 interventional study of QAX576 and Placebo in Asthma, sponsored by Novartis. Withdrawn. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-03-04.

Sponsored by Novartis · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Due to the lack of enrolment and complexity of design, this study in asthma was terminated. No subjects have been dosed for this study.
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma

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Keywords

  • Asthma, interleukin-13
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

Browse Asthma studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of asthma attacks
  • Taking inhaled corticosteroids
  • Non-smoking

Exclusion criteria

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Drug: QAX576

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugQAX576
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. - 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

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

    Time frame: Throughout the study

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00598104
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Jan 18, 2008
Start date
Jan 2008
Primary completion
Dec 2008
Last update
Mar 4, 2016

Study contacts

NOVARTIS
principal investigator · Novartis investigative site

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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