Efficacy of QAX576 in Asthma

A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130064

Enrollment

259

Registered

2010-05-25

Start date

2010-05-31

Completion date

2012-04-30

Last updated

2020-12-19

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

Conditions

Asthma

Keywords

Asthma, QAX576

Brief summary

The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.

Interventions

BIOLOGICALQAX576

every 3 weeks via intravenous infusion

DRUGPlacebo

every 3 weeks via intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male and female patients * Female patients must be surgically sterilized or postmenopausal * Male patients must use two forms of contraception * Body mass index must be between 18 and 39 kg/m2 * Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists

Exclusion criteria

* Smoking history \>10 pack-years * Patients with a diagnosis of chronic obstructive pulmonary disease (COPD) * Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening * Patients who have had a respiratory tract infection within 6 weeks prior to screening * History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study

Design outcomes

Primary

Measure	Time frame
Asthma Control Questionnaire	24 weeks

Secondary

Measure	Time frame
Incidence rate of clinically significant asthma exacerbations	24 weeks

Countries

Argentina, Belgium, Czechia, Germany, Poland, Russia, United States

Outcome results

None listed

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