Efficacy of QAX576 in Asthma

Novartis

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Biological: QAX576

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01130064

CQAX576A2207

2009-011590-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

259 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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