A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

Status:	Completed
Conditions:	Asthma
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	4/21/2016
Start Date:	January 2012
End Date:	February 2015

A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists

This study is designed to investigate the efficacy and safety of QBX258 in subjects with
moderate to severe asthma.

Inclusion Criteria:

- Patients with atopic asthma >1 year duration diagnosed according to the GINA
guidelines.

- Subjects must weigh at least 50 kg to participate in the study, and must have a body
mass index (BMI) within the range of 18 - 39 kg/m2.

- Asthma which is not adequately controlled on current treatment, as demonstrated by an
Asthma Control Questionnaire (ACQ) score of > 1.5.

- FEV1 40 to 90% of predicted.

Exclusion Criteria:

- Diagnosed with COPD as defined by the GOLD guidelines

- Subjects who have had a respiratory tract infection within 4 weeks prior to
screening.

- Women of child-bearing potential must use highly effective methods of contraception
during dosing and for at least 18 weeks after last study drug administration

We found this trial at

sites

Novartis Investigator Site

Minneapolis, Minnesota 55402

from

Minneapolis, MN