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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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