Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Omalizumab

Criteria

Key Inclusion Criteria:

• A diagnosis of allergic asthma , uncontrolled on current medication.

• History of at least 1 asthma exacerbation during the last 1 year

• Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).

Key Exclusion Criteria:

• Baseline IgE levels or body weight outside the omalizumab dosing table.

• Use of tobacco products within the previous 6 months (Social occasional smokers may be included).

• Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.