drugset / Trial / NCT01716754
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2012-12
- Primary completion
- 2016-01
- Completion
- 2016-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ligelizumab | Monoclonal antibody | 12 mg | Subcutaneous |
| Subject | Ligelizumab | Monoclonal antibody | 36 mg | Subcutaneous |
| Subject | Ligelizumab | Monoclonal antibody | 120 mg | Subcutaneous |
| Subject | Ligelizumab | Monoclonal antibody | 180 mg | Subcutaneous |
| Subject | Ligelizumab | Monoclonal antibody | 240 mg | Subcutaneous |
| Comparator | Omalizumab | Monoclonal antibody | — | Subcutaneous |