Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

Summary

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Timeline

Start

2007-07

Primary completion

2008-09

Completion

2008-09

Publications

• Somerville L, Bardelas J, Viegas A, D'Andrea P, Blogg M, Peachey G. Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2014 Jan;30(1):59-66. doi: 10.1185/03007995.2013.844115. Epub 2013 Oct 1.

Drugs

Indications