GB29260 - Lebrikizumab in patients with uncontrolled asthma.

• Research type

  Research Study

• Full title

  A Phase II, Randomised, Double-Blind, Placebo-Controlled bronchoscopy study to evaluate the effects of Lebrikizumab on airway eosinophilic inflammation in patients with uncontrolled asthma on inhaled corticosteroids and a second controller medication.

• IRAS ID

  153275

• Contact name

  Liam Heaney

• Contact email

  l.heaney@qub.ac.uk

• Sponsor organisation

  Genentech Inc.

• Eudract number

  2014-000275-14

• Research summary

  Lebrikizumab is an antibody that attaches to another protein called IL-13. Many doctors believe IL-13 plays an important part in causing asthma. Lebrikizumab prevents IL-13 from interacting with other proteins it normally attaches to, thus preventing the actions of IL-13 in the lungs. Lebrikizumab is a liquid that is injected under the skin. This type of injection is known as a subcutaneous injection. After it is injected, lebrikizumab attaches to and blocks the actions of IL 13. Blocking IL-13 in the lung might help to reduce asthma exacerbations and improve lung function in patients with asthma, but this is unknown at this time.
  In this study, we will examine whether or not lebrikizumab reduces the number of white blood cells called eosinophils in the lungs. Eosinophils are a type of body cell that doctors believe plays a part in asthma. The number of eosinophils in the bronchial tubes (also called airways) will be measured in small samples of the lining of the airway in the lungs that will be taken at two separate procedures with the use of a small telescope (called a bronchoscope) during the study. This procedure is called bronchoscopy. We also hope to learn what lebrikizumab treatment does to other lung and blood measures that may play a role in asthma. Additionally, we will be testing whether lebrikizumab treatment improves lung function, symptoms, and asthma exacerbations that may be experienced during the study.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  14/NE/1072

• Date of REC Opinion

  17 Oct 2014

• REC opinion

  Further Information Favourable Opinion