Mepolizumab(SB-240563) in Severe Bilateral Nasal Polyposis

• Research type

  Research Study

• Full title

  A TWO-PART, RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTI-CENTER STUDY TO INVESTIGATE THE USE OF MEPOLIZUMAB (SB-240563) IN REDUCING THE NEED FOR SURGERY IN SUBJECTS WITH SEVERE BILATERAL NASAL POLYPOSIS

• IRAS ID

  10808

• Contact name

  Valarie Lund

• Eudract number

  2008-003772-21

• ISRCTN Number

  ISRCTN

• Clinicaltrials.gov Identifier

  NCT

• Research summary

  Mepolizumab is being investigated as a treatment for reducing the need for surgery in patients with severe bilateral nasal polyposis. Nasal polyposis has long been known as chronic inflammatory disease of the nasal mucosa and is characterized by the presence of polyps in the upper nasal cavity, originating from within the ostiomeatal complex. Eosinophils are the most common infiltrating inflammatory cells in nasal polyps. Interleukin-3 (IL-3), Interleukin-5 (IL-5) and Granulocyte-macrophage colony stimulating factor (GMCSF) are involved in regulating eosinophil development. Of these, IL-5 is the most specific to eosinophils. Mepolizumab is a fully humanized monoclonal antibody which is specific for human interleukin-5 (IL-5). The purpose of this current study is to explore further the effect of Mepolizumab on nasal polyp size and also its ability to reduce the need for polyp surgery.

• REC name

  London - Central Research Ethics Committee

• REC reference

  09/H0718/19

• Date of REC Opinion

  4 Jun 2009

• REC opinion

  Further Information Favourable Opinion