Mepolizumab in Nasal Polyposis
Condition: Nasal Polyps
MeSH terms: Nasal Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      A two-part, randomised, double-blind, placebo controlled, multi-centre study to investigate
      the use of mepolizumab (SB-240563) in reducing the need for surgery in subjects with severe
      bilateral nasal polyposis.
    

Detailed description: 
      Nasal polyposis has long been known as chronic inflammatory disease of the nasal mucosa. This
      disease is characterized by the presence of polyps in the upper nasal cavity, originating
      from within the ostiomeatal complex. The presence of polyps can cause long-term symptoms such
      as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge. These symptoms
      can impact greatly upon a patient's quality of life.The etiology of nasal polyposis is
      currently unknown.

      The aim of this present study is to investigate the use of mepolizumab in reducing the
      potential need for surgery in subjects with severe bilateral nasal polyposis. The study is
      split into two parts: Part A is the treatment phase and focuses on the reduction of the need
      for surgery by exploring the efficacy of six doses of mepolizumab (one dose every four weeks)
      on nasal polyposis. This dosing regime will build upon the previous PoC study by exploring
      the potential for increased clinical efficacy as assessed by the potential need for surgery,
      and also and increased duration of action as assessed by time to relapse. Part B is the
      follow-up phase and will assess post-treatment nasal polyposis dynamics with a focus on time
      to relapse. All subjects participating in this study will undergo a run-in period on a low
      dose of intranasal steroids (INS) prior to first dosing. INS will be continued throughout the
      study up until study exit. This is to reflect the real life circumstances in which
      mepolizumab is intended to be used as a therapy. The overall aim of the study design is to
      further assess the impact in the potential need for surgery and explore an appropriate
      mepolizumab therapeutic regimen strategy for the treatment of nasal polyposis.

      In this study, the assessment of nasal polyposis will be performed by means of combining
      endoscopic polyp score with subject reported symptoms. This approach reflects real-life
      clinical assessment of nasal polyposis. Also, this study incorporates condition specific and
      general medical questionnaires in order to obtain a better understanding of the impact of
      severe nasal polyposis of the subject's quality of life (QOL). This is in line with
      increasing focus in the medical field on the effects of medical conditions and treatments on
      the quality of life of patients (Fokkens et al 2007).
    

Intervention name(s): Mepolizumab; Placebo; Run In Medication
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750 mg of mepolizumab by IV infusion; Placebo by IV infusion; subjects will undergo a run-in period of 10 - 14 days on a low dose of Intranasal Steroids (INS).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Quality of Life; Intranasal Steroids; Severe Nasal Polyposis; Polyp Relapse; Endoscopic Polyp Score; Surgery