GSK starts mepolizumab study in patients with nasal polyps

Amy Schofield 29 June 2017

GSK has announced the start of a phase III study with mepolizumab, an interleukin 5 (IL-5) antagonist, in patients with severe bilateral nasal polyps.

Nasal polyps is a chronic inflammatory disease of the nasal passage linings or sinuses leading to soft tissue growth in the upper nasal cavity.

The current standard of care is treatment with intranasal corticosteroids and, for severe cases, oral corticosteroids. Surgery to remove the polyp tissue may also be indicated for severe cases, however polyps have a strong tendency to reoccur often requiring repeat surgery. 

The study will assess the efficacy and safety of subcutaneous mepolizumab 100mg compared to placebo, administered using a pre-filled syringe every four weeks over 52 weeks, on top of standard of care in 400 adult patients with recurrent severe bilateral nasal polyps.

The co-primary endpoint of the study is the change from baseline in the total nasal polyps score (sum of left and right nostril score) assessed by endoscopy at week 52 and nasal obstruction, as measured using the visual analogue scale symptom score during the four weeks prior to week 52. The key secondary endpoint is the time to first actual surgery for nasal polyps by week 52. The study is anticipated to complete in 2019.

Steve Yancey, Vice President and Medicine Development Leader for mepolizumab, said: “Our aim is to see whether mepolizumab can improve symptoms, reduce nasal polyp size and reduce the need for surgery in these patients despite optimal medical management.”

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