Clinical Trials

Date: 2017-06-27

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: GSK (UK)

Product: mepolizumab

Action mechanism:

monoclonal antibody. Mepolizumab is a targeted anti-IL-5 monoclonal antibody.It binds to the signalling protein IL-5, preventing it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.
Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils.

Disease: severe bilateral nasal polyps

Therapeutic area: Inflammatory diseases

Country:

Trial details:

The pivotal phase III study named SYNAPSE (StudY in NAsal Polyps patients to assess the Safety and Efficacy of mepolizumab) is a 52-week, randomised, double-blind, parallel group study. Throughout the study period, patients will receive standard of care for nasal polyps consisting of daily mometasone furoate nasal spray, and if required, saline nasal douching, occasional short courses of high dose oral corticosteroids and/or antibiotics. Patients with severe bilateral nasal polyps were defined as those with an average nasal obstruction VAS symptom score > 5 and an endoscopic score of at least 5 out of a maximum score of 8, with a minimum score of 2 in each nasal cavity. Patients must also have a history of at least one prior surgery for nasal polyps, have recurrent nasal polyps despite treatment with standard of care and be in need of nasal polyp surgery.

Latest news:

• On June 27, 2017, GSK announced the start of a phase III study with mepolizumab in patients with severe bilateral nasal polyps. The study will assess the efficacy and safety of subcutaneous mepolizumab 100mg compared to placebo, administered using a pre-filled syringe every 4 weeks for 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 (VAS) 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.