Trial Profile
A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps - SYNAPSE (StudY in NAsal Polyps Patients to Assess the Safety and Efficacy of Mepolizumab)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Jan 2025
Price :
$35
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At a glance
- Drugs Mepolizumab (Primary) ; Mometasone
- Indications Nasal polyps; Rhinosinusitis
- Focus Registrational; Therapeutic Use
- Acronyms SYNAPSE
- Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK
Most Recent Events
- 03 Jan 2025 According to GSK media release, company announced that the China National Medical Products Administration has approved Nucala (mepolizumab) for the treatment of adult patients with CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. The approval is based on results of the phase III MERIT trial and is supported by data from the global phase III SYNAPSE study.
- 01 Apr 2023 Results of post hoc analysis assessing treatment responses and association with patient characteristics. The proportion of patients meeting any and each of five response criteria indicating improvement in disease-specific quality of life, NP size, nasal obstruction, loss of smell, and overall symptoms at Weeks 24 and 52, were assessed in subgroups: 1) no surgery; 2) neither surgery nor systemic corticosteroids (SCS) published in the Rhinology
- 27 Feb 2023 Results of post hoc analysis assessing the changes from baseline in peak nasal inspiratory fliw at week 52 and proportions of PRO responders at week 49-52, among patients with greater than equal to 1 point versus no (less than 1 point) week 52 improvemnet in NPS, presented at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.