drugset / Trial / NCT01362244
Mepolizumab in Nasal Polyposis
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2009-05-12
- Primary completion
- 2014-12-05
- Completion
- 2014-12-05
Outcome
Met primary endpoint
registry analysis (unspecified test); Mepolizumab 750 mg vs Placebo; p = 0.003; Fisher Exact NCT01362244 ↗
registry analysis (unspecified test); Mepolizumab 750 mg vs Placebo; p = 0.016; Fisher Exact NCT01362244 ↗
Publications
- Background Bachert C, Sousa AR, Lund VJ, Scadding GK, Gevaert P, Nasser S, Durham SR, Cornet ME, Kariyawasam HH, Gilbert J, Austin D, Maxwell AC, Marshall RP, Fokkens WJ. Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial. J Allergy Clin Immunol. 2017 Oct;140(4):1024-1031.e14. doi: 10.1016/j.jaci.2017.05.044. Epub 2017 Jul 4.
- Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mepolizumab | Monoclonal antibody | 750 mg | Intravenous |