Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)

Summary

This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS for the purpose of registration in Japan and China. Approximately 160 participants will be randomized in a 1:1 ratio to receive either 100 mg SC mepolizumab or placebo SC. The study will include a 4-week run-in period followed by randomization to a 52-week treatment period, where participants will be administered 4-weekly doses of mepolizumab or placebo via a pre-filled safety syringe device (SSD) injection.

Timeline

Start

2021-04-22

Primary completion

2023-04-12

Completion

2023-04-12

Outcome

Mixed primary results

registry analysis (superiority test); Mepolizumab vs Placebo; p = 0.067; Mean Difference (Final Values) -0.43 (95% CI -0.89 to 0.03) NCT04607005 ↗

registry analysis (superiority test); Mepolizumab vs Placebo; p = 0.043; Mean Difference (Final Values) -0.47 (95% CI -0.92 to -0.02) NCT04607005 ↗

registry analysis (superiority test); Mepolizumab vs Placebo; p = 0.003; Mean Difference (Final Values) -1.43 (95% CI -2.37 to -0.50) NCT04607005 ↗

registry analysis (superiority test); Mepolizumab vs Placebo; p = 0.002; Mean Difference (Final Values) -1.43 (95% CI -2.35 to -0.51) NCT04607005 ↗

Publications

• Background Fujieda S, Wang C, Yoshikawa M, Asako M, Suzaki I, Bachert C, Han JK, Fuller A, Baylis L, Su L, Sasaki E, Sousa AR, Chan R, Zhang L. Mepolizumab in CRSwNP/ECRS and NP: the phase III randomised MERIT trial in Japan, China, and Russia. Rhinology. 2024 Oct 1;62(5):576-589. doi: 10.4193/Rhin24.156.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mepolizumab	Monoclonal antibody	100 mg	Subcutaneous

Indications