NCT04607005

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

A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasal Polyps

Interventions

Type	Name	Description
DRUG	Mepolizumab	Mepolizumab will be available as a clear to opalescent, colorless solution for SC injection in a single-use, safety syringe at a unit dose strength of 100 mg/milliliters (mL).
DRUG	Placebo	Placebo will be available as a clear to opalescent, colorless sterile solution for SC injection in a single-use, safety syringe
DRUG	Standard of care	Participants will continue to receive Standard of care as they are used to before entry in the study.

Timeline

• Start date: 2021-04-22
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2020-10-28
• Last updated: 2024-11-25
• Results posted: 2024-11-25

Locations

61 sites across 3 countries: China, Japan, Russia