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Monoclonal Antibodies

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

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8, 16, 24, 32, 40, 48 and week 52
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Prophylaxis of Nasal Polyps
  • Nasal Polyps

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8, 16, 24, 32, 40, 48 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8, 16, 24, 32, 40, 48 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population
Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population
+1 more
Secondary study objectives
Change From Baseline in Mean Individual VAS Symptom Score for Loss of Smell During the 4 Weeks Prior to Week 52 - ITT Population
Mean Change From Baseline in LMK CT Score at Week 52 - ITT Population
Mean Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
+9 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving mepolizumab + Standard of care (SoC)Experimental Treatment2 Interventions
Participants will receive one dose of 100 mg mepolizumab SC on top of SoC every 4 weeks during the 52-week treatment period.
Group II: Participants receiving placebo + SoCPlacebo Group2 Interventions
Participants will receive one dose of placebo via SC route on top of SoC, every 4 weeks during the 52-week treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of care
2020
Completed Phase 4
~17710
Mepolizumab
2020
Completed Phase 4
~5010

Find a Location

Who is running the clinical trial?

Signant HealthUNKNOWN
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,401 Total Patients Enrolled
BioClinica, Inc.Industry Sponsor
7 Previous Clinical Trials
2,849 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,145,295 Total Patients Enrolled
~37 spots leftby Dec 2025
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