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

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

Participants of 18 years of age and older inclusive, at the time of signing the informed consent.

Body weight greater than or equal to 40 kilograms (kg).

Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study.

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Treatment Details

Interventions

Mepolizumab (Monoclonal Antibodies)

Participant Groups

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.

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Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

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