Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS) (MERIT)
Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS) (MERIT)
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized in a ratio of 1:1 to receive a single SC dose of 100 mg mepolizumab or placebo every 4 weeks during 52-week treatment period.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The site staff and central study team will be blinded to each participant's eosinophil count (including white blood count differential) and to central overread nasal polyps scores following randomization.
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date: January 28, 2021
Estimated Primary Completion Date: February 6, 2023
Estimated Study Completion Date: February 6, 2023
Arm:
- Experimental: Participants receiving mepolizumab + Standard of care (SoC)
- Placebo Comparator: Participants receiving placebo + SoC
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 160 |
| Estimated Study start date | 28 January 2021 |
| Estimated Study Completion Date | 06 February 2023 |