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

NCT04607005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2024-11-25

Study results available
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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

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.

Sponsors & Collaborators

  • BioClinica, Inc.

    collaborator INDUSTRY

  • Signant Health

    collaborator OTHER

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2023-04-12
Completion
2023-04-12

Countries

  • China
  • Japan
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607005 on ClinicalTrials.gov