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A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma

NCT03562195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-09-19

Study results available
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Summary

Mepolizumab, a humanized monoclonal antibody, has been developed as an add-on treatment for subjects with severe asthma with eosinophilic inflammation. Current asthma treatment guidelines offer minimal options for the severe asthmatic subjects on intensive therapy with frequent exacerbations. There is a significant unmet medical need to provide better treatment options for this segment of the asthma population. Thus, this study is designed to evaluate the efficacy and safety of mepolizumab in Chinese severe asthmatic subjects with eosinophilic inflammation. A total number of 300 subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy. The maximum study duration will be 56 weeks.

Conditions

Interventions

DRUG

Mepolizumab 100 milligrams

Mepolizumab will be given as a lyophilized cake in sterile vials for individual use. The vial will be reconstituted with Sterile Water for Injection, just prior to use.

DRUG

Placebo

Placebo will be given as 0.9 percent sodium chloride solution.

DRUG

Salbutamol

Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2022-09-07
Completion
2022-09-07

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
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 NCT03562195 on ClinicalTrials.gov