← Back to Search

Subjects receiving Mepolizumab for Asthma

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Number of clinically significant exacerbations of asthma
Secondary study objectives
Change from Baseline in blood eosinophil ratio
Mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) at Week 52
Mean change from Baseline in clinic prebronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Subjects receiving MepolizumabExperimental Treatment2 Interventions
Eligible subjects will randomized in 1:1 ratio to Mepolizumab group or Placebo group. Subjects in Mepolizumab group will receive Mepolizumab 100mg subcutaneously into the upper arm or thigh every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC of asthma treatment. Subjects will be provided with salbutamol MDIs as a rescue medication to be used on an needed basis in this study.
Group II: Subjects receiving PlaceboPlacebo Group2 Interventions
Eligible subjects in placebo group will receive placebo (0.9 percent sodium chloride) matching to Mepolizumab administered subcutaneously into the upper arm or thigh every 4 weeks during the total treatment period of 52 weeks in addition to their baseline SOC of asthma treatment. Subjects will be provided with salbutamol MDIs as a rescue medication to be used on an as needed basis in this study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salbutamol
1998
Completed Phase 4
~3890
Mepolizumab 100 milligrams
2018
Completed Phase 3
~300

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,176,507 Total Patients Enrolled
300 Trials studying Asthma
500,232 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,144,714 Total Patients Enrolled
229 Trials studying Asthma
401,950 Patients Enrolled for Asthma
~43 spots leftby Sep 2025