Last updated: 11/01/2019 20:30:06
Meta-analysis to further assess the efficacy of mepolizumab 100mg SC on selected endpoints and to further investigate the relationship between efficacy endpoints, blood eosinophils and other important subgroups
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-analysis to further assess the efficacy of mepolizumab 100mg SC on selected endpoints and to further investigate the relationship between efficacy endpoints, blood eosinophils and other important subgroups
Trial description: This is an umbrella study which will cover multiple objectives for pooled analysis of the mepolizumab studies MEA115588 (MENSA) and 200862 (MUSCA) in severe eosinophilic asthma. MEA115588 was a Phase III placebo controlled study which evaluated both 75 mg intravenous (IV) dose and a 100 mg SC dose of mepolizumab given for 32 weeks and 200862 was a Phase IIIb placebo controlled study which evaluated 100 mg SC dose of mepolizumab given for 24 weeks. This analysis will be performed to estimate the effect of mepolizumab 100 mg SC on exacerbation rates and other endpoints in subjects with severe eosinophilic asthma and to further investigate the relationship between efficacy endpoints and blood eosinophils and other important baseline characteristics. Subjects who were randomized to mepolizumab 100 mg SC or placebo across studies MEA115588 and 200862 will be included in the analysis. The effect of the 100 mg SC dose of mepolizumab will be compared to placebo and the estimated treatment differences at the end of study (Week 32 for MEA115588 and Week 24 for 200862) will be combined for each endpoint.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate per year of clinically significant exacerbations
Timeframe: Up to Week 32
Secondary outcomes:
Rate per year of exacerbations requiring ED visit/hospitalization
Timeframe: Up to Week 32
Rate per year of exacerbations requiring hospitalization
Timeframe: Up to Week 32
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Timeframe: Baseline and up to Week 32
Change from baseline in post-bronchodilator FEV1
Timeframe: Baseline and up to Week 32
Change from baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score
Timeframe: Baseline and up to Week 32
Change from baseline in Asthma Control Questionnaire (ACQ-5) Score
Timeframe: Baseline and up to Week 32
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2018-30-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Albers F, Papi A, Taillé C, Bratton D, Bradford E, Yancey S, Kwon N.Mepolizumab reduces exacerbations in patients with severe eosinophilic asthma, irrespective of body weight/body mass index: meta-analysis of MENSA and MUSCA.Respir Res.2019;20(1):169
- Randomized placebo-controlled studies of mepolizumab 100 mg SC dose in severe eosinophilic asthma. Subjects randomized to mepolizumab 100 mg SC or placebo in studies MEA115588 and 200862 will be included in the analysis.
- Study duration should be of at least 24 weeks.
- Subjects from study MEA115588 who were randomized to mepolizumab 75 mg IV will not be included in the analysis.
Inclusion and exclusion criteria
Inclusion criteria:
- Randomized placebo-controlled studies of mepolizumab 100 mg SC dose in severe eosinophilic asthma. Subjects randomized to mepolizumab 100 mg SC or placebo in studies MEA115588 and 200862 will be included in the analysis.
- Study duration should be of at least 24 weeks.
- Studies where maintenance oral corticosteroid use (OCS) was kept constant.
Exclusion criteria:
- Subjects from study MEA115588 who were randomized to mepolizumab 75 mg IV will not be included in the analysis.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-30-11
Actual study completion date
2018-30-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
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Additional information
208115 Full CTR Summary
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