Last updated: 11/01/2019 20:40:04
Meta-analysis to further assess the efficacy of mepolizumab 100mg subcutaneous dose on selected endpoints in subjects eligible for omalizumab treatment and other related 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 subcutaneous dose on selected endpoints in subjects eligible for omalizumab treatment and other related subgroups
Trial description: This is an umbrella study covering pooled analysis of the two mepolizumab studies; MEA115588 (MENSA) and 200862 (MUSCA) in subjects with severe eosinophilic asthma. This analysis will be performed to estimate the effect of mepolizumab on exacerbation rates and other endpoints in subjects eligible for/previously exposed to omalizumab treatment. The endpoints will be further analyzed in the omalizumab-related subgroups. MEA115588 (MENSA) was a phase III, placebo controlled study which evaluated both a 75 mg intravenous (IV) dose and a 100 mg SC dose given for 32 weeks and 200862 (MUSCA) was a phase IIIb, placebo controlled study which evaluated 100 mg SC dose given for 24 weeks. This meta-analysis will compare the effect of mepolizumab 100 mg SC dose to placebo, in subjects who were previously randomized to mepolizumab 100 mg SC or placebo across MENSA and MUSCA studies.
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 1 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
Change from Baseline in blood eosinophils
Timeframe: Baseline and up to Week 32
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2018-30-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Humbert M, Albers FC, Bratton D, Yancey SW, Liu M, Hozawa S, Llanos JP, Kwon N. Effect of mepolizumab in severe eosinophilic asthma according to omalizumab eligibility. Respir Med. 2019;154:69-75
DOI: 10.1016/j.rmed.2019.06.004
PMID: 31220806
Medical condition
Asthma
Product
mepolizumab, omalizumab
Collaborators
Not applicable
Study date(s)
November 2017 to November 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
Not applicable
- Randomized placebo-controlled studies of mepolizumab 100mg SC dose in severe eosinophilic asthma.
- Duration 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 100mg SC dose in severe eosinophilic asthma.
- Duration of at least 24 weeks.
- Studies where maintenance oral corticosteroid use (OCS) was kept constant.
- Subjects with severe eosinophilic asthma who are eligible for/previously exposed to omalizumab treatment.
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
Not applicable
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