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COSMOS: Long-term Safety of Mepolizumab in Severe Asthma
NCT01842607Phase 3
Key facts
- Status
- Completed
- Start
- May 2013
- Primary completion
- Mar 2015
- Countries
- 19
- Sponsor
- GSK
- Modality
- Monoclonal Antibodies
- Drugs
- mepolizumab
- Conditions
- eosinophilic asthma (EA)
01
Overview
Phase 3, open-label, single-arm trial of mepolizumab in eosinophilic asthma (EA), sponsored by GSK. Primary endpoint: Number of Participants With Adverse Events (AEs) Including Both Systemic and Local Site Reactions at 60 weeks. Started May 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Mepolizumab Arm
Mepolizumab 100 mg SC every 4 weeks
03
Who it enrols
Patients who completed the MEA115588 (MENSA) or MEA115575 (SIRIUS) trials with severe refractory asthma and a history of eosinophilic inflammation.
04
Endpoints
Primary
Number of Participants With Adverse Events (AEs) Including Both Systemic and Local Site Reactions
Secondary
Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies
Annualized Rate of Exacerbations Per Year
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1
Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events
Number of Participants Hospitalized Due to Exacerbations and Adverse Events
Number of Participants With Electrocardiogram (ECG) Findings
Mean Change From Baseline in QTcB and QTcF Values
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