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Mepolizumab Long-term Safety Study in Asthma (MEA115666)
NCT01691859Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2012
- Primary completion
- May 2017
- Countries
- 13
- Sponsor
- GSK
- Modality
- Monoclonal Antibodies
- Drugs
- mepolizumab
- Conditions
- asthma
01
Overview
Phase 3, open-label, single-arm trial of mepolizumab in asthma, sponsored by GSK. Primary endpoints: On-treatment Adverse Events at 240 weeks and On-treatment Serious Adverse Events at 240 weeks. Started Sep 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Mepolizumab Arm
Subjects receive 100 mg mepolizumab SC every 4 weeks.
03
Who it enrols
Subjects who participated in the MEA112997 trial and received at least 2 doses of investigational product, currently treated with a controller medication for at least 12 weeks.
04
Endpoints
Primary
On-treatment Adverse Events
On-treatment Serious Adverse Events
Secondary
On-treatment Systemic and Local Site Reactions
QT Interval Corrected by Bazett's Method
QT Interval Corrected by Fridericia's Method
Annualized Rate of On-treatment Exacerbations
Asthma Control Questionnaire
Pre-bronchodilator Forced Expiratory Volume in 1 Second
Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies
Number of Participants Who Withdrew Due to Lack of Efficacy
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