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Mepolizumab cessation vs continuation in severe eosinophilic asthma
NCT02555371Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2016
- Primary completion
- Jul 2019
- Countries
- 14
- Sponsor
- GSK
- Modality
- Monoclonal Antibodies
- Drugs
- mepolizumab
- Conditions
- severe eosinophilic asthma (SEA)
01
Overview
Phase 3, randomised, double-blind trial of mepolizumab in severe eosinophilic asthma (SEA), sponsored by GSK. Started Jan 2016; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Patients with severe eosinophilic asthma who have received at least 3 years of mepolizumab treatment and are on stable asthma controller therapy.
04
Results
Primary endpoints met
05
Registry description
Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be…
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