This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic baseline standard of care (SoC) asthma treatment.
Eligible patients
This clinical research study is for participants 12 years and older with asthma who are already receiving mepolizumab or benralizumab. For Germany, UK, and Norway only, adult participants (≥18 years) are to be included in this clinical trial, and ≥16 years in Austria.
The agent
Depemokimab is a humanized anti-interleukin (IL)-5 monoclonal antibody (mAb) engineered for extended half-life and improved IL-5 affinity vs other anti-IL-5, supporting less frequent dosing vs other anti-IL-5 mAbs. Depemokimab blocks IL-5, an important mediator in asthma, from binding to IL-5 receptor alpha-chain on the eosinophil surface.
It is anticipated that receiving Depemokimab every 26 weeks will control asthma equally to mepolizumab or benralizumab.
Safety status
Independent Data Monitoring Committee (IDMC) reviews unblinded data across the four studies in the asthma program periodically:
-Five IDMC meetings for the asthma program to date
-IDMC recommendations have been to continue without changes
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