Asthma Clinical Trial
Official title:
A Multi-centre, Open Label, Single Arm, 32-week Treatment Study in Subjects With Severe Eosinophilic Asthma Not Optimally Controlled With Current Omalizumab Treatment Who Are Switched From Omalizumab to Mepolizumab 100mg Subcutaneous (Study Number 204471- the OSMO Study)
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and
reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE)
monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic
asthma. The aim of this study is to investigate whether subjects not optimally controlled on
their current omalizumab treatment, who are eligible for therapy with mepolizumab can be
effectively and safely switched to treatment with mepolizumab to improve asthma control. The
study will provide data on the efficacy, safety, immunogenicity, and tolerability of
mepolizumab when switched directly from omalizumab without any wash-out. The learnings from
this study may help guide physicians when substituting one biologic with another for the
treatment of patients with severe eosinophilic asthma.
The study will be a multi-centre, open-label single arm trial. Patients with severe
eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be
eligible to participate. Subjects will remain on their current maintenance therapy including
omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit
2 (week 0) subjects will discontinue their omalizumab treatment and be switched to
mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32
weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last
dose of mepolizumab.
n/a
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