Hypereosinophilic Syndrome Clinical Trial
Official title:
A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms
which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells,
various end-organ damages (including skin, heart, lung, nervous system and digestive system
etc.), and with exclusion of known secondary causes of hypereosinophilia.
HES has a high morbidity/mortality rate. The major treatment of HES has been systemic
corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon)
with the intention to lower eosinophil counts and therefore to slow down the progression of
disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia
in some patients, some may eventually become nonresponsive and intolerable to the amount of
side effects of the long-term therapy with these medications.
Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5
(hIL-5) and inhibits its activity. Previous human experience has shown it has been effective
in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES
clinical signs and symptoms. This study intends to further evaluate the
corticosteroid-sparing and clinical benefit of mepolizumab in HES.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously in Subjects with Hypereosinophilic Syndromes (HES) and to evaluate the Efficacy and Safety of Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months ;
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