Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hypereosinophilic Syndrome

Hypereosinophilia

Treatments

Drug: mepolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00086658

100185

Details and patient eligibility

About

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.

Full description

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

Enrollment

86 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented history of Hypereosinophilic Syndrome (HES)
Eosinophil count greater than 1500 cells for 6 months
Signs and symptoms of organ system involvement
No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.
Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.
Not pregnant or nursing.

Exclusion criteria