Brief Title
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
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
Brief Summary
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.
Detailed 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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Proportion of subjects who achieve a total daily prednisone dose of
Secondary Outcome
Assess the effect of mepo in lowering prednisone dose and blood eosinophil count, improving HES-associated skin manifestations, improving quality of life (QoL), safety and tolerability.
Condition
Hypereosinophilia
Intervention
mepolizumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
86
Start Date
March 23, 2004
Completion Date
May 1, 2006
Primary Completion Date
May 1, 2006
Eligibility Criteria
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:
- Churg-Strauss Syndrome
- Wegener's Granulomatosis
- Lymphoma, hematological malignancy, advanced and metastatic solid tumors
- Chemotherapy, radiotherapy or interleukin 2 treatment.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
GSK Clinical Trials, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00086658
Organization ID
100185
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
May 2020