Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086658
Recruitment Status : Completed
First Posted : July 9, 2004
Last Update Posted : April 17, 2015
Information provided by (Responsible Party):

July 7, 2004
July 9, 2004
April 17, 2015
March 2004
May 2006   (Final data collection date for primary outcome measure)
Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks
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Complete list of historical versions of study NCT00086658 on Archive Site
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.
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Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Hypereosinophilia
  • Hypereosinophilic Syndrome
Drug: mepolizumab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2006
May 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Switzerland,   United States
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Study Director: GSK Clinical Trials GlaxoSmithKline
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP