Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00086658
First received: July 7, 2004
Last updated: November 1, 2012
Last verified: October 2012

July 7, 2004
November 1, 2012
March 2004
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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 ClinicalTrials.gov 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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hypereosinophilia
  • Hypereosinophilic Syndrome
Drug: mepolizumab
Other Name: mepolizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
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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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Switzerland
 
NCT00086658
100185
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GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

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