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NCT Number: NCT00086658

Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (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.

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Key information

Conditions

Hypereosinophilia Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypereosinophilic Syndrome Leukocyte Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, St Leonards, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepolizumab

Drug

Primary outcomes

  1. Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 9, 2004
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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