Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Completed · Phase 3

Conditions studied: Hypereosinophilia, Hypereosinophilic Syndrome

In brief

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.

Key facts

Study ID

NCT00086658

Run by

GlaxoSmithKline

People needed

86

Starts

2004-03-23

Expected to finish

2006-05-01

Last updated by the study team

2020-05-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Churg-Strauss Syndrome
• Wegener's Granulomatosis
• Lymphoma, hematological malignancy, advanced and metastatic solid tumors
• Chemotherapy, radiotherapy or interleukin 2 treatment.

Where it is running

• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Bethesda, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Rochester, Minnesota, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Salt Lake City, Utah, United States
• GSK Investigational Site — Richmond, Virginia, United States
• GSK Investigational Site — Madison, Wisconsin, United States
• GSK Investigational Site — St Leonards, New South Wales, Australia
• GSK Investigational Site — South Brisbane, Queensland, Australia
• GSK Investigational Site — Melbourne, Victoria, Australia
• GSK Investigational Site — West Perth, Western Australia, Australia
• GSK Investigational Site — Leuven, Belgium
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Winnipeg, Manitoba, Canada
• GSK Investigational Site — Halifax, Nova Scotia, Canada
• GSK Investigational Site — Hamilton, Ontario, Canada
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Lille, France
• GSK Investigational Site — Suresnes, France
• GSK Investigational Site — Munich, Bavaria, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.