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
  Purpose

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.


Condition Intervention Phase
Hypereosinophilia
Hypereosinophilic Syndrome
Drug: mepolizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 84
Study Start Date: March 2004
Intervention Details:
    Drug: mepolizumab
    Other Name: mepolizumab
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086658

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
San Diego, California, United States, 92103
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80206
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20892
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Minnesota
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23298-0568
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Australia, New South Wales
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia, 3050
Australia, Western Australia
GSK Investigational Site
West Perth, Western Australia, Australia, 6005
Belgium
GSK Investigational Site
Leuven, Belgium, 3000
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
Toronto, Ontario, Canada, M5V 2T3
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3A 1A1
France
GSK Investigational Site
Lille, France, 59000
GSK Investigational Site
Suresnes, France, 92150
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80802
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
Switzerland
GSK Investigational Site
Bern, Switzerland, 3010
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00086658     History of Changes
Obsolete Identifiers: NCT00081445
Other Study ID Numbers: 100185
Study First Received: July 7, 2004
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Hypereosinophilic Syndrome Hypereosinophilia
mepolizumab
anti IL-5

Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014