Last updated: 10/01/2020 13:30:16

Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

GSK study ID
100185
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: mepolizumab
Enrollment:
86
Observational study model:
Not applicable
Primary completion date:
2006-01-03
Time perspective:
Not applicable
Clinical publications:
F Roufosse, A de Lavareille, L Schandené, E Cogan, L Wagner, M Raffeld, A Klion, G Gleich, M Goldman. Mepolizumab as a Corticosteroid-sparing Agent in Lymphocytic Variant Hypereosinophilic Syndrome. J Allergy Clin Immunol. 2010;126:828-35.
Schwartz LB, Sheikh J, Singh A. Use of Mepolizumab as Corticosteroid-Sparing Therapy in Patients with Hypereosinophilic Syndrome: Report of Three Cases. Curr Med Res Opin. 2010;26(8):1933-46.
Medical condition
Hypereosinophilia
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
March 2004 to March 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
  • Documented history of Hypereosinophilic Syndrome (HES)
  • Eosinophil count greater than 1500 cells for 6 months
  • Churg-Strauss Syndrome
  • Wegener's Granulomatosis

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Status
Study Complete
Location
GSK Investigational Site
Bern, Switzerland, 3010
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20892
Status
Study Complete
Location
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Bruxelles, Belgium, 1070
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Status
Study Complete
Location
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Study Complete
Location
GSK Investigational Site
Leuven, Belgium, 3000
Status
Study Complete
Location
GSK Investigational Site
Lille, France, 59000
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Victoria, Australia, 3050
Status
Study Complete
Location
GSK Investigational Site
Montreal, Québec, Canada, H3A 1A1
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80802
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23298-0568
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Status
Study Complete
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Study Complete
Location
GSK Investigational Site
Suresnes, France, 92150
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5V 2T3
Status
Study Complete
Location
GSK Investigational Site
West Perth, Western Australia, Australia, 6005
Status
Study Complete
Location
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2006-01-03
Actual study completion date
2006-01-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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