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
Study complete
Study complete
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
    Primary completion date:
    2006-01-03
    Observational study model:
    Not applicable
    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
    Study complete
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website