Clinical trial NCT00086658: Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypereosinophilia
Hypereosinophilic Syndrome
Keywords: Hypereosinophilic Syndrome Hypereosinophilia
mepolizumab
anti IL-5
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-07-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: West Perth
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Lille
country: France
facility: GSK Investigational Site
city: Suresnes
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bad Bramstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Bern
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Roufosse F, de Lavareille A, Schandene L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049.
citation: Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16.