Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Hypereosinophilic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086658
• Other study ID #: 100185
• Status: Completed
• Phase: Phase 3
• Start date: March 23, 2004
• Est. completion date: May 1, 2006

Study information

• Verified date: May 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT00081445

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 1, 2006
• Est. primary completion date: May 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypereosinophilia
• Hypereosinophilic Syndrome
• Syndrome

Intervention

Drug:
• mepolizumab

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	South Brisbane	Queensland
Australia	GSK Investigational Site	St Leonards	New South Wales
Australia	GSK Investigational Site	West Perth	Western Australia
Belgium	GSK Investigational Site	Leuven
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Suresnes
Germany	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Muenchen	Bayern
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Switzerland	GSK Investigational Site	Bern
United States	GSK Investigational Site	Bethesda	Maryland
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks
Secondary	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.