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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00086658
Other study ID # 100185
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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Completed NCT00017862 - Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome Phase 2
Terminated NCT00230334 - Phase II Gleevec Idiopathic Hypereosinophilic Syndrome Phase 2
Recruiting NCT04191304 - A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) Phase 3