NCT00086658

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

Geographic Reach
8 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

2.1 years

First QC Date

July 7, 2004

Last Update Submit

May 1, 2020

Conditions

HypereosinophiliaHypereosinophilic Syndrome

Keywords

Hypereosinophilic Syndrome Hypereosinophiliamepolizumabanti IL-5

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks

Secondary Outcomes (1)

  • 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.

Interventions

mepolizumabDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Churg-Strauss Syndrome
  • Wegener's Granulomatosis
  • Lymphoma, hematological malignancy, advanced and metastatic solid tumors
  • Chemotherapy, radiotherapy or interleukin 2 treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

Denver, Colorado, 80206, United States

Location

GSK Investigational Site

Bethesda, Maryland, 20892, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45229, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203-1424, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84132, United States

Location

GSK Investigational Site

Richmond, Virginia, 23298-0568, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53792, United States

Location

GSK Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

GSK Investigational Site

South Brisbane, Queensland, 4101, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3050, Australia

Location

GSK Investigational Site

West Perth, Western Australia, 6005, Australia

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3C 0N2, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5V 2T3, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3A 1A1, Canada

Location

GSK Investigational Site

Lille, 59000, France

Location

GSK Investigational Site

Suresnes, 92150, France

Location

GSK Investigational Site

Munich, Bavaria, 80802, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

Location

GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

Location

GSK Investigational Site

Bern, 3010, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 20810155DERIVED

  • 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.

    PMID: 18344568DERIVED

MeSH Terms

Conditions

EosinophiliaHypereosinophilic Syndrome

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Leukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2004

First Posted

July 9, 2004

Study Start

March 23, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations

CA(6)CH(1)IT(1)AU(4)BE(1)FR(2)DE(3)US(11)