Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00086658

Collaborator

(none)

Enrollment

Locations

25.3

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypereosinophilia Hypereosinophilic Syndrome	Drug: mepolizumab	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 23, 2004

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	San Diego	California	United States	92103
2	GSK Investigational Site	Denver	Colorado	United States	80206
3	GSK Investigational Site	Bethesda	Maryland	United States	20892
4	GSK Investigational Site	Boston	Massachusetts	United States	02215
5	GSK Investigational Site	Rochester	Minnesota	United States	55905
6	GSK Investigational Site	Cincinnati	Ohio	United States	45229
7	GSK Investigational Site	Nashville	Tennessee	United States	37203-1424
8	GSK Investigational Site	Houston	Texas	United States	77030
9	GSK Investigational Site	Salt Lake City	Utah	United States	84132
10	GSK Investigational Site	Richmond	Virginia	United States	23298-0568
11	GSK Investigational Site	Madison	Wisconsin	United States	53792
12	GSK Investigational Site	St Leonards	New South Wales	Australia	2065
13	GSK Investigational Site	South Brisbane	Queensland	Australia	4101
14	GSK Investigational Site	Melbourne	Victoria	Australia	3050
15	GSK Investigational Site	West Perth	Western Australia	Australia	6005
16	GSK Investigational Site	Leuven		Belgium	3000
17	GSK Investigational Site	Edmonton	Alberta	Canada	T6G 1Z2
18	GSK Investigational Site	Winnipeg	Manitoba	Canada	R3C 0N2
19	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3H 1V7
20	GSK Investigational Site	Hamilton	Ontario	Canada	L8N 3Z5
21	GSK Investigational Site	Toronto	Ontario	Canada	M5V 2T3
22	GSK Investigational Site	Montreal	Quebec	Canada	H3A 1A1
23	GSK Investigational Site	Lille		France	59000
24	GSK Investigational Site	Suresnes		France	92150
25	GSK Investigational Site	Muenchen	Bayern	Germany	80802
26	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
27	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein	Germany	24576
28	GSK Investigational Site	Bologna	Emilia-Romagna	Italy	40138
29	GSK Investigational Site	Bern		Switzerland	3010