Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)

Phase 3

Completed

• Conditions: Hypereosinophilia; Hypereosinophilic Syndrome

• Registration Number: NCT00086658
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 2004-03-23
• Study First Submitted: 2004-07-07
• Study First Submitted QC: 2004-07-08
• Study First Posted: 2004-07-09
• Primary Completion: 2006-05-01
• Study Completion: 2006-05-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇭 Bern, Switzerland