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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing Effects of Mepolizumab 750 mg Intravenous 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.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing Effects of Mepolizumab 750 mg Intravenous 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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000929-30-IT
Enrollment
84
Registered
2005-05-12
Start date
2004-07-08
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HES MedDRA version: 6.1 Level: PT Classification code 10048643

Interventions

Product Name: Mepolizumab Product Code: SB240563 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: SB-240563 Concentration unit: mg milligram(s) Concentration type: equa

Sponsors

GLAXO SMITHKLINE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026