NCT02836496 - Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES) | Biotech Hunter

Enrollment

108

Participants

Timeline

Start Date

March 7, 2017

Primary Completion Date

August 8, 2019

Study Completion Date

August 8, 2019

Conditions

Hypereosinophilic Syndrome

Interventions

DRUG

Mepolizumab 300 mg

Mepolizumab is available as lyophilized powder for injection reconstituted with Sterile Water for Injection, just prior to use.

DRUG

Placebo matching mepolizumab

Placebo is available as 0.9% sodium chloride solution

DRUG

Active OCS capsules (5 mg prednisolone or prednisone)

All subjects will be provided with 2 bottles of blinded OCS capsules, one containing 5mg OCS capsules (active OCS treatment) and a second one containing matching placebo capsules (placebo OCS treatment). These will be dispensed to each subject at each scheduled clinic visit and as needed. Subjects with an increase in blood eosinophils above the pre-specified threshold will be instructed to start blinded OCS treatment from one of the bottles provided (active treatment) unless the subject's HES therapy has already been increased due to a symptom flare within the past 2 weeks.

DRUG

Placebo matching OCS capsules

All subjects will be provided with 2 bottles of blinded OCS capsules, one containing 5mg OCS capsules (active OCS treatment) and a second one containing matching placebo capsules (placebo OCS treatment). These will be dispensed to each subject at each scheduled clinic visit and as needed.A subject who does not reach the pre-specified blood eosinophil threshold with a similar blood draw date will be selected to initiate a placebo OCS treatment in a blinded manner, unless the subject's HES therapy has already been increased due to a symptom flare within the past 2 weeks.

Trial Locations (43)

1070

GSK Investigational Site, Brussels

3000

GSK Investigational Site, Leuven

7600

GSK Investigational Site, Mar del Plata

29425

GSK Investigational Site, Charleston

30625

GSK Investigational Site, Hanover

31059

GSK Investigational Site, Toulouse

36043

GSK Investigational Site, Fulda

44093

GSK Investigational Site, Nantes

44100

GSK Investigational Site, Guadalajara

44124

GSK Investigational Site, Mayfield Heights

45229

GSK Investigational Site, Cincinnati

46026

GSK Investigational Site, Valencia

50134

GSK Investigational Site, Florence

55905

GSK Investigational Site, Rochester

59037

GSK Investigational Site, Lille

64710

GSK Investigational Site, Monterrey

68167

GSK Investigational Site, Mannheim

73230

GSK Investigational Site, Kirchheim -Teck

80131

GSK Investigational Site, Napoli

80802

GSK Investigational Site, Munich

84132

GSK Investigational Site, Salt Lake City

86035

GSK Investigational Site, Villahermosa

92150

GSK Investigational Site, Suresnes

125167

GSK Investigational Site, Moscow

193024

GSK Investigational Site, Saint Petersburg

197341

GSK Investigational Site, Saint Petersburg

400124

GSK Investigational Site, Cluj-Napoca

540327

GSK Investigational Site, Târgu Mureş

90610000

GSK Investigational Site, Porto Alegre

92037-0641

GSK Investigational Site, San Diego

06520

GSK Investigational Site, New Haven

C1028AAP

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

Unknown

GSK Investigational Site, La Plata

C1425BEN

GSK Investigational Site, Buenos Aires

89030-101

GSK Investigational Site, Blumenau

09080-110

GSK Investigational Site, Santo André - SP

18040-425

GSK Investigational Site, Sorocaba

31-066

GSK Investigational Site, Krakow

90-153

GSK Investigational Site, Lodz

010306

GSK Investigational Site, Bucharest

08035

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

LE3 9QP

GSK Investigational Site, Leicester