Clinical Trials Logo
  1. Home
  2. Hypereosinophilic Syndrome
  3. NCT02836496

Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)

Hypereosinophilic Syndrome Clinical Trial

Official title:
Study 200622: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome

Clinical Trial Summary

Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02836496
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date March 7, 2017
Completion date August 8, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05334368 - Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial Phase 3
Recruiting NCT00044304 - Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome Phase 2
Completed NCT00171912 - Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes Phase 2
Completed NCT00097370 - Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome Phase 3
Terminated NCT00171860 - A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome Phase 2
Recruiting NCT02581514 - Eosinophilia Diagnosis N/A
Completed NCT00787384 - Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes Phase 2
Recruiting NCT03801434 - Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders Phase 2
Completed NCT00255346 - Dasatinib as Therapy for Myeloproliferative Disorders (MPDs) Phase 2
Completed NCT03306043 - A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622 Phase 3
Recruiting NCT04018118 - Natural History of Hypereosinophilia and Hypereosinophilic Syndromes
Completed NCT00086658 - Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES) Phase 3
Recruiting NCT00276926 - Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias Phase 2
Active, not recruiting NCT02101138 - Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome Phase 2
Recruiting NCT00091871 - A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression
Completed NCT01713504 - Identification of New Markers in the Hypereosinophilic Syndrome N/A
Completed NCT00017862 - Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome Phase 2
Completed NCT00038675 - Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate N/A
Terminated NCT00230334 - Phase II Gleevec Idiopathic Hypereosinophilic Syndrome Phase 2
Recruiting NCT04191304 - A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) Phase 3