Clinical Trials

The purpose of this study is to investigate the effectiveness and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.

The purpose of this study is to:

1. To identify predictors of inferior overall survival in HES/IHE patients including molecular parameters using next-generation sequencing performed at the point of clinical care
2. To apply the previously proposed prognostic model that included myeloid-relevant gene mutations to identify high-risk HES/IHE patients for closer monitoring

The purpose of this study is to provide a mechanism for expanded access to mepolizumab therapy for eligible patients with Hypereosinophilic Syndrome (HES).

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 ...

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to prior stable HES background therapy, and an open-label (OLE) treatment period, during which all patients will receive benralizumab. The primary database lock (DBL) will occur when at least 47 patients have had their first HES ...

The purpose of this study is to evaluate the effectiveness of depemokimab 200 mg subcutaneous (SC) given every 6 months versus placebo in participants with uncontrolled Hypereosinophilic Syndrome (HES) receiving standard of care (SoC).

This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from ...

The purpose of this study is to characterize the immunophenotype of individuals with hypereosinophilia-associated cardiovascular, gastrointestinal, hematologic, and respiratory disorders.

This study is being done to store blood cells, genetic material, blood serum and tissue biopsies so that they can be used in laboratory studies now and in the future to find causes of the rare disorder of mast cells and/or eosinophils and factors that may contribute to disease progression and treatment response.

The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.