Date: 2017-03-31
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: GSK (UK)
Product: mepolizumab
Action
mechanism:
- monoclonal antibody. Mepolizumab is a fully humanised IgG monoclonal antibody specific for interleukin 5 (IL-5). IL-5 is a cytokine which regulates the growth, activation and survival of eosinophils and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. Mepolizumab binds to human IL-5, stopping it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this manner reduces blood, tissue and sputum eosinophil levels, which in turn reduces the frequency of exacerbations.
- Mepolizumab has been granted orphan drug status for hypereosinophilic syndrome by regulatory authorities in the US and the European Union in 2004.
- The antibody is also being investigated in chronic obstructive pulmonary disease (in phase III), eosinophilic granulomatosis with polyangitis (EPGA, also referred to as Churg-Strauss syndrome, in phase III), nasal polyposis (phase II) and severe atopic dermatitis (phase I).
Disease: hypereosinophilic syndrome
Therapeutic
area: Inflammatory diseases - Rare diseases
Country:
Trial
details:
- The pivotal phase III study is a 32-week, randomised, double-blind, placebo-controlled study to investigate the efficacy and safety of subcutaneous mepolizumab 300 mg every four weeks compared with placebo in adolescent and adult patients with severe hypereosinophilic syndrome as defined by at least two HES flares within the past 12 months and a blood eosinophil count of 1000/µL or higher.
Latest
news:
- • On March 31, 2017, GSK announced the start of a phase III study with mepolizumab, an interleukin 5 (IL-5) antagonist, in patients with severe hypereosinophilic syndrome (HES).
- The study, which aims to randomise between 80-120 patients, is evaluating the effects of mepolizumab compared to placebo when added to the standard of care. The primary endpoint of the study is the proportion of patients who experience an HES flare (worsening of symptoms requiring escalation in therapy) during the 32-week study treatment period. Secondary endpoints aim to demonstrate supportive evidence for the benefit of mepolizumab compared with placebo and include time to first HES flare, the proportion of patients who experience an HES flare during week 20 through week 32, and fatigue severity.
- The results of this study will form the basis of any regulatory filing plans.
Is
general: Yes
