A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults with Hypereosinophilic Syndrome (HES)
GlaxoSmithKline Research & Development Limited
This research study is being done to learn more about hypereosinophilic syndrome (HES) and if treatment with depemokimab can improve HES condition.
Depemokimab is an investigational drug, being tested as a potential new medicine for hypereosinophilic syndrome (HES).
Depemokimab is a type of medicine called a monoclonal antibody. It works by reducing the number of eosinophils in the body.
Eosinophils are white blood cells that are a normal part of the body’s immune system. However, too many eosinophils lead to inflammation, which can cause HES.
The main objective of the study is to find out how well does depemokimab works to treat people with HES compared with placebo. (A placebo, also known as a ‘dummy’ drug, is an injection that does not contain the active ingredient that may treat HES).
Participants will receive either depemokimab 200 mg or placebo every 6 months (at Week 0 and Week 26), administered SC via a prefilled safety syringe while continuing their standard of care HES therapy.
The study has 3 periods: a screening period, a treatment period, and a follow-up period.
Participants will need to visit the clinic about 18 times over a period of 14 months.
This study will include about 120 study participants globally and will last for about 1 year and 2 months.
London - Harrow Research Ethics Committee
Date of REC Opinion
17 Oct 2022
Further Information Favourable Opinion