NIMBLE

Contents

A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab (NIMBLE)

What is the study trying to find out?

GSK3511294 (also called the “study drug”) is being tested as a potential new medicine for severe asthma and is not yet approved to treat patients with asthma.

The study drug is a type of medicine called a monoclonal antibody that is made in the laboratory. It works by blocking a specific protein in the body called interleukin-5 which is involved in the severity of asthma and inflammation of the lungs.

This clinical research study is being done to learn whether the study drug works at least as well as the medication you have been using to treat your condition (mepolizumab or benralizumab). The study will also look at if the study drug is safe and has any side effects.

The study drug works in the same way as 3 already approved asthma medications: mepolizumab, reslizumab, and benralizumab. These medications are taken every 4 to 8 weeks. However, it is hoped that the effect of the study drug will last over a longer period of time so it can be given twice a year (once every 26 weeks).