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.
Non-inferiority study of GSK3511294 compared with mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype.
You will receive either study drug or placebo, undergo research-related tests and procedures, and questionnaires. You will need to visit the study center up to 18 times over a period of 15 months. You will have different tests and procedures throughout the study. The aim is to check on your health and symptoms, check on your response to treatment and any side effects, and assess the study drug. This study will compare the study drug with either mepolizumab or benralizumab, known as the comparator medications. The effects of the drugs, both good and bad, will be compared. Study participants will be divided into 2 groups to receive: Study drug (once every 26 weeks) + placebo (once every 4 or 8 weeks) OR, Mepolizumab (once every 4 weeks) or benralizumab (once every 8 weeks) + placebo (once every 26 weeks). All participants will receive an active treatment. You will be assigned to receive either the study drug or comparator (mepolizumab or benralizumab) you were taking before the study. No participant previously taking mepolizumab will be assigned to benralizumab, and no participant previously taking benralizumab will be assigned to mepolizumab.
Have a documented diagnosis of asthma for 2 or more years.
Receiving either mepolizumab or benralizumab for 12 or more months prior to screening.
A well-documented requirement for regular treatment with medium to high dose inhaled corticosteroid in the 12 months prior to Visit 1 with or without maintenance oral corticosteroid.
Current treatment with at least one additional controller medication, besides an inhaled corticosteroids.
Current or former smokers with a smoking history of 10 or more years.
Active COVID-19 infection