At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GSK3511294 (Depemokimab), Mepolizumab, and 4 other interventions for Asthma. Completed, enrolled 1,717 participants across 397 sites in 21 countries.
Detailed Summary
This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.
Study Details
Timeline
Interventions
GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.
Mepolizumab 100 mg SC will be administered in a single-use PFS.
Benralizumab 30 mg will be administered in a single-use PFS.
Placebo will be a sterile liquid formulation.
Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
PFS will include glass barrel with pre-staked needle and plunger.