Trials / Completed
CompletedNCT04718389
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,719 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK3511294 (Depemokimab) | GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS). |
| BIOLOGICAL | Mepolizumab | Mepolizumab will be provided in a single-use PFS. |
| BIOLOGICAL | Benralizumab | Benralizumab will be provided in a single-use PFS. |
| BIOLOGICAL | Placebo | Placebo will be a sterile liquid formulation. |
| DRUG | Standard of care (SoC) | 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). |
| DEVICE | Pre-filled Syringes (PFS) | PFS will include glass barrel with pre-staked needle and plunger. |
Timeline
- Start date
- 2021-01-26
- Primary completion
- 2025-09-14
- Completion
- 2025-09-14
- First posted
- 2021-01-22
- Last updated
- 2025-10-15
Locations
397 sites across 21 countries: United States, Australia, Austria, Canada, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, Portugal, Puerto Rico, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04718389. Inclusion in this directory is not an endorsement.