A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
NCT04718389 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1717
Last updated 2026-05-18
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
- BIOLOGICAL
-
GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.
- BIOLOGICAL
-
Mepolizumab
Mepolizumab 100 mg SC will be administered in a single-use PFS.
- BIOLOGICAL
-
Benralizumab
Benralizumab 30 mg will be administered in a single-use PFS.
- BIOLOGICAL
-
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.
Sponsors & Collaborators
-
IQVIA Pty Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-26
- Primary Completion
- 2025-09-14
- Completion
- 2025-09-14
- FDA Drug
- Yes
- FDA Device
- Yes
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
Study Locations
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