A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

Phase 3

Active, not recruiting

• Conditions: Asthma
• Interventions: Biological: GSK3511294 (Depemokimab); Biological: Mepolizumab; Biological: Benralizumab; Biological: Placebo; Drug: Standard of care (SoC); Device: Pre-filled Syringes (PFS)

• Registration Number: NCT04718389
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Study Start: 2021-01-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1719

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)	Standard of care (SoC)	Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment	Pre-filled Syringes (PFS)	Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor \[anti-IL-5/5R\] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)	Benralizumab	Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment	GSK3511294 (Depemokimab)	Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor \[anti-IL-5/5R\] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment	Placebo	Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor \[anti-IL-5/5R\] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)	Placebo	Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)	Pre-filled Syringes (PFS)	Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatment	Standard of care (SoC)	Participants will receive GSK3511294 (Depemokimab) plus placebo treatment matching the active comparator (participant's anti-Interleukin-5/ 5 receptor \[anti-IL-5/5R\] treatment prior to randomization): either placebo matching mepolizumab or placebo matching benralizumab. All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)	Mepolizumab	Participants will receive active comparator (participant's anti-IL-5/5R treatment prior to randomization): either mepolizumab or benralizumab, plus placebo matching GSK3511294 (Depemokimab). All participants will continue their non-biologic Baseline SoC asthma treatment throughout the study.

Primary Outcome Measures

Name	Time	Method
Annualized rate of clinically significant exacerbations over 52 weeks	Up to Week 52	Clinically significant exacerbations of asthma are defined by worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visit. Annualized rate of exacerbations will be calculated as number of exacerbations experienced by the participant divided by the length of time the participant is measured on.

Secondary Outcome Measures

Name	Time	Method
Weighted mean change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)	Baseline (Day 1) and up to Week 52	FEV1 is a measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 will be measured using spirometry.
Weighted mean change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score	Baseline (Day 1) and up to Week 52	The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control that can be quickly and easily completed. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale. Higher score indicates more limitations.
Weighted mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score	Baseline (Day 1) and up to Week 52	The SGRQ is a well-established instrument, comprising 51 questions designed to measure Quality of Life in participants with diseases of airway obstruction. Higher score indicates worse quality of life.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Wishaw, United Kingdom