Study Summary
This trial will see if a new drug, GSK3511294, is non-inferior to current treatments for severe asthma with an eosinophilic phenotype. All participants will continue their standard of care asthma treatment.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Baseline (Day 1) and up to Week 52
Week 52
Weighted mean change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score
Weighted mean change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score
Weighted mean change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1)
Up to Week 52
Annualized rate of clinically significant exacerbations over 52 weeks
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK351...
1 of 2
Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti...
1 of 2
Active Control
Experimental Treatment
1700 Total Participants · 2 Treatment Groups
Primary Treatment: GSK3511294 (Depemokimab) · Has Placebo Group · Phase 3
Participants receiving GSK3511294 (Depemokimab) plus placebo matching prior anti-IL-5/5R treatmentExperimental Group · 4 Interventions: Standard of care (SoC), GSK3511294 (Depemokimab), Placebo, Pre-filled Syringes (PFS) · Intervention Types: Drug, Biological, Biological, Device
Participants receiving prior anti-IL-5/5R treatment plus placebo matching GSK3511294 (Depemokimab)ActiveComparator Group · 5 Interventions: Mepolizumab, Standard of care (SoC), Benralizumab, Placebo, Pre-filled Syringes (PFS) · Intervention Types: Biological, Drug, Biological, Biological, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of care (SoC)
2020
N/A
~20
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 1) and up to week 52
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,652 Previous Clinical Trials
7,948,524 Total Patients Enrolled
287 Trials studying Asthma
407,893 Patients Enrolled for Asthma
Iqvia Pty LtdIndustry Sponsor
93 Previous Clinical Trials
232,000 Total Patients Enrolled
4 Trials studying Asthma
1,417 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,562 Previous Clinical Trials
6,131,905 Total Patients Enrolled
226 Trials studying Asthma
399,849 Patients Enrolled for Asthma
Eligibility Criteria
Age Any Age · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Nebraska | 25.0% |
| Kansas | 25.0% |
| California | 25.0% |
| Other | 25.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| GSK Investigational Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 75.0% |
| Met criteria | 25.0% |
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