GSK3511294 (Depemokimab) for Asthma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
AsthmaGSK3511294 (Depemokimab) - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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

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Who else is applying?

What state do they live in?
Nebraska25.0%
Kansas25.0%
California25.0%
Other25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
GSK Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria75.0%
Met criteria25.0%