Your session is about to expire
← Back to Search
Monoclonal Antibodies
Depemokimab for Asthma (SWIFT-1 Trial)
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and week 52
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new medication called Depemokimab for people with severe asthma that isn't controlled by other treatments. These patients have high levels of a specific white blood cell called eosinophils. Depemokimab works by reducing these cells to help lower inflammation and improve asthma symptoms.
Eligible Conditions
- Asthma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks
Secondary study objectives
Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52
Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52
+3 moreSide effects data
From 2023 Phase 3 trial • 395 Patients • NCT0471983220%
COVID-19
12%
Nasopharyngitis
10%
Upper respiratory tract infection
8%
Influenza
6%
Rhinitis
5%
Bronchitis
5%
Headache
4%
Laryngitis
4%
Lower respiratory tract infection
4%
Sinusitis
4%
Cough
4%
Rhinitis allergic
4%
Hypertension
3%
Pharyngitis
3%
Respiratory tract infection
2%
Back pain
1%
Asthma
1%
Gastrooesophageal reflux disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GSK3511294
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK3511294Experimental Treatment1 Intervention
Participants received a 100 milligram (mg) dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3511294 (Depemokimab)
2021
Completed Phase 3
~400
Find a Location
Who is running the clinical trial?
Iqvia Pty LtdIndustry Sponsor
118 Previous Clinical Trials
176,435 Total Patients Enrolled
4 Trials studying Asthma
2,735 Patients Enrolled for Asthma
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,175 Total Patients Enrolled
302 Trials studying Asthma
500,110 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,145,069 Total Patients Enrolled
230 Trials studying Asthma
401,923 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pre-bronchodilator FEV1 less than 80% predicted.You have, or with high likelihood of having, asthma with an eosinophilic phenotype.You are allergic or intolerant to the ingredients in GSK3511294 or any other similar medications.You have taken certain medications called mepolizumab, reslizumab, or benralizumab in the last year, or you have tried other medications that target a specific protein called IL-5 or its receptor and they didn't work for you.You have certain conditions that can cause high levels of a specific type of white blood cell called eosinophils.You have a documented physician diagnosis of asthma for at least 2 years that meets the National Heart, Lung, and Blood Institute (NHLBI) guidelines or Global Initiative for Asthma (GINA) guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: GSK3511294
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.