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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.Secondary study objectives
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at Week 52 (scores on a scale)
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 52 (scores on a scale)
Change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at Week 52 (liters)
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: Participants receiving GSK3511294 (Depemokimab)Experimental Treatment1 Intervention
Participants will be administered GSK3511294 (Depemokimab) along with SoC.
Group II: Participants receiving placeboPlacebo Group1 Intervention
Participants will be administered matching placebo along with SoC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3511294 (Depemokimab)
2021
Completed Phase 3
~800
Find a Location
Who is running the clinical trial?
Iqvia Pty LtdIndustry Sponsor
116 Previous Clinical Trials
174,175 Total Patients Enrolled
4 Trials studying Asthma
2,768 Patients Enrolled for Asthma
GlaxoSmithKlineLead Sponsor
4,806 Previous Clinical Trials
8,380,454 Total Patients Enrolled
301 Trials studying Asthma
500,227 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,494 Total Patients Enrolled
230 Trials studying Asthma
401,956 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: Participants receiving GSK3511294 (Depemokimab)
- Group 2: Participants receiving 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.
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