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Depemokimab for Asthma (SWIFT-2 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
Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines
Documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and at week 52
Awards & highlights
SWIFT-2 Trial Summary
This trial will test a new drug to see if it can help people with severe asthma that isn't well controlled and has a lot of eosinophils.
Who is the study for?
This trial is for adults and adolescents (12 years or older) with severe uncontrolled asthma characterized by an eosinophilic phenotype. Participants must have been diagnosed with asthma for at least 2 years, following specific guidelines, and should be on a stable dose of high-dose inhaled corticosteroids. They need to have had two or more exacerbations requiring systemic steroids in the past year.Check my eligibility
What is being tested?
The study tests Depemokimab as additional therapy for those with severe eosinophilic asthma. It compares the effects of Depemokimab against a placebo to see if it improves symptoms and control of asthma.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, fatigue, and possible allergic reactions among others.
SWIFT-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with asthma for 2 years or more, following NHLBI or GINA guidelines.
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I have been diagnosed with asthma for 2 years or more, according to NHLBI or GINA guidelines.
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I've needed steroids for asthma attacks at least twice in the last year despite using inhalers.
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I use a medium to high dose inhaler for my asthma daily.
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I am 12-17 years old with specific lung function test results below normal.
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I've had 2 or more severe asthma attacks in the last year despite using my regular medication.
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I have breathing issues with less than 80% normal lung function.
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I am 12 years old or older.
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My lung function tests show I have airflow obstruction.
SWIFT-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and at week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and at week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized rate of clinically significant exacerbations over 52 weeks
Secondary outcome measures
Annualized rate of exacerbations requiring hospitalization and/or Emergency Department (ED) visit over 52 weeks
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at Week 52
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 52
+1 moreSWIFT-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving GSK3511294 (Depemokimab)Experimental Treatment1 Intervention
Participants will receive GSK3511294 (Depemokimab) during the study. All participants will continue their Baseline SoC asthma treatment throughout the study.
Group II: Participants receiving PlaceboPlacebo Group1 Intervention
Participants will receive placebo during the study. All participants will continue their Baseline SoC asthma treatment throughout the study.
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,075 Total Patients Enrolled
294 Trials studying Asthma
415,030 Patients Enrolled for Asthma
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,611 Total Patients Enrolled
4 Trials studying Asthma
2,762 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,533 Total Patients Enrolled
229 Trials studying Asthma
401,847 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with asthma for 2 years or more, following NHLBI or GINA guidelines.I have used asthma medication recently.I have been diagnosed with asthma for 2 years or more, according to NHLBI or GINA guidelines.Your heart's electrical activity, called the QT interval, is longer than normal.I've needed steroids for asthma attacks at least twice in the last year despite using inhalers.I use a medium to high dose inhaler for my asthma daily.My asthma medication dose or type hasn't changed recently.I have a condition that increases my eosinophil count.I am 12-17 years old with specific lung function test results below normal.I have a significant lung condition that is not asthma.I do not have any uncontrolled serious health issues.I am 12 years old or older.I've had 2 or more severe asthma attacks in the last year despite using my regular medication.I have breathing issues with less than 80% normal lung function.I am 12 years old or older.I do not have cirrhosis or current unstable liver/biliary disease.I have been diagnosed with vasculitis.I likely have asthma with an eosinophilic phenotype.I've been on a second asthma medication besides inhaled steroids for over 3 months.My cancer has been in remission for less than a year, except for skin cancer.You have a heart condition, smoke, or can't tolerate certain medications.I have not had a severe asthma attack in the last week.My lung function tests show I have airflow obstruction.I have asthma with a high number of eosinophils.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there many sites running this clinical trial in Canada?
"50 different medical centres are enrolling patients for this clinical trial. If you decide to participate in the study, please choose a location nearest to you from the list of 50 sites. This will minimize travel requirements."
Answered by AI
What is GSK3511294's (Depemokimab) standing with the FDA?
"Given that this is a Phase 3 trial with both efficacy and safety data, GSK3511294 (Depemokimab) was given a score of 3 for safety."
Answered by AI
Can people with the qualifying medical condition join this research study at this time?
"This study is looking for patients, as indicated on clinicaltrials.gov. The listing was first posted on 3/11/2021 and last updated on 10/21/2022."
Answered by AI
Can you give me an estimate of how many people will be participating in this trial?
"Yes, according to the clinicaltrials.gov website, this trial is open for recruitment. The study was originally posted on March 11th, 2021 and updated on October 21st, 2022. They are looking for 375 participants across 50 different locations."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Other
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
How responsive is this trial?
Typically responds via
Email
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