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Monoclonal Antibodies
Depemokimab for Severe Asthma (AGILE 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
Must not have
Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), week 26 and week 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing Depemokimab, a medication for people with severe asthma that doesn't respond well to usual treatments. It works by reducing specific cells that cause airway inflammation, aiming to improve breathing and reduce symptoms.
Who is the study for?
This trial is for people with severe asthma who finished previous studies (206713 or 213744) without major health changes. They must be able to consent and follow study rules. In France, they need social security coverage. Those with recent other treatments, helminth infections, cancer during past studies, uncontrolled diseases besides asthma can't join.
What is being tested?
The trial tests the long-term safety and effectiveness of Depemokimab in severe eosinophilic asthma patients over 12 months. It's an extension for those who completed prior related trials and aims to understand how well the drug works over time and its effects on the immune system.
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions typical of biologic therapies such as injection site reactions, increased risk of infection, possible allergic responses or issues related to immune system alterations.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a parasitic infection in the last 6 months or have been treated for it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), week 26 and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 26 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 over 52 weeks (Scores on a scale)
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 (Scores on a scale)
Change from Baseline in pre-bronchodilator Forced expiratory volume in one second (FEV1) at Week 26 and Week 52 (Liters)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3511294 (Depemokimab)
2021
Completed Phase 3
~800
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Asthma treatments often target the inflammatory pathways involved in the disease. Monoclonal antibodies like Depemokimab (an anti-IL-5 antibody) work by inhibiting IL-5, a cytokine crucial for the growth, activation, and survival of eosinophils, which are inflammatory cells that contribute to asthma symptoms.
By reducing eosinophil levels, these treatments help decrease airway inflammation and improve asthma control. This is particularly important for patients with severe eosinophilic asthma, as it can lead to fewer exacerbations and better overall lung function.
Other common treatments include inhaled corticosteroids, which reduce inflammation broadly, and bronchodilators, which relax airway muscles to improve breathing.
Find a Location
Who is running the clinical trial?
Iqvia Pty LtdIndustry Sponsor
116 Previous Clinical Trials
173,929 Total Patients Enrolled
4 Trials studying Asthma
2,522 Patients Enrolled for Asthma
GlaxoSmithKlineLead Sponsor
4,805 Previous Clinical Trials
8,379,208 Total Patients Enrolled
301 Trials studying Asthma
499,981 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,248 Total Patients Enrolled
230 Trials studying Asthma
401,710 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken part in a research study or used an experimental medication within the last 30 days or within 5 times the drug's half-life, whichever is longer, before starting this study.I have a new or existing cancer, but skin cancer treated by surgery doesn't count.I do not have any uncontrolled health issues unrelated to asthma that would make me unsuitable for the study.You have already finished taking part in a previous study where the treatment was kept secret from the participants and researchers.I have not had a parasitic infection in the last 6 months or have been treated for it.Participants who meet certain requirements based on their assessment results at Week 48 from Study 206713 or Study 213744, or from a later assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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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