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Monoclonal Antibodies
Depemokimab for Severe Asthma (AGILE Trial)
Phase 3
Recruiting
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), week 26 and week 52
Awards & highlights
AGILE Trial Summary
This trial will study the long-term effects of an experimental drug for severe asthma.
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.Check my eligibility
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.See study design
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.
AGILE Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks
Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294 over 52 weeks
Secondary outcome measures
Annualized rate of clinically significant exacerbations over 52 weeks
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)
+1 moreAGILE Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)Experimental Treatment1 Intervention
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Who is running the clinical trial?
Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
169,431 Total Patients Enrolled
4 Trials studying Asthma
2,522 Patients Enrolled for Asthma
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,179 Total Patients Enrolled
295 Trials studying Asthma
415,926 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,293 Total Patients Enrolled
229 Trials studying Asthma
401,607 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any caps on the number of people who can enroll in this trial?
"Yes, this is an ongoing trial that was first announced on March 1st, 2022. The most recent update to the study's information was made on September 30th, 2022. So far, 637 patients have been enrolled from 1 sites."
Answered by AI
Are patients with asthma who are being given GSK3511294 (Depemokimab) part of an FDA-sanctioned clinical trial?
"Given that this is a Phase 3 trial, which suggests both efficacy and safety data from multiple rounds of testing, our team at Power has given GSK3511294 (Depemokimab) a score of 3 for safety in participants diagnosed with asthma."
Answered by AI
Who else is applying?
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
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