Depemokimab for Severe Asthma
(AGILE Trial)

Recruiting in Palo Alto (17 mi)

+151 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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.

Inclusion Criteria

Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

You have already finished taking part in a previous study where the treatment was kept secret from the participants and researchers.

In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Exclusion Criteria

Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study

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.

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Treatment Details

Interventions

GSK3511294 (Depemokimab) (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)Experimental Treatment1 Intervention