Depemokimab for Asthma
(SWIFT-2 Trial)

Recruiting in Palo Alto (17 mi)

+176 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing Depemokimab to help people with severe asthma that doesn't respond well to other treatments. It targets and reduces specific white blood cells to decrease inflammation and improve symptoms.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with asthma for 2 years or more, following NHLBI or GINA guidelines.

I have been diagnosed with asthma for 2 years or more, according to NHLBI or GINA guidelines.

I've needed steroids for asthma attacks at least twice in the last year despite using inhalers.

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Exclusion Criteria

I have used asthma medication recently.

Your heart's electrical activity, called the QT interval, is longer than normal.

My asthma medication dose or type hasn't changed recently.

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Treatment Details

Interventions

GSK3511294 (Depemokimab) (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GSK3511294Experimental Treatment1 Intervention

Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Group II: PlaceboPlacebo Group1 Intervention

Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.