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Compensation: Varies

Number of Visits: 2

Duration: 52 weeks

397 Participants Needed

Depemokimab for Asthma
(SWIFT-2 Trial)

Recruiting at 176 trial locations

Overseen ByUS GSK Clinical Trials Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: ICS, LABA

Must not be taking: Anti-IL-5, mAb

Disqualifiers: Lung conditions, Cancer, Vasculitis, others

Stay on Your Current MedsYou can continue your current medications while participating

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants must be on regular treatment with medium to high-dose inhaled corticosteroids and at least one additional controller medication for asthma. It's best to discuss your specific medications with the trial team.

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.

See 10 more

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.

See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK3511294 or placebo subcutaneous injection every 26 weeks, while maintaining their existing baseline maintenance asthma standard of care treatment

52 weeks

2 visits (in-person) at week 0 and week 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

GSK3511294 (Depemokimab)

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

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Depemokimab for Asthma (SWIFT-2 Trial)