CompletedPhase 3

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

United States, Australia, Austria1,717 participantsStarted 2021-01-26

Plain-language summary

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key inclusion criteria for study: * Adult and adolescent participants more than or equal to (\>=)12 years of age, at the time of signing the informed consent/assent. * Participants who have a documented physician diagnosis of asthma for \>=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines. * Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for \>=12 months prior to screening and have a documented benefit to therapy assessed by either: (i) \>=50% reduction in exacerbation frequency since initiating treatment, or (ii) \>=50% reduction in maintenance OCS use since initiating treatment, or (iii) No exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (\<=)1.5 at screening. * A well-documented requirement for regular treatment with medium to high dose ICS in the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS dose must be \>=440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane (HFA) product daily, or clinically comparable. Participants who are treated with medium dose ICS will also need to be treated with a LABA to qualify for inclusion. * Current treatment with at least one additional controller medication, besides ICS \[for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline\]. Key exclu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared depemokimab directly against mepolizumab and benralizumab — two treatments my doctor might already consider for my severe eosinophilic asthma — so can you walk me through what the results actually showed about how the rates of serious asthma attacks compared across those three drugs?
2Since this is a completed Phase 3 trial, does the safety and effectiveness data from it change your thinking about whether depemokimab might be an option for me, or is it still not approved or available outside of a trial setting?
3The study measured clinically significant exacerbations over a full 52 weeks — based on those results, would depemokimab offer me any meaningful advantage over mepolizumab or benralizumab in reducing my risk of serious flare-ups, given my specific eosinophil levels and asthma history?
4Depemokimab is described as a longer-acting biologic — does that mean it might require less frequent dosing than the other two drugs in this trial, and if so, would that actually make a practical difference in how I manage my treatment?
5Before considering depemokimab as a future option, are there standard treatments like mepolizumab or benralizumab that you'd recommend I try first, and how would my eosinophil count factor into that decision?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks

Timeframe: Up to Week 52

Trial details

NCT IDNCT04718389

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-14

Results submitted2026-03-13

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