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NCT04718389 · ClinicalTrials.gov registry record · Phase 3
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,717
- Enrollment target
NCT04718389: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04718389 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,717 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04718389, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,717 participants
- Enrollment target
Study 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.
Primary Outcome
Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \[such as intramuscular (IM), intravenous (IV) or oral\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Benralizumab
- BIOLOGICAL Mepolizumab
- DRUG Standard of care (SoC)
- BIOLOGICAL GSK3511294 (Depemokimab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,717 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2025-09-14 |
| Phase | Phase 3 |
What the finished NCT04718389 record still lists
NCT04718389 is an interventional study that assigns participants to a tested intervention. Its 1,717 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04718389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04718389 about?
NCT04718389 is a clinical study titled "A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype". 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 eosinophil...
What is the current status of trial NCT04718389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,717 participants. The study started on 2021-01-26. Estimated completion is 2025-09-14.
What interventions are being tested in trial NCT04718389?
The interventions under investigation include: Placebo (BIOLOGICAL), Benralizumab (BIOLOGICAL), Mepolizumab (BIOLOGICAL), Standard of care (SoC) (DRUG), GSK3511294 (Depemokimab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04718389?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04718389's enrollment target sits among peer trials
1,717 130th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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