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NCT04133909 · ClinicalTrials.gov registry record · Phase 3
Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 806
- Enrollment target
NCT04133909 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 806 participants.
The verdict
NCT04133909, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 806 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.
Interventions
- DRUG Placebo
- BIOLOGICAL Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 806 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2024-08-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04133909
The ClinicalTrials.gov registry entry for NCT04133909 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 806 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04133909 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04133909 about?
NCT04133909 is a clinical study titled "Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level". This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD...
What is the current status of trial NCT04133909?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 806 participants. The study started on 2019-10-30. Estimated completion is 2024-08-08.
What interventions are being tested in trial NCT04133909?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04133909?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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