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NCT02105961 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 674
- Enrollment target
NCT02105961 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 674 participants.
The verdict
NCT02105961, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 674 participants
- Enrollment target
Study Summary
This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.
Interventions
- DRUG Placebo
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2014-04-24 |
| Est. Completion | 2017-01-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02105961
The ClinicalTrials.gov registry entry for NCT02105961 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 674 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.
NCT02105961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02105961 about?
NCT02105961 is a clinical study titled "Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)". This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in ...
What is the current status of trial NCT02105961?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 674 participants. The study started on 2014-04-24. Estimated completion is 2017-01-16.
What interventions are being tested in trial NCT02105961?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT02105961?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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