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NCT02105948 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 837
- Enrollment target
NCT02105948: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02105948 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 837 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02105948, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 837 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy. Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.
Primary Outcome
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization ( \>= 24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from investigational
Interventions
- DRUG Placebo
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2014-04-15 |
| Est. Completion | 2017-01-17 |
| Phase | Phase 3 |
What the finished NCT02105948 record still lists
NCT02105948 is an interventional study that assigns participants to a tested intervention. The registered 837 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02105948 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02105948 about?
NCT02105948 is a clinical study titled "Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients". This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatic...
What is the current status of trial NCT02105948?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 837 participants. The study started on 2014-04-15. Estimated completion is 2017-01-17.
What interventions are being tested in trial NCT02105948?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT02105948?
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 NCT02105948's enrollment target sits among peer trials
837 395th of 2000 higher than 1,605 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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