Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01691521 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
NCT01691521 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 580 participants.
The verdict
NCT01691521, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
Study Summary
This study will evaluate two dose regimens of mepolizumab \[75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks\] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events. This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC. Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.
Interventions
- DRUG IV Placebo
- DRUG SC Placebo
- DRUG Mepolizumab IV
- DRUG Mepolizumab SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2012-10-08 |
| Est. Completion | 2014-01-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01691521
The ClinicalTrials.gov registry entry for NCT01691521 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 580 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 4 interventions - of which IV Placebo is the first listed.
NCT01691521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01691521 about?
NCT01691521 is a clinical study titled "Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma". This study will evaluate two dose regimens of mepolizumab \[75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks\] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in ...
What is the current status of trial NCT01691521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2012-10-08. Estimated completion is 2014-01-18.
What interventions are being tested in trial NCT01691521?
The interventions under investigation include: IV Placebo (DRUG), SC Placebo (DRUG), Mepolizumab IV (DRUG), Mepolizumab SC (DRUG).
Who is sponsoring clinical trial NCT01691521?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.