Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
Public ClinicalTrials.gov record NCT01691521. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01691521
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 580 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2012
- Primary completion
- Dec 31, 2013
- Completion
- Jan 17, 2014
- Last update posted
- Aug 5, 2018
2012 – 2014
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | Riverside | California | 92506 | — |
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | — |
| GSK Investigational Site | Denver | Colorado | 80206 | — |
| GSK Investigational Site | New Haven | Connecticut | 06520 | — |
| GSK Investigational Site | Albany | Georgia | 31707 | — |
| GSK Investigational Site | Chicago | Illinois | 60612 | — |
| GSK Investigational Site | Baltimore | Maryland | 21224 | — |
| GSK Investigational Site | Rochester | Minnesota | 55905 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | Rochester | New York | 14642 | — |
| GSK Investigational Site | Durham | North Carolina | 27705 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45229 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Cleveland | Ohio | 44195 | — |
| GSK Investigational Site | Columbus | Ohio | 43221 | — |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84132-2409 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 113 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01691521, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2018 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01691521 live on ClinicalTrials.gov.