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NCT01366521 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils
A Phase 2 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 11
- Study locations
NCT01366521: Completed Phase 2 study of Asthma, sponsored by GlaxoSmithKline.
NCT01366521 is a Phase 2 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 70 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366521, a Phase 2 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 11
- Study locations
Study Summary
A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study
Primary Outcome
Change from Baseline in blood eosinophils was calculated as the post-Baseline value minus the Baseline value. The change from Baseline in log-transformed blood eosinophil levels at Week 12 was analyzed using both a linear and non-linear (Imax) dose response models. The dose response was found to be non-linear and hence only the results of the non-linear model are presented. Mepolizumab 75mg IV assumed to equate to 100 mg SC within model. Prior to log10-transformation, zero values were imputed wi
Conditions Studied
Interventions
- BIOLOGICAL Mepolizumab
Study Locations (11)
Other
- GSK Investigational Site - Tallinn
- GSK Investigational Site - Tartu
- GSK Investigational Site - Marseille
- GSK Investigational Site - Montpellier
- GSK Investigational Site - Pessac
North Carolina
- GSK Investigational Site - Winston-Salem
Pennsylvania
- GSK Investigational Site - Pittsburgh
Bavaria
- GSK Investigational Site - Gauting
Hesse
- GSK Investigational Site - Frankfurt am Main
Saxony-Anhalt
- GSK Investigational Site - Magdeburg
State of Berlin
- GSK Investigational Site - Berlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01366521 record still lists
NCT01366521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Mepolizumab is the first listed.
NCT01366521 lists 11 locations in 7 states (Other, North Carolina, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01366521 about?
NCT01366521 is a clinical study titled "Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils". A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynami...
What is the current status of trial NCT01366521?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-02. Estimated completion is 2012-03.
What conditions does trial NCT01366521 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01366521?
The interventions under investigation include: Mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01366521?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366521 being conducted?
This trial has 11 study locations across North Carolina, Pennsylvania, Bavaria, Hesse, Saxony-Anhalt. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01366521's enrollment target sits among peer trials
70 240th of 374 higher than 132 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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