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NCT02377427 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT02377427: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02377427 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02377427, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits dose proportional and time-independent pharmacokinetics. The study will be conducted in 2 parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to support the use of mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma and characterize the PK/PD of mepolizumab 40 milligrams (mg) or 100 mg administered subcutaneously depending on participant body weight. Part B: It is a long-term safety / pharmacodynamic phase in which extended treatment for a further 52 weeks will be offered on an optional basis to those subjects eligible for continued treatment. Participants with bodyweight \<40 kilogram (kg) will be dosed with mepolizumab 40 mg and participants with body weight \>=40 kg will be dosed with mepolizumab 100 mg subcutaneously in upper arm or thigh at Visit 2 (Week 0). Approximately 40 male or female participants aged 6 to 11 years will be screened to achieve approximately 28 eligible participants entering the treatment phase to allow availability of 20 evaluable participants, with a minimum of six participants enrolled in the \<40 kg bodyweight group. The total duration of the study will be 22 weeks and will include a run-in period of 1-2 weeks, a treatment period of 12 weeks and a follow-up phase of 8 weeks. A participant will be considered having completed the study if the participant completes all phases of the study including the follow-up phase (Week 20 \[visit 8\]).
Primary Outcome
PK of mepolizumab was evaluated in participants using Cmax. PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. Cmax was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70 kg (mean body weight observed in adults) was not investigated in the study. PK Population
Interventions
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-08-25 |
| Est. Completion | 2018-01-31 |
| Phase | Phase 2 |
What the finished NCT02377427 record still lists
NCT02377427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Mepolizumab is the first listed.
NCT02377427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02377427 about?
NCT02377427 is a clinical study titled "Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children". Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits dose proportional and time-independent pharmacokinetics. The study will be conducted in 2 parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to support the use of mepolizum...
What is the current status of trial NCT02377427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2015-08-25. Estimated completion is 2018-01-31.
What interventions are being tested in trial NCT02377427?
The interventions under investigation include: Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT02377427?
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 NCT02377427's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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