Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children
Status:
Completed
Trial end date:
2018-01-31
Target enrollment:
Participant gender:
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]).