MEPO PK-PD Paediatric Study in Severe Eosinophilic Asthma
Research type
Research Study
Full title
An open-label study to characterize the pharmacokinetics and pharmacodynamics of mepolizumab administered subcutaneously in children from 6 to 11 years of age with severe eosinophilic asthma
IRAS ID
174025
Contact name
Louise Fleming
Contact email
Eudract number
2014-002666-76
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IN, Regulatory Agency Identifying Number
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
This is a GSK sponsored trial in children between 6-11 years old with severe eosinophilic asthma.
The main objective of the study is to characterise how the body reacts and how the drug (mepolizumab) behaves in the body of children to understand if the safety and efficacy data already available from adult studies can be used to support the use of the study drug in the paediatric population. Safety, tolerability and whether the study treatment is able to provoke a response from the natural’s body defence system will be also studied along with clinical outcomes measurements.
Approximately 28 subjects will be randomised to receive mepolizumab as an injection under the skin in different concentrations depending on their bodyweight. A minimum of 6 subjects will receive 40 mg (body weight lower than 40 kg) and the rest will receive 100 mg (body weight 40 kg or above). Subjects will receive this treatment every four weeks; there will be a total of three injections.
Treatment may be stopped if unacceptable side effects occur, or if the subjects are unable to continue the treatment, or are requesting to discontinue the study. Subjects will be recruited in hospital clinics and will need to attend a set of visits in which subjects will receive treatment, be examined, be asked about general well-being and blood tests will be taken. Subjects participating in the study may be seen more frequently than those who do not. Study duration will be approximately 22 weeks. Subjects will be followed up for 12 wks after last study drug dose. It is hoped that this study will contribute to further information to provide access to as well as safe and efficacious use of new medicines to the paediatric population.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0718
Date of REC Opinion
17 Jun 2015
REC opinion
Further Information Favourable Opinion