The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSK-sponsored mepolizumab study. During the execution of the protocol SAEs…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
NA
Secondary outcome
NA
Background summary
Mepolizumab is a fully humanized IgG antibody (IgG1, kappa) which binds to and
inhibits the ability of
IL-5 to bind to the IL-5 receptor. IL-5 receptors are primarily expressed on
eosinophils. IL-5, through
binding to the IL-5 receptor is a major regulator of eosinophils resulting in
accumulation in tissues and
modulation of eosinophil behavior at every stage from maturation to survival.
Mepolizumab reduces
eosinophils in the periphery and in tissues.
Mepolizumab is being developed for the treatment of a.o. severe astma.
This new protocol (201956) has been designed in order to provide further access
to treatment with mepolizumab for subjects with severe asthma who participated
in a GSK-sponsored mepolizumab clinical study.
In the Netherlands this applies to subjects from the 200862 study. In this
study the efficacy of mepolizumab administered in addition to standard of care
in subjects aged 16 years and above diagnosed with an acute exacerbation of
asthma has been evaluated.
Study objective
The objective of this protocol is to provide a mechanism to supply mepolizumab
on an individual subject basis to eligible asthma subjects who previously
participated in a GSK-sponsored mepolizumab study. During the execution of the
protocol SAEs will be collected.
Study design
Long-term Access Programme (LAP) to support provision of open-label mepolizumab
on an individual basis to eligible subjects with severe asthma who participated
in a clinical study with mepolizumab. Mepolizumab can be initiated within 6
months following the individual subject*s last scheduled visit in the preceding
clinical study. Initiation after more than 6 months will be considered on an
individual basis by the sponsor.
Treatment: subcutaneously administered mepolizumab at a dose of 100 mg every 4
weeks.
Mepolizumab treatment under this LAP can continue until mepolizumab is
commercially licensed for the treatment of asthma in NL or until the sponsor
discontinues development in asthma or until the subject meets any of the
withdrawal/stopping criteria.
Intervention
Treatment with mepolizumab.
Study burden and risks
Risk: adverse events of mepolizumab.
Burden: subcutaneous injections with mepolizumab every 4 weeks.
Huis ter Heideweg 61
Zeist 3705 LZ
NL
Huis ter Heideweg 61
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
• Participated in GSK-sponsored asthma clinical study with mepolizumab as specified in the protocol, appendix 2.
• either:
1. completed the treatment period in the mepolizumab asthma clinical study to which they were originally enrolled
or
2. if the subject was withdrawn from study treatment prematurely during the mepolizumab asthma clinical study to which they were originally enrolled but the subject has completed the study assessments at the study visit that would have been the end of the respective treatment period.
• The treating physician considers the benefits of treatment with mepolizumab outweigh the risks for the individual subject.
• Adequate contraception for females of childbearing potential.
Exclusion criteria
• Subject had an adverse event (serious or non-serious) considered related to study treatment whilst participating in a clinical study with mepolizumab which resulted in permanent withdrawal of study treatment.
• Treatment with another biological therapy.
• Treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives.
• Current participation in any other interventional clinical study.
• Pregnancy or breastfeeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-001152-29-NL |
| CCMO | NL53979.100.15 |
| Other | www.gskclinicalstudyregister.com; registratienummer 201956 |