Primary:To assess the use of mepolizumab in safety syringe for the subcutaneous self-administration of mepolizumab by subjects with severe eosinophilic asthma.Secondary:To assess the use of mepolizumab in safety syringe outside the clinic setting.…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of subjects successfully able to self-administer their observed
third dose at Week 8.
Secondary outcome
Proportion of subjects successfully able to self-administer their unobserved
second dose outside the
clinic setting at Week 4. Adverse events.
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 eosinophilic
asthma and has been registered as add-on treatment for severe refractory
eosinophilic asthma in adults.
This new study has been designed to assess the correct real-world use of a
safety syringe for the repeat self-administration of mepolizumab subcutaneously
by determining the proportion of subjects with severe eosinophilic asthma who
are successfully able to self-administer a dose of mepolizumab.
The formulation of mepolizumab that will be studied in this clinical trial has
not yet been administered in a clinical trial. In parallel a PK study in
healthy volunteers will be conducted to confirm the comparable PK prophyle with
the marketed formulation.
Study objective
Primary:
To assess the use of mepolizumab in safety syringe for the subcutaneous
self-administration of mepolizumab by subjects with severe eosinophilic asthma.
Secondary:
To assess the use of mepolizumab in safety syringe outside the clinic setting.
Safety and tolerability of mepolizumab in the safety syringe.
Study design
Open-label, non comparative, repeat-dose, multi-centre study. 3 administrations
of mepolizumab 100 mg S.C. every 4 weeks. Treatment period 12 weeks.
1st and 3rd administration in hospital; 2nd administration at home. All
administrations by subject or caregiver. Instructions by study staff and
reading of user instructions prior to 1st injection. Completion of checklist by
subject or caregiver after 2nd injection. Presence of observer (who completes
checklist) during 3rd injection.
Follow-up period 4 weeks.
Estimation 75 subjects screened, 55 enrolled.
Intervention
Treatment with mepolizumab.
Study burden and risks
Risk: Adverse events of mepolizumab.
Burden:
5-6 visits in up to 18 weeks.
3 SC injections with mepolizumab (approx. 1 ml).
Physical examination: 2 times.
Blood draws: 5 times (5-15 ml blood).
Pregnancy test: 5 times.
ECG: 2 times.
Completion of checklist after 2nd injection (at home).
Questionnaire about pain at injection site immediately after and 1 and 24 hours
after each injection.
Optional genetic blood sample.
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
* 12 years and above (NL: 18 years and above).
* Diagnosis of asthma for *2 years in line with the NIH 2007 guidelines or GINA 2015 guidelines.
* Severe eosinophilic asthma who have been treated with mepolizumab for at least 12 weeks or who have been using high dose inhaled corticosteroids plus an additional controller with a history of 1 or more exacerbations in the last 12 months. See protocol page 25-26 for more details.
* Adequate contraception for females of childbearing potential. See protocol page 26 for details.
Exclusion criteria
* Presence of a known pre-existing, clinically important lung condition other than asthma. See protocol page 27 for details.
* Other conditions that could lead to elevated eosinophils. See protocol page 27 for details.
* Known, pre-existing, unstable liver disease. See protocol page 27 for details.
* A current malignancy or previous history of cancer in remission for less than 12 months. See protocol page 27 for details.
* QTcF prolongation on ECG. See protocol page 27 for details.
* Any monoclonal antibody (including Xolair within 130 days) to treat inflammatory disease within 5 half-lives of Visit 1.
* 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 | EUCTR2016-001831-10-NL |
| CCMO | NL59990.100.16 |
| Other | www.gskclinicalstudyregister.com, nummer 205667 |