An open-label, single arm, repeat dose, multi-centre study to evaluate the use of a safety syringe for the subcutaneous administration of mepolizumab in subjects with severe eosinophilic asthma (Study 205667)
- Conditions
- eosinophilic asthmaasthma10006436
- Registration Number
- NL-OMON45344
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
* 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.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of subjects successfully able to self-administer their observed<br /><br>third dose at Week 8.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Proportion of subjects successfully able to self-administer their unobserved<br /><br>second dose outside the<br /><br>clinic setting at Week 4. Adverse events.</p><br>