A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study 201312: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects With a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial|
- Annualized rate of exacerbations [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]Exacerbations will be defined as worsening of asthma which requires use of systemic corticosteroids (CS) and/or hospitalisation and/or emergency department (ED) visits.
- Frequency of all adverse events (AEs) [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]Descriptive analysis of the safety profile of mepolizumab.
- Frequency of positive anti-mepolizumab binding antibodies/neutralizing antibodies [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]Blood samples will be collected for the determination of anti-mepolizumab antibodies, just prior to administration of mepolizumab. Samples testing positive for anti-mepolizumab antibodies will be further tested for neutralising antibody.
- Asthma Control Questionnaire-5 score [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]The Asthma Control Questionnaire-5 (ACQ-5) is a five-item questionnaire used to measures a subject's asthma control.
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]FEV1 is a measure of lung function.
- Number of withdrawals due to lack of efficacy [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]The number of subject withdrawals due to lack of efficacy will be summarized.
- Number of withdrawals due to AEs [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]The number of subject withdrawals due to adverse events will be summarized.
- Number of hospitalizations due to AEs including asthma exacerbations [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]The number of subject hospitalizations due to adverse events or exacerbations will be summarized.
- Frequency of both systemic (i.e., allergic and non-allergic) and local site reactions [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]A summary of AEs of special interest.
- 12 lead ECG parameters [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]A summary of the mean changes in specific safety ECG parameters from baseline.
- Safety as assessed by vital signs [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]Vital signs including sitting pulse rate and blood pressure measurements.
- Safety as assessed by clinical laboratory parameters [ Time Frame: Up to Weeks 128 ] [ Designated as safety issue: No ]Clinical laboratory tests as measured by parameters for hematology and clinical chemistry.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Mepolizumab 100 mg
All subjects will receive mepolizumab 100mg administered SC into the upper arm or thigh approximately every 4 weeks.
Mepolizumab is a fully humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks. Mepolizumab will be supplied as a lyophilised cake in sterile vials for individual use.Drug: SOC
Standard of Care (SOC) will differ by participant, however it will generally include oral corticosteroids and an inhaled controller medicine (an inhaled corticosteroid plus a long acting beta agonist) and/or short acting beta agonists
Please refer to this study by its ClinicalTrials.gov identifier: NCT02135692
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|