Subjects with severe, refractory asthma and a history of eosinophilic inflammation.
Conditions
Interventions
Product Name: Mepolizumab
Product Code: SB240563
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Mepolizumab
Sponsors
GlaxoSmithKline Research and Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent. 2. MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial. 3. MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio in the opinion of the investigator. 4. Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks. Subjects will be expected to continue controller therapy for the duration of the study. 5. Male or Eligible Female Subjects: To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (see Appendix 2 of protocol) for the duration of the trial and for 4 months after the last study drug administration. A serum pregnancy test is required of all females. at the initial Screening Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to Visit 2, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1. Immunogenicity: Positive neutralizing antibody status based on the last sample obtained during the MEA 112997 study. 2. Hypersensitivity: Report of a hypersensitivity reaction assessed as related to mepolizumab that led to patient withdrawal. Subjects who experienced a localized injection-site reaction do not need to be excluded. 3. Health Status: Clinically significant change in health status since completing participation in the MEA112997 trial which in the opinion of the investigator would make the subject unsuitable for participation in this long term study. 4. Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: · known ejection fraction of 450msec or QTcF >480msec for subjects with Bundle Branch Block. 9. Xolair: Received Xolair (omalizumab) within the past 130 days 10. Clinical trial: Participated in a clinical trial within the past 30 days or have received investigational medication within five terminal half-lives of Screen Visit,whichever is longer. 11. Smoking status: Current smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to describe the long-term safety profile of mepolizumab. ;Secondary Objective: To evaluate the effects of mepolizumab on a range of clinical markers of asthma control;Primary end point(s): Adverse Events;Timepoint(s) of evaluation of this end point: Interim data analysis will occur at least yearly. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Frequency of positive anti-mepolizumab binding antibodies and neutralizing antibodies • Annualized rate of exacerbations • Asthma Control Questionnaire score • FEV1 measured by clinic spirometry • Number of withdrawals due to lack of efficacy • Number of withdrawals due to adverse events • Number of hospitalizations due to adverse events including asthma exacerbations • Frequency of both systemic (ie, allergic/IgE-mediated and non-allergic) and local site reactions • 12 Lead ECG parameters • Vital signs • Clinical Laboratory Parameters ;Timepoint(s) of evaluation of this end point: Interim data analysis will occur at least yearly. | — |
Countries
Argentina, Australia, Canada, Chile, France, Germany, Korea, Republic of, Poland, Romania, Russian Federation, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed