severe eosinophilic asthma MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if ALL of the following criteria apply: 1. Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent, and an assent for subjects under 18 years of age, at Visit 0 (or Visit 1 if these Visits are conducted on the same day). 2. Continuous Mepolizumab Treatment during MEA115666 or 201312: Participation through the Follow Up/Exit Visit or Early Withdrawal Visit and documented evidence of treatment with mepolizumab with no treatment gaps of more than 12 weeks (84 days) between any two doses within MEA115666 or 201312. (A treatment gap of more than 12 weeks [84 days] cannot occur between the end of MEA115666 or 201312 and Visit 1). 3. 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. 4. Male or Eligible Female Subjects: A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, > 45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to acceptable contraceptive methods approved in their local country, when used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician) for the duration of the study and for 4 months after the last study drug administration (see Appendix 5). A urine pregnancy test is required of all females of child-bearing potential at each scheduled study visit prior to the injection of study treatment, and at the Exit Visit, EW or Discontinuation of IP Visit. 5. 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? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 235 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if ANY of the following criteria apply: 1. MEA115666 or 201312 IP Discontinuation: Subjects withdrawn from IP or withdrawn from study participation from either MEA115666 or 201312 for safety reasons 2. Health Status: Clinically significant deterioration in health status at the completion of participation or EW from either the MEA115666 or 201312 trials which in the opinion of the investigator would make the subject unsuitable for participation in this study. 3. Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation. 4. Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: - known ejection fraction of 450 msec, or - QTcF >480 msec for subjects with Bundle Branch Block. 6. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). [Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded]. 7. Other Monoclonal Antibodies: Subjects who have received any monoclonal antibody within 5 half-lives of Visit 1. 8. Adherence: Subjects who have known evidence of lack of adherence within studies MEA115666 or 201312 (less than 80%) to controller medications, scheduled study visits and/or ability to follow physician’s recommendations. 9. Smoking status: Current smokers 10. Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete a questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether patients with severe eosinophilic asthma who have received longterm treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit.;Secondary Objective: To assess the safety and tolerability of mepolizumab continuation compared to placebo following long-term treatment with mepolizumab in patients with severe eosinophilic asthma.;Primary end point(s): -Time to first clinically significant exacerbation;Timepoint(s) of evaluation of this end point: - Time to first clinically significant exacerbation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Ratio to baseline in blood eosinophil count at weeks 12, 24, 36 and 52 • Time to a decrease in asthma control, defined as an increase from baseline in Asthma Control Questionnaire-5 (ACQ-5) score of = 0.5 units • Time to first exacerbation requiring hospitalization or ED visit ;Timepoint(s) of evaluation of this end point: Refer to E.5.2 | — |
Countries
Argentina, Australia, Canada, Chile, Germany, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Ukraine, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed