Last updated: 11/07/2018 09:46:14
A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in theMEA115588 or MEA115575 trials
Trial description: This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs) including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions
Timeframe: From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])
Secondary outcomes:
Number of participants with positive anti-mepolizumab binding antibodies and neutralizing antibodies (NAb) at the indicated time points
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Annualized rate of exacerbations per year
Timeframe: Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose
Mean change from Baseline in asthma control questionnaire (ACQ) score
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Mean change from Baseline in clinic pre-bronchodilator FEV1 over the 52-week treatment period
Timeframe: From Baseline and up to Week 52
Number of participants withdrawn due to lack of efficacy and adverse events from the study
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Number of participants hospitalized due to exacerbations and adverse events
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Number of participants with systemic (i.e., allergic/IgE-mediated and non-allergic) and local site reactions
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Number of participants with electrocardiogram (ECG) findings at any time post Baseline
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Mean change from Baseline in QT interval corrected by Bazett's method (QTcB) and QT interval corrected by Fridericia's method (QTcF) values for ECG assessed at Baseline, Week 28, Week 52 and at follow-up visit (approx. 12 weeks post-last dose)
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Number of participants with maximum change from Baseline in QTcF interval for ECG assessed at any time post Baseline
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Number of participants with maximum change from Baseline in QTcB interval for ECG assessed at any time post Baseline
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Change from Baseline in systolic blood pressure and diastolic blood pressure assessed at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in pulse rate assessed at Week 52
Timeframe: Baseline and Week 52
Number of participants with clinical chemistry parameters outside the normal range at any time post-baseline
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Number of participants with haematology laboratory parameters outside the normal range at any time post-baseline
Timeframe: From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
Interventions:
Biological/vaccine: Mepolizumab
Enrollment:
651
Observational study model:
Not applicable
Primary completion date:
2015-13-03
Time perspective:
Not applicable
Clinical publications:
Lugogo N, Domingo Ribas C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma: a multi-center open-label, phase IIIb study. Clin Ther. 2016;38:2058-2070
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
May 2013 to March 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- 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.
- Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
- Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
- Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
- Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent.
- MEA115588 or MEA115575 study completion: Completion of the double-blind investigational product treatment during MEA115588 or MEA115575.
- Current Anti-Asthma Therapy: Asthma is currently being treated with a controller medication (i.e., inhaled corticosteroids [ICS] or other asthma controlled 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.
- 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 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 Baseline Visit (Visit 1). In addition, a urine pregnancy test will be performed for all females prior to enrollment, during each scheduled study visit prior to the injection of investigational product, and during the Follow-up Visit.
Exclusion criteria:
- Hypersensitivity: Hypersensitivity reaction related to study medication during the MEA115588 or MEA115575 that led to patient withdrawal. Subjects who experienced a localized injection site reaction do not need to be excluded.
- Health Status: Clinically significant change in health status during MEA115588 or MEA115575 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study.
- Malignancy: A current malignancy or malignancy that developed during MEA115588 or MEA115575 (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]
- Prior SAE: A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator.
- Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
- ECG: Baseline ECG which has a clinically significant abnormality or which shows corrected QT interval with Fridericia (QTcF) >=450 millisecond (msec) or QTcF >=480 msec for subjects with Bundle Branch Block.
- Smoking status: Current smokers
- Liver Function: Liver function tests that meet any of the following during one of the last treatment visits in MEA115588 or MEA115575 : alanine transaminase (ALT) >=2 x upper limit of normal (ULN); aspartate transaminase (AST) >=2 x ULN; alkaline phosphatase >=2 x ULN; Bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%
- Hepatitis Status: Positive Hepatitis B Surface Antigen (HBsAg) screen at Visit 1
- ECG Over-read: Clinically significant abnormality identified during the central over-read during one of the last treatment visits in MEA115588 or MEA115575
Trial location(s)
Location
GSK Investigational Site
Le Kremlin-Bicêtre Cedex, France, 94275
Status
Study Complete
Location
GSK Investigational Site
Pittsburg, Pennsylvania, United States, PA 15213
Status
Study Complete
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06520
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27704
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14642
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DBS
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
Status
Study Complete
Location
GSK Investigational Site
Pietra Ligure (SV), Liguria, Italy, 17027
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1424BSF
Status
Study Complete
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Study Complete
Location
GSK Investigational Site
Rancagua, Reg Del Libert Bern Ohiggins, Chile, 2841959
Status
Study Complete
Location
GSK Investigational Site
St-Charles-Borromée, Québec, Canada, J6E 2B4
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
Status
Study Complete
Location
GSK Investigational Site
New Lambton, New South Wales, Australia, 2310
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Cheongju, Chungcheongbuk-do, South Korea, 361-711
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Status
Study Complete
Location
GSK Investigational Site
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-13-03
Actual study completion date
2015-13-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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