Last updated: 07/17/2024 15:49:00
MEA112997 Open-label long term extension safety study of mepolizumab in asthmatic subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: MEA115666: A multi-centre, open-label, long term safety study of mepolizumab in asthmatic subjects who participated in the MEA112997 trial
Trial description: This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants who experienced on-treatment adverse events (AE) and on-treatment serious adverse events (SAE)
Timeframe: Baseline (Week 0) to Week 240
Secondary outcomes:
Number of participants who experienced on-treatment systemic (i.e., allergic/Immunoglobulin E [IgE]-mediated and non-allergic) and on-treatment local site reactions
Timeframe: Baseline (Week 0) to Week 240
Mean change from Baseline in QT interval corrected by Bazett's method (QTc[B])
Timeframe: Baseline (Week 0) to Week 240
Mean change from Baseline in QT interval corrected by Fridericia's method (QTc[F])
Timeframe: Baseline (Week 0) to Week 240
Number of participants with a maximum change from Baseline for QTc(F) and QTc(B)
Timeframe: Baseline (Week 0) to Week 240
Number of participants with clinical chemistry data of potential clinical concern
Timeframe: Baseline (Week 0) to Week 240
Number of participants with hematology data of potential clinical concern
Timeframe: Baseline (Week 0) to Week 240
Mean change from Baseline in vital signs-Sitting diastolic blood pressure and sitting systolic blood pressure
Timeframe: Baseline (Week 0) to Week 240
Mean change from Baseline in Vital signs-Sitting pulse rate
Timeframe: Baseline (Week 0) to Week 240
Annualized rate of on-treatment exacerbations
Timeframe: Baseline (Week 0) to Week 240
Mean change from Baseline in Asthma Control Questionnaire (ACQ) score
Timeframe: Baseline (Week 0) to Week 240
Mean change from Baseline in clinic pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Timeframe: Baseline (Week 0) to Week 240
Number of participants with positive anti-mepolizumab binding antibodies (ADA) and neutralizing antibodies (NAb)
Timeframe: Baseline (Week 0) to Week 240
Number of participants who withdrew due to lack of efficacy
Timeframe: Baseline (Week 0) to Week 240
Number of participants requiring hospitalizations due to adverse events including asthma exacerbations
Timeframe: Baseline (Week 0) to Week 240
Number of participants who withdrew due to AE
Timeframe: Baseline (Week 0) to Week 240
Interventions:
Enrollment:
347
Primary completion date:
2017-31-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Khatri S, Moore W, Gibson P, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Albers F, Bradford E, Gilson M, Price R, Howarth P, Yancey S, Ortega H. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2018;143(5):1742-1751
DOI: 10.1016/j.jaci.2018.09.033
PMID: 30359681
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
September 2012 to May 2017
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Informed Consent.
- MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial.
- Hypersensitivity related to mepolizumab.
- Clinically significant change in health status since completing participation in the MEA112997 trial.
Inclusion and exclusion criteria
Inclusion criteria:
- Informed Consent.
- MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial.
- MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio.
- Currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks.
- 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.
Exclusion criteria:
- Hypersensitivity related to mepolizumab.
- Clinically significant change in health status since completing participation in the MEA112997 trial.
- A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
- For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator.
- Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
- Screening ECG which has a clinically significant abnormality.
- Received Xolair (omalizumab) within the past 130 days.
- 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.
- Current smokers.
Trial location(s)
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Cheongju, Chungcheongbuk-do, South Korea, 361-711
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
Status
Study Complete
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Study Complete
Location
GSK Investigational Site
Le Kremlin-Bicêtre Cedex, France, 94275
Status
Study Complete
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40508
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06520
Status
Study Complete
Location
GSK Investigational Site
New Lambton, New South Wales, Australia, 2305
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, ValparaÃso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
Study complete
Actual primary completion date
2017-31-05
Actual study completion date
2017-31-05
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
Additional information
Not applicable
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