Last updated: 07/17/2024 15:49:00

MEA112997 Open-label long term extension safety study of mepolizumab in asthmatic subjects

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GSK study ID
115666
See study documents
Clinicaltrials.gov ID
NCT01691859
See results summary
EudraCT ID
2012-001643-51
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Drug: Mepolizumab
    • 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
    Status
    Contact us
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    Location
    GSK Investigational Site
    Adelaide, South Australia, Australia, 5000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albany, Georgia, United States, 31707
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barnaul, Russia, 656 045
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10367
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10717
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bucharest, Romania, 011461
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    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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