A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:8/8/2018
Start Date:May 27, 2013
End Date:March 13, 2015

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A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials

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.


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
We found this trial at
21
sites
New York, New York 10032
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Albany, Georgia 31707
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Albany, GA
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Baltimore, Maryland 21201
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Baltimore, MD
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Cleveland, Ohio 44195
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Cleveland, OH
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Denver, Colorado 80206
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Denver, CO
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Durham, North Carolina 27705
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Durham, NC
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Hershey, Pennsylvania 17033
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Hershey, PA
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Long Beach, California 90813
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Mar del Plata, Buenos Aires
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Mar del Plata,
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Nashville, Tennessee 37203
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Nashville, TN
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New Haven, Connecticut 06520
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New Haven, CT
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Newport Beach, California 92663
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Riverside, California 92506
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Riverside, CA
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Rochester, Minnesota 55905
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Rochester, MN
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Rochester, New York 14642
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Rochester, NY
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Rolling Hills Estates, California 90274
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Rolling Hills Estates, CA
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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