MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
NCT ID: NCT01691859
Last Updated: 2023-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
347 participants
INTERVENTIONAL
2012-09-28
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mepolizumab
Subjects will receive 100 mg of mepolizumab (in 1ml polypropylene syringe) injected subcutaneously (SC) approximately every 4 weeks.
Mepolizumab
100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks
Interventions
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Mepolizumab
100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Riverside, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
New Haven, Connecticut, United States
GSK Investigational Site
Albany, Georgia, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Hershey, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Mendoza, , Argentina
GSK Investigational Site
New Lambton, New South Wales, Australia
GSK Investigational Site
Adelaide, South Australia, Australia
GSK Investigational Site
Clayton, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Nedlands, Western Australia, Australia
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Mississauga, Ontario, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Valparaíso, Región de Valparaíso, Chile
GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, , Chile
GSK Investigational Site
Talcahuano, , Chile
GSK Investigational Site
Le Kremlin-Bicêtre, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Saint-Pierre, , France
GSK Investigational Site
Rüdersdorf, Brandenburg, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Magdeburg, , Germany
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Wroclaw, , Poland
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Iași, , Romania
GSK Investigational Site
Târgu Mureş, , Romania
GSK Investigational Site
Barnaul, , Russia
GSK Investigational Site
Chelyabinsk, , Russia
GSK Investigational Site
Kazan', , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
St'Petersburg, , Russia
GSK Investigational Site
Cheongju, Chungcheongbuk-do, , South Korea
GSK Investigational Site
Suwon, Kyonggi-do, , South Korea
GSK Investigational Site
Dnipropetrovsk, , Ukraine
GSK Investigational Site
Donetsk, , Ukraine
GSK Investigational Site
Kharkiv, , Ukraine
GSK Investigational Site
Kiev, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Leicester, Leicestershire, United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
Southampton, , United Kingdom
Countries
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References
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Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, Bradford ES, Gilson M, Price RG, Yancey SW, 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. 2019 May;143(5):1742-1751.e7. doi: 10.1016/j.jaci.2018.09.033. Epub 2018 Oct 23.
Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-001643-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
115666
Identifier Type: -
Identifier Source: org_study_id
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