A Long-term Access Programme for Subjects With Severe Asthma

Last updated: April 13, 2017
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT02543112
201956
  • Ages > 6
  • All Genders

Study Summary

This is a Long-term Access Programme (LAP) which aims to support provision of mepolizumab, until it is commercially available, to eligible subjects with severe asthma who participated in a GSK-sponsored mepolizumab clinical study 200862 and 200363. Eligible subjects will initiate mepolizumab within a 6-month period following the individual subject's last scheduled visit in their preceding clinical study. For each subject benefit versus risk will be assessed throughout the study to support continued treatment with mepolizumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject participated in GSK-sponsored asthma clinical study with mepolizumab asspecified in Study 200862 and 200363

  • Subject has either: completed the treatment period in the mepolizumab asthma clinicalstudy to which they were originally enrolled or if the subject was withdrawn fromstudy treatment prematurely during the mepolizumab asthma clinical study to whichthey were originally enrolled but the subject has completed the study assessments atthe study visit that would have been the end of the respective treatment period.

  • The treating physician requesting mepolizumab under this Long-term Access Programmeconsiders the benefits of treatment with mepolizumab outweigh the risks for theindividual subject.

  • To be eligible for mepolizumab treatment under this Long-term Access Programme,females of childbearing potential (FCBP) must commit to consistent and correct use ofan acceptable method of birth control, beginning with consent, for the duration ofthe treatment with mepolizumab and for 4 months after the last mepolizumabadministration.

  • The subject consents to receiving treatment with mepolizumab under this Long-termAccess Programme. In the case of a paediatric subject being eligible aparent(s)/guardian will give written informed consent prior to the child'sparticipation in the study. If applicable, the subject must be able and willing togive assent to take part in the study according to the local requirement.

Exclusion

Exclusion Criteria:

  • A current malignancy or history of cancer in remission for less than 12 months (Subjects who had localized carcinoma (i.e., basal or squamous cell) of the skinwhich was resected for cure will not be excluded).

  • Subject has other clinically significant medical conditions uncontrolled withstandard-of-care therapy not associated with asthma, e.g., unstable liver disease,uncontrolled cardiovascular disease, ongoing active infectious disease requiringsystemic treatment.

  • Subject is pregnant or breastfeeding. Subjects should not be considered for continuedtreatment if they plan to become pregnant during the course of treatment withmepolizumab.

  • Subject has a known allergy or intolerance to a monoclonal antibody or biologictherapy including mepolizumab.

  • Subject had an adverse event (serious or non-serious) considered related to studytreatment whilst participating in a clinical study with mepolizumab which resulted inpermanent withdrawal of study treatment.

  • Subject is receiving treatment with another biological therapy such as a monoclonalantibody therapy or intravenous (IV) immunoglobulin (Ig) therapy.

  • Subjects who have received treatment with an investigational drug within the past 30days or 5 terminal phase half-lives of the drug whichever is longer, prior toinitiation of mepolizumab treatment under this Long-term Access Programme (this alsoincludes investigational formulations of marketed products).

  • Subject is currently participating in any other interventional clinical study.

Study Design

Total Participants: 500
Study Start date:
August 03, 2015
Estimated Completion Date:
December 31, 2019

Connect with a study center

  • GSK Investigational Site

    La Plata, Buenos Aires 1900
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mar del Plata, Buenos Aires 7600
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    San Rafael, Mendoza 5600
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario, Santa Fe S2000JKR
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Buenos Aires, C1425BEN
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, C1121ABE
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Brussels, 1000
    Belgium

    Completed

  • GSK Investigational Site

    Erpent, 5101
    Belgium

    Completed

  • GSK Investigational Site

    Gent, 9000
    Belgium

    Completed

  • GSK Investigational Site

    Leuven, 3000
    Belgium

    Completed

  • GSK Investigational Site

    Liège, 4000
    Belgium

    Completed

  • GSK Investigational Site

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • GSK Investigational Site

    Sofia, 1431
    Bulgaria

    Completed

  • GSK Investigational Site

    Calgary, Alberta T2N 4Z6
    Canada

    Completed

  • GSK Investigational Site

    Vancouver, British Columbia V5Z 1M9
    Canada

    Completed

  • GSK Investigational Site

    Windsor, Ontario N8X 5A6
    Canada

    Completed

  • GSK Investigational Site

    Montreal, Quebec H4J 1C5
    Canada

    Completed

  • GSK Investigational Site

    Sainte-Foy, Quebec G1V 4G5
    Canada

    Completed

  • GSK Investigational Site

    St-Charles-Borromée, Quebec J6E 2B4
    Canada

    Completed

  • GSK Investigational Site

    Hlucin, 748 01
    Czech Republic

    Active - Recruiting

  • GSK Investigational Site

    Hradec Kralove, 500 05
    Czech Republic

    Active - Recruiting

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01
    Czech Republic

    Active - Recruiting

  • GSK Investigational Site

    Olomouc, 775 20
    Czech Republic

    Active - Recruiting

  • GSK Investigational Site

    Plzen, 305 99
    Czech Republic

    Active - Recruiting

  • GSK Investigational Site

    Tallinn, 13419
    Estonia

    Active - Recruiting

  • GSK Investigational Site

    Tartu, 51014
    Estonia

    Completed

  • GSK Investigational Site

    Brest Cedex, 29609
    France

    Active - Recruiting

  • GSK Investigational Site

    Dijon Cedex, 21033
    France

    Active - Recruiting

  • GSK Investigational Site

    Lille cedex, 59037
    France

    Active - Recruiting

  • GSK Investigational Site

    Lyon cedex 04, 69317
    France

    Active - Recruiting

  • GSK Investigational Site

    Marseille Cedex 20, 13915
    France

    Active - Recruiting

  • GSK Investigational Site

    Montpellier cedex 5, 34295
    France

    Active - Recruiting

  • GSK Investigational Site

    Nantes cedex 1, 44093
    France

    Active - Recruiting

  • GSK Investigational Site

    Paris Cedex 18, 75877
    France

    Active - Recruiting

  • GSK Investigational Site

    Pessac cedex, 33604
    France

    Active - Recruiting

  • GSK Investigational Site

    Reims Cedex, 51092
    France

    Active - Recruiting

  • GSK Investigational Site

    Bamberg, Bayern 96049
    Germany

    Completed

  • GSK Investigational Site

    Koblenz, Rheinland-Pfalz 56068
    Germany

    Completed

  • GSK Investigational Site

    Leipzig, Sachsen 04357
    Germany

    Completed

  • GSK Investigational Site

    Schleswig, Schleswig-Holstein 24837
    Germany

    Completed

  • GSK Investigational Site

    Berlin, 12203
    Germany

    Completed

  • GSK Investigational Site

    Hamburg, 22299
    Germany

    Terminated

  • GSK Investigational Site

    Athens, 106 76
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Haidari / Athens, 124 62
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Thessaloniki, 56403
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Parma, Emilia-Romagna 43125
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Bari, Puglia 70124
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Foggia, Puglia 71100
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Firenze, Toscana 50134
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Amsterdam, 1105 AZ
    Netherlands

    Completed

  • GSK Investigational Site

    Breda, 4818 CK
    Netherlands

    Completed

  • GSK Investigational Site

    Leeuwarden, 8934 AD
    Netherlands

    Completed

  • GSK Investigational Site

    Leiden, 2333 ZA
    Netherlands

    Completed

  • GSK Investigational Site

    Rotterdam, 3045 PM
    Netherlands

    Completed

  • GSK Investigational Site

    Bergen, 5021
    Norway

    Active - Recruiting

  • GSK Investigational Site

    Lima 27, Lima Lima 27
    Peru

    Active - Recruiting

  • GSK Investigational Site

    San Martin de Porres, Lima Lima 31
    Peru

    Active - Recruiting

  • GSK Investigational Site

    San Miguel, Lima Lima 32
    Peru

    Active - Recruiting

  • GSK Investigational Site

    Lima, Lima 1
    Peru

    Active - Recruiting

  • GSK Investigational Site

    Ekaterinburg, 620 109
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Irkutsk, 664043
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Moscow, 115409
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Novosibirsk, 630102
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Saint Petesburg, 195030
    Russian Federation

    Completed

  • GSK Investigational Site

    St'Petersburg, 197706
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    St. Petersburg, 198216
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Stavropol, 355017
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Voronezh, 394066
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Sala, 927 01
    Slovakia

    Active - Recruiting

  • GSK Investigational Site

    Spisska Nova Ves, 052 01
    Slovakia

    Active - Recruiting

  • GSK Investigational Site

    Vrable, 952 01
    Slovakia

    Completed

  • GSK Investigational Site

    Alcorcón (Madrid), 28922
    Spain

    Completed

  • GSK Investigational Site

    Madrid, 28041
    Spain

    Completed

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223
    Spain

    Completed

  • GSK Investigational Site

    Santander, 39008
    Spain

    Completed

  • GSK Investigational Site

    Santiago de Compostela. La Coruña., 15706
    Spain

    Completed

  • GSK Investigational Site

    Valencia, 46026
    Spain

    Completed

  • GSK Investigational Site

    Dnipropetrovsk, 49051
    Ukraine

    Active - Recruiting

  • GSK Investigational Site

    Kharkiv, 61124
    Ukraine

    Active - Recruiting

  • GSK Investigational Site

    Kyiv, 03680
    Ukraine

    Active - Recruiting

  • GSK Investigational Site

    Vinnytsia, 21029
    Ukraine

    Active - Recruiting

  • GSK Investigational Site

    Bradford, BD96RJ
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Oxford, OX37LE
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Swansea, SA2 8PP
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Rolling Hills Estates, California 90274
    United States

    Completed

  • GSK Investigational Site

    Baltimore, Maryland 21236
    United States

    Completed

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