A Long-term Access Programme for Subjects With Severe Asthma

Asthma Clinical Trial

Official title:

A Long-term Access Programme for Subjects With Severe Asthma Who Participated in a GSK-sponsored Mepolizumab Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02543112
• Other study ID #: 201956
• Status: Recruiting
• Phase: Phase 3
• First received: July 9, 2015
• Last updated: April 13, 2017
• Start date: August 3, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2017
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

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

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treatment period in the mepolizumab asthma clinical study to which they were originally enrolled or if the subject was withdrawn from study treatment prematurely during the mepolizumab asthma clinical study to which they were originally enrolled but the subject has completed the study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

• The treating physician requesting mepolizumab under this Long-term Access Programme considers the benefits of treatment with mepolizumab outweigh the risks for the individual 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 of an acceptable method of birth control, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.

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

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 skin which was resected for cure will not be excluded).

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

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

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

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

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

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

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mepolizumab 40mg or 100mg
Mepolizumab will be provided as a lyopholised cake in sterile vials. Lyophilized powder for injection will be reconstituted with Sterile Water for Injection, just prior to use.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	La Plata	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	San Rafael	Mendoza
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Erpent
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	St-Charles-Borromée	Quebec
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Windsor	Ontario
Czech Republic	GSK Investigational Site	Hlucin
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Kralupy nad Vltavou
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Plzen
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Brest Cedex
France	GSK Investigational Site	Dijon Cedex
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Lyon cedex 04
France	GSK Investigational Site	Marseille Cedex 20
France	GSK Investigational Site	Montpellier cedex 5
France	GSK Investigational Site	Nantes cedex 1
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Pessac cedex
France	GSK Investigational Site	Reims Cedex
Germany	GSK Investigational Site	Bamberg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Schleswig	Schleswig-Holstein
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Haidari / Athens
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Foggia	Puglia
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Leeuwarden
Netherlands	GSK Investigational Site	Leiden
Netherlands	GSK Investigational Site	Rotterdam
Norway	GSK Investigational Site	Bergen
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima 27	Lima
Peru	GSK Investigational Site	San Martin de Porres	Lima
Peru	GSK Investigational Site	San Miguel	Lima
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Irkutsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Saint Petesburg
Russian Federation	GSK Investigational Site	St'Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Stavropol
Russian Federation	GSK Investigational Site	Voronezh
Slovakia	GSK Investigational Site	Sala
Slovakia	GSK Investigational Site	Spisska Nova Ves
Slovakia	GSK Investigational Site	Vrable
Spain	GSK Investigational Site	Alcorcón (Madrid)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Pozuelo de Alarcón/Madrid
Spain	GSK Investigational Site	Santander
Spain	GSK Investigational Site	Santiago de Compostela. La Coruña.
Spain	GSK Investigational Site	Valencia
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Vinnytsia
United Kingdom	GSK Investigational Site	Bradford
United Kingdom	GSK Investigational Site	Oxford
United Kingdom	GSK Investigational Site	Plymouth
United Kingdom	GSK Investigational Site	Swansea
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Rolling Hills Estates	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Canada,  Czech Republic,  Estonia,  France,  Germany,  Greece,  Italy,  Netherlands,  Norway,  Peru,  Russian Federation,  Slovakia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Serious Adverse Events as a measure of safety and tolerability	Based on regular standard-of-care management at each visit (includes assessment of SAEs), an overall assessment of benefit versus risk will be performed prior to mepolizumab administration.	Up to Follow-up (addressed up to 4 years)