201956: A LONG-TERM ACCESS PROGRAMME FOR SUBJECTS WITH SEVERE ASTHMA WHO PARTICIPATED IN A GSK-SPONSORED MEPOLIZUMAB CLINICAL STUDY

Not Applicable

Completed

• Conditions: -J45; J45

• Registration Number: PER-067-15
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-28
• Study Completion: 2022-08-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

1.Subject participated in GSK-sponsored asthma clinical study with mepolizumab as specified in Appendix 1
2.Subject has either:
i.completed the treatment period in the mepolizumab asthma clinical study to which they were originally enrolled
or
ii.if the subject was withdrawn from study treatment prematurely during the mepolizumab asthma clinical study to which they were originally enrolled but the subject has completed the study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.
3.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.
4.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, as summarised in Appendix 4, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.
5.The subject consents to receiving treatment with mepolizumab under this Long-term Access Programme.

Exclusion Criteria

1.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).
2.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.
3.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.
4.Subject has a known allergy or intolerance to a monoclonal antibody or biologic therapy including mepolizumab.
5.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.
6.Subject is receiving treatment with another biological therapy such as a monoclonal antibody therapy or intravenous (IV) immunoglobulin (Ig) therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified