A Long-term Access Programme for Asthmatic Subjects who Participated in a Clinical Study with Mepolizumab

• Conditions: Subjects with severe asthma; MedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001152-29-NL
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

A subject will be eligible for the LAP only if all of the following criteria apply:

[1] CLINICAL STUDY PARTICIPATION
Subject participated in GSK-sponsored asthma clinical study with mepolizumab as specified in Appendix 2(page 35 - Protocol v00/13 May 2015).

[2] STUDY COMPLETION
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 if the subject was withdrawn from study treatment prematurely during the mepolizumab asthma clinical study to which they were originally enrolled but the subject has completed the study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] PHYSICIAN ASSESSMENT SUPPORTS MEPOLIZUMAB TREATMENT
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] FEMALE SUBJECTS
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 (page 37 - Protocol v00, 13 May 2015), beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.

[5] INFORMED CONSENT
5. 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

A subject will not be eligible for the LAP if any of the following criteria apply:

[1] MALIGNANCY
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] OTHER CLINICALLY SIGNIFICANT MEDICAL CONDITIONS
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] PREGNANCY
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] HYPERSENSITIVITY
4. Subject has a known allergy or intolerance to a monoclonal antibody or biologic therapy including mepolizumab.

[5] PREMATURE WITHDRAWAL OF STUDY TREATMENT
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] OTHER BIOLOGICAL THERAPY
6. Subject is receiving treatment with another biological therapy such as a monoclonal antibody therapy or intravenous (IV) immunoglobulin (Ig) therapy.

[7] OTHER INVESTIGATIONAL PRODUCTS
7. 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).

[8] OTHER CLINICAL STUDY
8. Subject is currently participating in any other interventional clinical study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSKsponsored mepolizumab study.;Secondary Objective: Not applicable;Primary end point(s): Not applicable since this study is a long term access programme (no endpoints included in the protocol);Timepoint(s) of evaluation of this end point: Not applicable since this study is a long term access programme.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable since this study is a long term access programme.;Timepoint(s) of evaluation of this end point: Not applicable since this study is a long term access programme.