Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2014-003162-25-GB
• Date of registration: 22/01/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Research Ltd
• Public title: Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921
• Scientific title: Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)
• Date of first enrolment: 19/03/2015
• Target sample size: 42
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003162-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, France, Germany, Japan, United Kingdom

Contacts

• Name: Clinical Trials HelpDesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

• Name: Clinical Trials HelpDesk
• Affiliation: GlaxoSmithKline Research & Development Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
[1] MEA115921 PARTICIPATION
1. Subject participated in study MEA115921

[2] MEA115921 COMPLETION
2. Subject has either:
i. completed study MEA115921 to Week 60, i.e., completion of follow up period,
or
ii. if the subject was withdrawn prematurely from study MEA115921, the subject has reached the date of what would have been the Week 60 if the subject had completed the study, i.e., 60 weeks from Baseline (Visit 2).

[3] SUBJECT REQUIRES PREDNISOLONE (OR EQUIVALENT)=>5 MG/DAY
3. At or up to 6 months after the MEA115921 Week 60 time- point the subject requires a dose of prednisolone (or equivalent) of =>5 mg/day for adequate control of their EGPA.
Note: Inclusion of subjects >6 months after the MEA115921 Week 60 time-point will be considered on an individual subject basis by the GSK Medical Monitor.

[4] PHYSICIAN ASSESSMENT SUPPORTS MEPOLIZUMAB TREATMENT
4. 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.

[5] FEMALE SUBJECTS
5. 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 3, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.

[6] INFORMED CONSENT
6. The subject consents to receiving treatment with mepolizumab under this Long-term Access Programme.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
[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 standardof- care therapy not associated with EGPA, 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 IN MEA115921
5. Subject had an adverse event (serious or non-serious) considered related to study treatment whilst participating in study MEA115921 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 IV immunoglobulin 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome)
MedDRA version: 20.0 Level: LLT Classification code 10018701 Term: Granulomatous disease System Organ Class: 100000004867
MedDRA version: 20.0 Level: LLT Classification code 10014956 Term: Eosinophilic granuloma System Organ Class: 100000004864
MedDRA version: 20.0 Level: LLT Classification code 10072580 Term: Granulomatous polyangiitis System Organ Class: 100000004866
MedDRA version: 20.1 Level: LLT Classification code 10014957 Term: Eosinophilic granulomatous vasculitis System Organ Class: 100000004870
MedDRA version: 20.0 Level: LLT Classification code 10056218 Term: Necrotising granulomatous vasculitis System Organ Class: 100000004866
MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10036023 Term: Polyangiitis System Organ Class: 100000004866

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: SB-240563 (mepolizumab)
Product Code: SB-240563 (mepolizumab)
Pharmaceutical Form: Injection
INN or Proposed INN: Mepolizumab
CAS Number: 196078-29-2
Current Sponsor code: SB-240563
Other descriptive name: MEPOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): N/A

Timepoint(s) of evaluation of this end point: N/A

Main Objective: The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible subjects who previously participated in GSKsponsored study MEA115921.

Secondary Objective: N/A

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

MEA116841

2014-003162-25-DE

Source(s) of Monetary Support

GSK R&D

Ethics review

Status: Approved
Approval date:
Contact: