Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT03298061
• Date of registration: 27/09/2017
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Long-term Access Program (LAP) of Mepolizumab 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: April 14, 2015
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03298061
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject participated in study MEA115921.

- Subject has either: a) completed study MEA115921 to Week 60, that is, completion of
follow up period, or b) if the subject was withdrawn prematurely from study MEA115921,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, that is, 60 weeks from Baseline (Visit 2).

- 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.

- The treating physician requesting mepolizumab under this LAP considers the benefits of
treatment with mepolizumab outweigh the risks for the individual subject.

- To be eligible for mepolizumab treatment under this LAP, 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 LAP.

Exclusion Criteria:

- A current malignancy or history of cancer in remission for less than 12 months
(Subjects who had localized carcinoma (that is, 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 EGPA, example, 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 study MEA115921 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 therapy without prior agreement
from the GSK Medical Monitor.

- 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 LAP (this also includes investigational
formulations of marketed products).

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Churg-Strauss Syndrome

Eosinophilic Granulomatosis With Polyangiitis

Intervention(s)

Drug: Prednisolone

Drug: Mepolizumab

Primary Outcome(s)

Number of subjects with corticosteroid use [Time Frame: Up to 3 years approximately]

Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [Time Frame: Up to 3 years approximately]

Secondary ID(s)

116841

2014-003162-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors