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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03298061

Collaborator

(none)

104

Enrollment

Locations

Arm

95.5

Anticipated Duration (Months)

3.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody, therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921 was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8 weeks to study completion at Week 60. This is a LAP to support provision of open-label mepolizumab on an individual basis to eligible subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under this LAP within a 6-month period starting from completion of study MEA115921 (that is, at Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will initiate mepolizumab at the time point that would have been Week 60 if the subject had completed the study. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject meets any of the withdrawal/stopping criteria.

Condition or Disease	Intervention/Treatment	Phase
Churg-Strauss Syndrome	Drug: Mepolizumab Drug: Prednisolone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Subjects who participated in clinical study MEA115921 and require a dose of prednisolone (or equivalent) of >=5 mg/day for adequate control of their EGPA will be included in this study based on the confirmation of their eligibility by GSK Medical Monitor. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks.Subjects who participated in clinical study MEA115921 and require a dose of prednisolone (or equivalent) of >=5 mg/day for adequate control of their EGPA will be included in this study based on the confirmation of their eligibility by GSK Medical Monitor. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Actual Study Start Date :

Apr 14, 2015

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects from clinical study MEA115921 Subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks.	Drug: Mepolizumab Mepolizumab will be available as lyophilized powder for injection to be reconstituted with sterile water for injection, prior to use. Subjects will be dosed with mepolizumab at a dose of 300 mg which will be administered as three separate 100 mg SC injections every 4 weeks. The injections will be administered into any of the upper arm, thigh or anterior abdominal wall. Drug: Prednisolone Subjects who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included.

Arm

Intervention/Treatment

Experimental: Subjects from clinical study MEA115921

Subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks.

Drug: Mepolizumab

Mepolizumab will be available as lyophilized powder for injection to be reconstituted with sterile water for injection, prior to use. Subjects will be dosed with mepolizumab at a dose of 300 mg which will be administered as three separate 100 mg SC injections every 4 weeks. The injections will be administered into any of the upper arm, thigh or anterior abdominal wall.

Drug: Prednisolone

Subjects who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included.

Outcome Measures

Primary Outcome Measures

Number of subjects with corticosteroid use [Up to 3 years approximately]
The use of corticosteroids excluding inhaled and topical steroids will be summarized.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [Up to 3 years approximately]
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events based on medical or scientific judgment; and is associated with liver injury and impaired liver function. Additionally, systemic (that is, allergic/hypersensitivity and non-allergic) reactions and local injection site reactions will be recorded throughout the treatment and follow-up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Denver	Colorado	United States	80206
2	GSK Investigational Site	Bethesda	Maryland	United States	20892
3	GSK Investigational Site	Boston	Massachusetts	United States	02118-2307
4	GSK Investigational Site	Boston	Massachusetts	United States	02215
5	GSK Investigational Site	Saint Louis	Missouri	United States	63110
6	GSK Investigational Site	New York	New York	United States	10021
7	GSK Investigational Site	Cleveland	Ohio	United States	44195
8	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73131
9	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
10	GSK Investigational Site	Mempis	Tennessee	United States	38119
11	GSK Investigational Site	Murray	Utah	United States	84107
12	GSK Investigational Site	Saint George	Utah	United States	84770
13	GSK Investigational Site	Abingdon	Virginia	United States	24210
14	GSK Investigational Site	Bellevue	Washington	United States	98004
15	GSK Investigational Site	Bruxelles		Belgium	1070
16	GSK Investigational Site	Hamilton	Ontario	Canada	L8N 4A6
17	GSK Investigational Site	Bron Cedex		France	69677
18	GSK Investigational Site	Marseille Cedex 20		France	13915
19	GSK Investigational Site	Montpellier cedex 5		France	34295
20	GSK Investigational Site	Paris		France	75014
21	GSK Investigational Site	Saint-Priest en Jarez		France	42270
22	GSK Investigational Site	Suresnes		France	92151
23	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
24	GSK Investigational Site	Kirchheim -Teck	Baden-Wuerttemberg	Germany	73230
25	GSK Investigational Site	Fulda	Hessen	Germany	36043
26	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein	Germany	24576
27	GSK Investigational Site	Jena	Thueringen	Germany	07740
28	GSK Investigational Site	Kanagawa		Japan	252-0392
29	GSK Investigational Site	Miyagi		Japan	980-8574
30	GSK Investigational Site	Portsmouth	Hampshire	United Kingdom	PO6 3LY
31	GSK Investigational Site	Cambridge		United Kingdom	CB2 0QQ
32	GSK Investigational Site	Leicester		United Kingdom	LE3 9QP