Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298061
Recruitment Status : Active, not recruiting
First Posted : September 29, 2017
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : April 14, 2015
Estimated Primary Completion Date : July 29, 2022
Estimated Study Completion Date : July 29, 2022


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.




Primary Outcome Measures :
  1. Number of subjects with corticosteroid use [ Time Frame: Up to 3 years approximately ]
    The use of corticosteroids excluding inhaled and topical steroids will be summarized.

  2. Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298061


Locations
Layout table for location information
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80206
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20892
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02118-2307
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63110
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73131
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
GSK Investigational Site
Mempis, Tennessee, United States, 38119
United States, Utah
GSK Investigational Site
Murray, Utah, United States, 84107
GSK Investigational Site
Saint George, Utah, United States, 84770
United States, Virginia
GSK Investigational Site
Abingdon, Virginia, United States, 24210
United States, Washington
GSK Investigational Site
Bellevue, Washington, United States, 98004
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1070
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 4A6
France
GSK Investigational Site
Bron Cedex, France, 69677
GSK Investigational Site
Marseille Cedex 20, France, 13915
GSK Investigational Site
Montpellier cedex 5, France, 34295
GSK Investigational Site
Paris, France, 75014
GSK Investigational Site
Saint-Priest en Jarez, France, 42270
GSK Investigational Site
Suresnes, France, 92151
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Kirchheim -Teck, Baden-Wuerttemberg, Germany, 73230
GSK Investigational Site
Fulda, Hessen, Germany, 36043
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Jena, Thueringen, Germany, 07740
Japan
GSK Investigational Site
Kanagawa, Japan, 252-0392
GSK Investigational Site
Miyagi, Japan, 980-8574
United Kingdom
GSK Investigational Site
Portsmouth, Hampshire, United Kingdom, PO6 3LY
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
GSK Investigational Site
Leicester, United Kingdom, LE3 9QP
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03298061    
Other Study ID Numbers: 116841
2014-003162-25 ( EudraCT Number )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Eosinophilic Granulomatosis
MEA115921
Polyangiitis
Long-term access program
mepolizumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Churg-Strauss Syndrome
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents