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 : June 1, 2018
|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 available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||119 participants|
|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)|
|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 :||January 2, 2020|
|Estimated Study Completion Date :||January 2, 2020|
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.
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.
Subjects who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298061
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|