A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care Therapy|
- Total accrued duration of remission [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]The accrued number of weeks where BVAS=0 plus prednisolone/prednisone dose <=4 mg/day over the 52 week study treatment period reported as proportion of subjects achieving remission in the following categories: Zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks, >=36 weeks
- The proportion of subjects who are in remission at both Weeks 36 and 48 of the study treatment period [ Time Frame: Weeks 36 and 48 ] [ Designated as safety issue: No ]Remission is defined as BVAS=0 and prednisolone/prednisone dose <=4 mg/day
- Time to first confirmed EGPA relapse [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]EGPA relapse is defined as worsening or persistence of active disease characterised by active vasculitis (BVAS >0) or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire (ACQ) 6 score or active nasal and/or sinus disease with a corresponding worsening in at least one of the sino-nasal symptom questions warranting an increased dose of OCS therapy or an increased dose or addition of immunosuppressive therapy or hospitalisation related to EGPA worsening
- The proportion of subjects with an average daily prednisolone/prednisone dose of 0 mg, >0 to <=4.0 mg, >4.0 to <=7.5 mg and >7.5 mg during the last 4 weeks of the study treatment period (48 through 52) [ Time Frame: Week 48 to Week 52 ] [ Designated as safety issue: No ]
- The proportion of subjects in each treatment group who achieve remission (BVAS=0 and prednisolone/prednisone dose <=4 mg/day) within the first 24 weeks of the study and then remain in remission for the remainder of the study treatment period [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Mepolizumab 300 mg
Each subject will receive mepolizumab 300 mg subcutaneous (SC) injection every 4 weeks (13 administrations) along with standard care. It will be administered as 3 separate injections (100 mg each- total dose 300 mg); individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall.
Mepolizumab will be provided as a lyophilized cake in sterile vials for individual use to be reconstituted with sterile water for Injection, just prior to use.
Placebo Comparator: Placebo
Each subject will receive placebo (0.9% sodium chloride) SC injection every 4 weeks (13 administrations) along with standard care. It will be administered as 3 separate injections; individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall.
Placebo will be available as 0.9% sodium chloride
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020889
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|