This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
163
Depemokimab will be administered
Mepolizumab will be administered
Placebo matching to mepolizumab will be administered.
Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day)
Participants must be in remission at both Weeks 36 and 52.
Time frame: Up to Week 52
Number of participants in each category of accrued duration of remission
Total accrued duration of remission is the accrued number of weeks where BVAS = 0 plus OCS dose \<= 4 mg/day over the 52-week intervention period. The accrued duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks or more than or equal to (\>=) 36 weeks.
Time frame: Up to Week 52
Number of participants with total accrued duration of remission
Total accrued duration of remission is the accrued number of weeks where BVAS = 0 plus OCS dose \<= 4 mg/day over the 52-week intervention period.
Time frame: Up to Week 52
Time to first EGPA relapse
The time to first EGPA relapse will be calculated from the date of first dose of study intervention and start date of the EGPA relapse.
Time frame: Up to Week 52
Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52)
Number of participants receiving the mean OCS dose (categorized as 0, \>0 to \<=4, \>4 to \<=7.5 or \>7.5 mg/day) will be assessed during the last 4 weeks of the study treatment period (Weeks 49 to 52).
Time frame: Weeks 49 to 52
Number of participants achieving remission (BVAS = 0 and OCS <= 4 mg/day) within the first 24 weeks with continued remission until Week 52
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Placebo matching to depemokimab will be administered.
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Gainesville, Florida, United States
GSK Investigational Site
Rochester, Minnesota, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
La Plata, Argentina
...and 66 more locations
Time frame: Up to Week 52
Number of participants achieving remission using the European League against Rheumatism (EULAR) definition (BVAS = 0 and OCS <=7.5 mg/day) at Weeks 36 and 52
Time frame: At Weeks 36 and 52
Number of participants in each category of accrued duration of remission according to the EULAR definition of remission (BVAS = 0 plus OCS <=7.5 mg/day) over 52-week intervention period
Total accrued duration of remission according to the EULAR definition of remission is the accrued number of weeks where BVAS = 0 plus OCS dose \<=7.5 mg/day over the 52 week intervention period categorized as zero weeks; \>0 to \<12 weeks; 12 to \<24 weeks; 24 to \<36 weeks or \>= 36 weeks.
Time frame: Up to Week 52
Number of participants with total accrued duration of remission according to the EULAR definition of remission
Total accrued duration of remission according to the EULAR definition of remission is the accrued number of weeks where BVAS=0 plus OCS \<=7.5 mg/day over the 52-week intervention period.
Time frame: Up to Week 52
Number of participants with remission (BVAS=0 and OCS <=7.5 mg/day) within the first 24 weeks with continued remission until Week 52
Time frame: Up to Week 52