A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy

Conditions

Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy

Brief summary

Remission (i.e., a Birmingham Vasculitis Activity Score (BVAS)=0 and a dose of oral corticosteroids (OCS) ≤4mg/day) at both Week 36 and Week 52.

Detailed description

Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period categorised as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or ≥36 weeks., Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period., Time to first EGPA relapse., Mean OCS dose during the last 4 weeks of the study treatment period (Weeks 49 to 52) categorised as 0, >0 to ≤4, >4 to ≤7.5 or >7.5 mg/day., Remission (BVAS=0 and OCS ≤4mg/day) within the first 24 weeks with continued remission until Week 52., Remission using the European League against Rheumatism (EULAR) definition; BVAS=0 and OCS ≤7.5 mg/day at both Week 36 and Week 52., Total accrued duration of remission according to the EULAR definition of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS≤7.5 mg/day over the 52-week intervention period categorised as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or ≥36 weeks., Total accrued duration of remission according to the EULAR definition of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS ≤7.5 mg/day over the 52-week intervention period., Remission (BVAS=0 and OCS ≤7.5 mg/day) within the first 24 weeks with continued remission until Week 52.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMEPOLIZUMAB

DRUGPlacebo for Depemokimab Injection

DRUGPlacebo for Mepolizumab Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Remission (i.e., a Birmingham Vasculitis Activity Score (BVAS)=0 and a dose of oral corticosteroids (OCS) ≤4mg/day) at both Week 36 and Week 52.	—

Secondary

Measure	Time frame
Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period categorised as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or ≥36 weeks., Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period., Time to first EGPA relapse., Mean OCS dose during the last 4 weeks of the study treatment period (Weeks 49 to 52) categorised as 0, >0 to ≤4, >4 to ≤7.5 or >7.5 mg/day., Remission (BVAS=0 and OCS ≤4mg/day) within the first 24 weeks with continued remission until Week 52., Remission using the European League against Rheumatism (EULAR) definition; BVAS=0 and OCS ≤7.5 mg/day at both Week 36 and Week 52., Total accrued duration of remission according to the EULAR definition of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS≤7.5 mg/day over the 52-week intervention period categorised as zero w	—

Measure

Time frame

Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period categorised as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or ≥36 weeks., Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period., Time to first EGPA relapse., Mean OCS dose during the last 4 weeks of the study treatment period (Weeks 49 to 52) categorised as 0, >0 to ≤4, >4 to ≤7.5 or >7.5 mg/day., Remission (BVAS=0 and OCS ≤4mg/day) within the first 24 weeks with continued remission until Week 52., Remission using the European League against Rheumatism (EULAR) definition; BVAS=0 and OCS ≤7.5 mg/day at both Week 36 and Week 52., Total accrued duration of remission according to the EULAR definition of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS≤7.5 mg/day over the 52-week intervention period categorised as zero w

—

Countries

Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed