Table 1 Asthma biologic studies with pre-defined OCS-tapering schedules
From: Development of methodology for assessing steroid-tapering in clinical trials for biologics in asthma
Study | Study initiation | Trial type | Treatment | Dosing frequency | Patients (ITT) |
|---|---|---|---|---|---|
Key single-center study [19] (NCT00292877) | 2005 | Phase 2 RCT Double-blind Parallel-group | Mepolizumab 750 mg IV or placebo | Every 4 weeks for 16 weeks | 20 |
SIRIUS [20] (NCT01691508) | 2012 | Phase 3 Multicenter RCT Double-blind Parallel-group | Mepolizumab 100 mg SC or placebo | Every 4 weeks for 24 weeks | 135 |
ZONDA [21] (NCT02075255) | 2014 | Phase 3 Multicenter RCT Double-blind Parallel-group | Benralizumab 30 mg SC or placebo | Every 4 weeks for 12 weeks followed by every 4 weeks or every 8 weeks for 16 weeks (total duration: 28 weeks) | 220 |
VENTURE [22] (NCT02528214) | 2015 | Phase 3 Multicenter RCT Double-blind Parallel-group | Dupilumab 300 mg SC or placebo | Every 2 weeks for 24 weeks | 210 |
2018 | Phase 3b Multicenter Open-label Single-arm | Benralizumab 30 mg SC | Every 4 weeks for 8 weeks (first 3 doses) followed by every 8 weeks until end of treatment* | 598 |