Table 3.
Summary of ongoing reslizumab studies in patients with eosinophilic asthma.
| ClinicalTrials.gov identifier and study status | Design | Patients | No. pts* | Study treatment | Study endpoints |
|---|---|---|---|---|---|
|
NCT02452190 (ongoing) |
Ph III, r, db, pll | Aged ⩾12 years, uncontrolled asthma, elevated BE | 400 | Res 110 mg SC q4w or PL q4w × 52 weeks | Primary: frequency of asthma exacerbations Secondary†: FEV1, AQLQ, ACQ, AEs |
|
NCT02501629 (ongoing) |
Ph III, r, db, pll | Aged ⩾12 years, OCS-dependent, elevated BE | 152 | Res 110 mg SC q4w or PL q4w × 24 weeks | Primary: percentage reduction in daily OCS dose
versus BL Secondary†: Pts with ⩾50% reduction in OCS dose, pts with OCS dose reduction to ⩽5 mg/day, annualized rate of CAE, AQLQ |
|
NCT02559791 (final data collection October 2016) |
Ph II/III, sb (pt) | Aged 18–75 years, prednisone-dependent EA, MP pretreated (100 mg SC, ⩾6 mo) | 15 | PL q4w × 8 weeks then Res 3 mg/kg IV q4w × 16 weeks | Primary: blood and sputum eosinophils Secondary†: ILC2, CD4+, CD8+, CD34+, FEV1, ACQ |
*
Estimated. †Not exhaustive.
ACQ, asthma control questionnaire; AE, adverse event; AQLQ, asthma quality of life questionnaire; BE, blood eosinophils; BL, baseline; CAE, clinical asthma exacerbations; db, double-blind; EA, eosinophilic asthma; FEV1, forced expiratory volume in 1 s; ILC2, type 2 innate lymphoid cells; IV, intravenous; MP, mepolizumab; OCS, oral corticosteroid; Ph, phase; PL, placebo; pll, parallel; pt, patient; q4w, every 4 weeks; r, randomized; Res, reslizumab; sb single-blind; SC, subcutaneous.