Table 1 Ongoing studies of tezepelumab in patients with asthma and healthy volunteers
ClinicalTrials.gov identifier | Estimated start and completion dates | Patient population | Phase | Primary outcome |
|---|---|---|---|---|
NCT02698501 (UPSTREAM) | 2016–2019 | 40 adults with asthma requiring ICS (± LABA) | 2 | Mannitol PD15 |
NCT03989544 (PATH-BRIDGE) | 2019–2019 | 315 healthy adults | 1 | Pharmacokinetics of SC administration via accessorized pre-filled syringe or autoinjector compared with vial and syringe |
NCT03968978 (PATH-HOME) | 2019–2020 | 216 adults and adolescents with severe asthma | 3 | Successful SC administration via accessorized pre-filled syringe or autoinjector at home versus in the clinic |
NCT03347279 (NAVIGATOR) | 2019–2020 | 1038 adults and adolescents with severe, uncontrolled asthma, taking medium- to high-dose ICS and at least one additional asthma controller with or without OCS | 3 | Annualized asthma exacerbation rate |
NCT03406078 (SOURCE) | 2018–2020 | 150 adults with oral corticosteroid-dependent asthma (Americas, Europe) | 3 | Reduction in daily OCS dose |
NCT03688074 (CASCADE) | 2018–2020 | 116 adults with inadequately controlled moderate-to-severe asthma, taking ICS and at least one additional asthma controller | 2 | Number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies |
NCT03706079 (DESTINATION) | 2019–2022 | 966 adults and adolescents with severe, uncontrolled asthma | 3 | Exposure-adjusted incidence of adverse events and serious adverse events |
NCT04048343 (NOZOMI) | 2019–2021 | 66 Japanese adults and adolescents with inadequately controlled severe asthma | 3 | Rate of adverse events |
NCT03927157 (DIRECTION) | 2019–2023 | 396 Chinese adults with severe, uncontrolled asthma taking medium- to high-dose ICS and at least one additional asthma controller with or without OCS | 3 | Annualized asthma exacerbation rate |