Table 1.
Recent and ongoing clinical trials of the TSLP-targeting monoclonal antibody tezepelumab
| Trial | Status | Trial participants | Interventions | Result | Clinical trials identifier and Refs |
|---|---|---|---|---|---|
| Healthy individuals | |||||
| Pharmacokinetics of tezepelumab delivered by APFS, AI, or vial and syringe, phase I | Completed Dec. 2019 | Healthy adult individuals | Tezepelumab | NA | NCT03989544 |
| Tezepelumab pharmacokinetics, phase I | Completed Oct. 2020 | Healthy Chinese individuals | Tezepelumab versus placebo | NA | NCT04362410 |
| Asthma | |||||
| Tezepelumab home use, phase III | Completed Jun. 2020 | Adolescents and adults with severe asthma | Tezepelumab administered by APFS versus AI | APFS and AI were functional and reliable, and performed equally well at home and in the clinic | NCT03968978 (ref.185) |
| Efficacy and safety of tezepelumab in reducing oral corticosteroid use, phase III (SOURCE) | Completed Sep. 2020 | Adults with oral corticosteroid-dependent asthma | Tezepelumab versus placebo | NA | NCT03406078 (ref.186) |
| Efficacy and safety of tezepelumab, phase III (NAVIGATOR) | Completed Nov. 2020 | Adults and adolescents with severe uncontrolled asthma | Tezepelumab versus placebo | Tezepelumab associated with fewer exacerbations and better lung function, asthma control and health-related quality of life than placebo | NCT03347279 (ref.93) |
| Effects of tezepelumab on airway inflammation, phase II (CASCADE) | Completed Nov. 2020 | Adults with uncontrolled asthma and other hypersensitivity airway diseases | Tezepelumab versus placebo | Tezepelumab improved clinical outcomes in patients with asthma, with reduction of eosinophilic airway inflammation; it also reduced hyperresponsiveness to mannitol | NCT03688074 (refs90,187,188) |
| Long-term safety of tezepelumab, phase III | Completed Mar. 2021 | Japanese adults and adolescents with inadequately controlled severe asthma | Tezepelumab | NA | NCT04048343 |
| Pharmacokinetics of tezepelumab, phase I | Recruiting | Children with asthma | Tezepelumab | NA | NCT04673630 |
| Efficacy and safety of tezepelumab, phase III | Recruiting | Adults with severe uncontrolled asthma | Tezepelumab versus placebo | NA | NCT03927157 |
| Extension study on safety and tolerability of tezepelumab, phase III (DESTINATION) | Active, not recruiting | Adults and adolescents with severe, uncontrolled asthma | Tezepelumab versus placebo | NA | NCT03706079 |
| Effect of tezepelumab on the immune response to influenza vaccination, phase III (VECTOR) | Active, not recruiting | Adolescents and young adults with moderate to severe asthma | Tezepelumab versus placebo | NA | NCT05062759 |
| Effect of tezepelumab on airway structure and function, phase III (WAYFINDER) | Not yet recruiting | Adults with uncontrolled moderate-to-severe asthma | Tezepelumab versus placebo | NA | NCT05280418 |
| Efficacy and safety of tezepelumab in reducing oral corticosteroid use, phase III | Not yet recruiting | Adults with severe asthma on high-dose corticosteroids | Tezepelumab | NA | NCT05274815 |
| Other allergic and chronic inflammatory diseases | |||||
| Safety and efficacy of tezepelumab, phase II | Terminated | Patients with moderate-to-severe atopic dermatitis | Tezepelumab versus placebo | Tezepelumab did not reach the targeted efficacy level pre-established for this patient population | NCT03809663 |
| Effect of tezepelumab in COPD exacerbation, phase II | Recruiting | Patients with moderate-to-very-severe COPD | Tezepelumab versus placebo | NA | NCT04039113 |
| Efficacy and safety of tezepelumab, phase II | Recruiting | Adults with chronic spontaneous urticaria | Two doses of tezepelumab versus omalizumab and placebo | NA | NCT04833855 |
| Efficacy and safety of tezepelumab, phase III | Recruiting | Patients with severe chronic rhinosinusitis with nasal polyps | Tezepelumab versus placebo | NA | NCT04851964 |
AI, autoinjector; APFS, accessorized pre-filled syringe; COPD, chronic obstructive pulmonary disease; NA, not available.