Tezepelumab clinical trials in asthma
| Phase study nameNCT number | Design | Patient populationKey inclusion criteria (N) | Treatment dose | Primary objective |
|---|---|---|---|---|
| Phase 2PATHWAYNCT02054130 | Randomized, placebo-controlled, double-blind, multiple-dose trial to evaluate safety and efficacy | Adults with severe, uncontrolled asthma and a history of exacerbations during the year prior to trial entry (550) | 70 mg or 210 mg SC Q4W or 280 mg SC or placebo Q2W | Assess the effect of tezepelumab on asthma exacerbations at week 52 [57] |
| Phase 3NAVIGATORNCT03347279 | Randomized, placebo-controlled, double-blind trial to evaluate efficacy and safety | Adults and adolescents with severe, uncontrolled asthma on medium- to high-dose ICS and ≥ 1 additional asthma controller medication with/without OCS (1,059) | 210 mg SC or placebo Q4W | Assess the effect of tezepelumab on asthma exacerbations at week 52 [60] |
| Phase 3SOURCENCT03406078 | Randomized, placebo-controlled, double-blind trial to evaluate efficacy and safety | Adults with OCS-dependent asthma; a stable daily dose of OCS 7.5 mg to 30 mg for ≥ 1 month; 35% with eosinophils ≥ 300 cells/µL (150) | 210 mg SC or placebo Q4W | Assess the effect of tezepelumab in reducing the prescribed OCS maintenance dose at week 48 while not losing asthma control [64, 65] |
| Phase 3DESTINATIONNCT03706079 | Randomized, placebo-controlled, double-blind extension trial to evaluate safety and tolerability | Adults and adolescents with severe, uncontrolled asthma; previously enrolled in NAVIGATOR or SOURCE trial | 210 mg SC or placebo Q4W | Assess a long-term safety and tolerability of tezepelumab over 104 weeks [75, 79] |
| Phase 2UPSTREAMNCT02698501 | Randomized, placebo-controlled, double-blind trial to evaluate AHR | Adults with uncontrolled asthma and AHR to inhale mannitol despite any stable dose of ICS (40) | 700 mg IV or placebo Q4W | Assess the effect of tezepelumab on AHR to mannitol at 12 weeks [66] |
| Phase 2CASCADENCT03688074 | Randomized, placebo-controlled, double-blind trial to evaluate airway inflammation | Adults with inadequately controlled moderate-to-severe asthma on ICS and ≥ 1 additional asthma controller (116) | 210 mg SC or placebo Q4W | Assess the effects of tezepelumab on change from baseline to week 28 in airway submucosal inflammatory cells [67, 68] |
| Phase 3NOZOMINCT04048343 | Open-label, single-arm trial to evaluate safety and tolerability | Adults and adolescents with severe uncontrolled asthma on medium- to high-dose ICS and ≥ 1 additional asthma controller, with/without OCS, and a history of ≥ 1 exacerbation during the year prior to trial entry (65) | 210 mg SC tezepelumab Q4W | Assess a long-term safety and tolerability of tezepelumab over 52 weeks [76] |
SC: subcutaneous; Q4W: every 4 weeks; ICS: inhaled corticosteroids; OCS: oral corticosteroids; AHR: airway hyperresponsiveness; IV: intravenous
Note. Adapted with permission from “Targeting TSLP in Asthma” by Parnes JR, Molfino NA, Colice G, Martin U, Corren J, Menzies-Gow A. J Asthma Allergy. 2022;15:749–65 (https://doi.org/10.2147/JAA.S275039). CC BY-NC.
