drugset / Trial / NCT03347279
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
RandomizedParallel-groupTriple-blindTreatment
Summary
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
Timeline
- Start
- 2017-11-23
- Primary completion
- 2020-09-08
- Completion
- 2020-11-12
Outcome
Met primary endpoint
registry analysis (superiority test); Tezepelumab 210mg Q4W vs Placebo; p <0.001; Rate Ratio 0.44 (95% CI 0.37 to 0.53); Negative Binomial NCT03347279 ↗
registry analysis (superiority test); Tezepelumab 210mg Q4W vs Placebo; p <0.001; Rate Ratio 0.59 (95% CI 0.46 to 0.75); Negative Binomial NCT03347279 ↗
release “NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks” amgen.com ↗
release “NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks” amgen.com ↗
Publications
- Feleszko W, Caminati M, Gern JE, Johnston SL, Marchese C, Clarke D, Ambrose CS, Lindsley AW. Effect of tezepelumab on asthma exacerbations co-occurring with infection-attributed acute respiratory illnesses. Ann Allergy Asthma Immunol. 2026 Jan;136(1):61-65.e1. doi: 10.1016/j.anai.2025.09.015. Epub 2025 Oct 8.
- Yang X, Wang L, Huang K, Tang W, Berame EJ, Park HS, Hunter G, Jiang W, Wu CC, Min CW, Domek-Zielinska K, Lal H, Molfino NA, Ponnarambil SS, Zhong N. Efficacy and Safety of Tezepelumab in Adults With Severe, Uncontrolled Asthma in Asia: Results From the Phase 3 DIRECTION Study. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3011-3020.e9. doi: 10.1016/j.jaip.2025.07.046. Epub 2025 Aug 7.
- Pavord ID, Brightling CE, Korn S, Martin NL, Ponnarambil SS, Molfino NA, Parnes JR, Ambrose CS. Tezepelumab can Restore Normal Lung Function in Patients with Severe, Uncontrolled Asthma: Pooled Results from the PATHWAY and NAVIGATOR Studies. Pulm Ther. 2025 Jun;11(2):315-325. doi: 10.1007/s41030-025-00294-2. Epub 2025 Apr 26.
- Jacobs JS, Han JK, Lee JK, Laidlaw TM, Martin NL, Caveney S, Ambrose CS, Martin N, Spahn JD, Hoyte FCL. Effect of Tezepelumab on Sino-Nasal Outcome Test (SNOT)-22 Domain and Symptom-Specific Scores in Patients with Severe, Uncontrolled Asthma and a History of Chronic Rhinosinusitis with Nasal Polyps. Adv Ther. 2025 Jan;42(1):510-522. doi: 10.1007/s12325-024-03006-5. Epub 2024 Nov 8.
- Wechsler ME, Brusselle G, Virchow JC, Bourdin A, Kostikas K, Llanos JP, Roseti SL, Ambrose CS, Hunter G, Jackson DJ, Castro M, Lugogo N, Pavord ID, Martin N, Brightling CE. Clinical response and on-treatment clinical remission with tezepelumab in a broad population of patients with severe, uncontrolled asthma: results over 2 years from the NAVIGATOR and DESTINATION studies. Eur Respir J. 2024 Dec 5;64(6):2400316. doi: 10.1183/13993003.00316-2024. Print 2024 Dec.
- Carr TF, Moore WC, Kraft M, Brusselle G, Castro M, Chupp GL, Wechsler ME, Hunter G, Lindsley AW, Llanos JP, Burke LK, Chandarana S, Ambrose CS. Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma Across Multiple Clinically Relevant Subgroups in the NAVIGATOR Study. Adv Ther. 2024 Jul;41(7):2978-2990. doi: 10.1007/s12325-024-02889-8. Epub 2024 May 27.
- Corren J, Menzies-Gow A, Bimmel J, McGuinness A, Almqvist G, Bowen K, Griffiths JM, Ponnarambil S, Bourdin A, Israel E, Colice G, Brightling CE, Wechsler ME; PATHWAY and NAVIGATOR study investigators. Tezepelumab for the treatment of severe asthma: a plain language summary of the PATHWAY and NAVIGATOR studies. Immunotherapy. 2023 Nov;15(16):1327-1340. doi: 10.2217/imt-2023-0109. Epub 2023 Sep 29.
- Menzies-Gow A, Ambrose CS, Colice G, Hunter G, Cook B, Molfino NA, Llanos JP, Israel E. Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Adv Ther. 2023 Nov;40(11):4957-4971. doi: 10.1007/s12325-023-02659-y. Epub 2023 Sep 19.
- Pavord ID, Hoyte FCL, Lindsley AW, Ambrose CS, Spahn JD, Roseti SL, Cook B, Griffiths JM, Hellqvist A, Martin N, Llanos JP, Martin N, Colice G, Corren J. Tezepelumab reduces exacerbations across all seasons in patients with severe, uncontrolled asthma (NAVIGATOR). Ann Allergy Asthma Immunol. 2023 Nov;131(5):587-597.e3. doi: 10.1016/j.anai.2023.08.015. Epub 2023 Aug 23.
- Menzies-Gow A, Bourdin A, Chupp G, Israel E, Hellqvist A, Hunter G, Roseti SL, Ambrose CS, Llanos JP, Cook B, Corren J, Colice G. Effect of tezepelumab on healthcare utilization in patients with severe, uncontrolled asthma: The NAVIGATOR study. Ann Allergy Asthma Immunol. 2023 Sep;131(3):343-348.e2. doi: 10.1016/j.anai.2023.05.028. Epub 2023 May 30.
- Corren J, Menzies-Gow A, Chupp G, Israel E, Korn S, Cook B, Ambrose CS, Hellqvist A, Roseti SL, Molfino NA, Llanos JP, Martin N, Bowen K, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Am J Respir Crit Care Med. 2023 Jul 1;208(1):13-24. doi: 10.1164/rccm.202210-2005OC.
- Menzies-Gow A, Wechsler ME, Brightling CE, Korn S, Corren J, Israel E, Chupp G, Bednarczyk A, Ponnarambil S, Caveney S, Almqvist G, Golabek M, Simonsson L, Lawson K, Bowen K, Colice G; DESTINATION study investigators. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study. Lancet Respir Med. 2023 May;11(5):425-438. doi: 10.1016/S2213-2600(22)00492-1. Epub 2023 Jan 23.
- Yin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.
- Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist A, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.
- Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist A, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tezepelumab | Monoclonal antibody | 210 mg | Subcutaneous |