4/29/2023 0 Comments Pathway study center![]() Key secondary endpoints include the effect of tezepelumab on lung function, asthma control and health-related quality of life. The primary efficacy endpoint is the annualized asthma exacerbation rate during the 52-week treatment period. All patients will receive their prescribed controller medications without change throughout the study. The study comprises a 5-6-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. The study population includes approximately equal proportions of patients with high (≥ 300 cells/μL) and low (< 300 cells/μL) blood eosinophil counts. NAVIGATOR ( NCT03347279) is an ongoing randomized, double-blind, placebo-controlled trial in adults (18-80 years old) and adolescents (12-17 years old) with severe, uncontrolled asthma, who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids (N = 1061). This article reports the design and objectives of the pivotal phase 3 NAVIGATOR study. In the PATHWAY phase 2b study ( NCT02054130), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline disease phenotype. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. Patients with severe, uncontrolled asthma have a significant unmet need for new treatments that have broader effects on airway inflammation, and that provide greater improvements in asthma outcomes than currently approved biologics and standard-of-care therapies. 10 Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.9 Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.8 Biometrics, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.7 BioPharma Study Management, Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Mississauga, ON, Canada. ![]() 5 Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.4 Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.3 Translational Science and Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.2 Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA. 1 Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK. ![]()
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